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Sample records for beclomethasone

  1. Beclomethasone Nasal Spray

    Science.gov (United States)

    ... symptoms may begin to improve a few days after you first use beclomethasone, but it may take 1 ... your symptoms get worse or do not improve after you use beclomethasone nasal spray for 3 weeks. If ...

  2. Beclomethasone Nasal Spray

    Science.gov (United States)

    Beclomethasone nasal spray is used to relieve symptoms of sneezing, runny, stuffy, or itchy nose (rhinitis) caused by hay fever, other ... nose) after nasal polyp removal surgery. Beclomethasone nasal spray should not be used to treat symptoms (e. ...

  3. A comparison of beclomethasone dipropionate aqueous nasal spray and beclomethasone dipropionate pressurized nasal spray in the management of seasonal rhinitis.

    OpenAIRE

    Dunn, A. M.; Wilson, R.S.; Baggott, P. J.

    1984-01-01

    Forty patients with seasonal rhinitis and a proven sensitivity to pollens were studied for 2 weeks during the pollen season of 1982. The study was carried out according to a double-blind, double-dummy design. All patients received 100 micrograms beclomethasone dipropionate (BDP) into each nostril twice daily (400 micrograms/day) on a randomized basis, from either the aqueous nasal spray or the pressurized nasal spray (Beconase Nasal Spray). Analysis of patients' symptom scores, additional sym...

  4. Formulation and evaluation of CFC free inhalers for beclomethasone dipropionate

    Directory of Open Access Journals (Sweden)

    Gopala Krishna Murthy Talasila

    2013-06-01

    Full Text Available Beclomethasone dipropionate CFC free inhalation formulations were developed with a view to treat asthma prophylactically. Dry powder inhalers (DPI for beclomethasone dipropionate were prepared with different grades of lactose monohydrate. The influence of carrier and overages on performance of DPI was studied. Metered dose inhalers (MDI with HFA based propellants were formulated with various doses, overages and different concentrations of alcohol. Formulated DPI and MDI were evaluated for various official and unofficial quality control tests. The influence of over doses on valve delivery, effect of overages on emitted dose and influence of alcohol on spray pattern from MDI were studied. The better fine particle fraction and emitted dose were obtained from the DPI formulated with 10:90 ratio of fine lactose: coarse lactose and with 20% w/w overages. The studies on MDI revealed that the 15% of overdoses are required for effective valve delivery and 20% overages are required for 100% drug delivery. 5-10%v/v alcohol was found to be preferable to get optimum emitted dose and fine particle fraction.

  5. COMPARATIVE EFFICACY OF INHALED DRUGS FORMOTEROL / BECLOMETHASONE AND FORMOTEROL / BUDESONIDE AND BRONCHIAL ASTHMA

    OpenAIRE

    Nikitin, V. A.; O. A. Lepuchova; L. V. Vasilieva; E. P. Karpuchina

    2016-01-01

    There were examined 86 patients aged 20 to 65 years with a diagnosis of bronchial asthma (BA). The objective is to evaluate the level of disease control, to study the effectiveness, safety and usability when used Foster (beclomethasone dipropionate and formoterol fumarate fixed combination) Combination and Foradil (formoterol fumarate and budesonide in free combination). Patients were divided into 2 groups randomly. The first group received Foster (beclomethasone dipropionate and formoterol f...

  6. Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD

    DEFF Research Database (Denmark)

    Singh, D.; Nicolini, G.; Bindi, E.;

    2014-01-01

    Background: The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients. Methods: The trial was a 12-week multicentre, randomised, double-blind, double dummy study...

  7. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations

    DEFF Research Database (Denmark)

    Singh, Dave; Kampschulte, Jorg; Wedzicha, Jadwiga A;

    2013-01-01

    comparison of extrafine beclomethasone dipropionate and formoterol in a combination inhaler with extrafine formoterol; the co-primary end-points are exacerbation rates over 48 weeks and improvement in forced expiratory volume in 1 s over 12 weeks. The traditional physician diagnosis of exacerbations is a co...

  8. Adrenal function in children with bronchial asthma treated with beclomethasone dipropionate or budesonide

    DEFF Research Database (Denmark)

    Bisgaard, H; Damkjaer Nielsen, M; Andersen, B;

    1988-01-01

    unstimulated diurnal production of glucocorticosteroids was assessed by measurements of free cortisol in 24-hour urine samples. Free cortisol in urine was found a valid measure of the total diurnal excretion of cortisol metabolites, since it exhibited a good correlation to the fractional cortisol metabolites...... difference was found between the two topical steroids (probability value 5.3%), and yet the suppression was apparent in the group of children treated with beclomethasone dipropionate but not in the group of children treated with budesonide. Further studies are desirable in order to ascertain whether...

  9. COMPARATIVE EFFICACY OF INHALED DRUGS FORMOTEROL / BECLOMETHASONE AND FORMOTEROL / BUDESONIDE AND BRONCHIAL ASTHMA

    Directory of Open Access Journals (Sweden)

    V. A. Nikitin

    2016-01-01

    Full Text Available There were examined 86 patients aged 20 to 65 years with a diagnosis of bronchial asthma (BA. The objective is to evaluate the level of disease control, to study the effectiveness, safety and usability when used Foster (beclomethasone dipropionate and formoterol fumarate fixed combination Combination and Foradil (formoterol fumarate and budesonide in free combination. Patients were divided into 2 groups randomly. The first group received Foster (beclomethasone dipropionate and formoterol fumarate in a fixed combination, and the second group — Foradil Combi (budesonide and formoterol fumarate in a free combination. Results of the study were assessed for 11-13 days and 3 months. The treatment showed a significant reduction in the severity of clinical symptoms in groups 1 and 2. Respiratory function after 3 months in group 1 improved to 17,4 ± 3,2% (p <0.05, and the second at 6,0 ± 3,3% (p> 0.1. Full control of the disease was achieved in one group, 48.83% of patients, and the second at 44.19% of the patients.

  10. Beclomethasone inhaler versus intravenous lidocaine in the prevention of postoperative airway and throat complaints: a randomized, controlled trial

    International Nuclear Information System (INIS)

    Previous reports indicate that inhaled corticosteroids attenuate airway inflammation. Belcomethasone inhaler was highly effective in the prevention of postoperative airway symptoms. Intravenous lidocaine prior to endotraceal intubation has also been shown to decrease the incidence of postoperative sore throat and cough. The aim of the present study was to compare the effect of beclomethasone inhaler with various clinically used dosages of intravenous lidocaine prior to endotracheal intubation on the incidence and severity of postoperative sore throat, cough, sputum, hoarseness and dysphagia. One-hundred twenty patients undergoing elective operations were assigned to one of four treatments: intravenous lidocaine 1mg/kg (Group L1, n=30), intravenous lidocaine 1.5 mg/kg (Group L2, n=30), beclomethasone inhaler 50 ug (Group B, n=30) or intravenous normal saline (Group C, n=30). The incidence and severity of throat, cough, sputum, hoarseness and dysphagia were compared between the beclomethasone inhaler and intravenous lidocaine groups before they left the operating room, 1 hour later, at time of the first postoperative drink or meal (for assessment of dysphagia) and on the morning after surgery. In the evaluation of postoperative symptoms, the incidence and severity of sore throat were significantly lower in Group L2 and B than Group C (P<0.5) at all time intervals. One and 20 hours after emergence from anesthesia, the incidence and severity of cough were significantly lower in Group L2 and B than Group C (P<0.5). The incidence and severity of soar throat or cough was not significantly different between Groups L2 and B. Throughout the study, incidence and severity of sputum were significantly lower in Group B than group C(P<0.5) Beclomethasone inhaler is comparable with intravenous lidocaine prior to intubation in decreasing postoperative soar throat and cough. In addition, Beclomethasone inhaler decreases the incidence and severity of postoperative sputum. (author)

  11. Clinical efficacy and safety of beclomethasone dipropionate inhalation capsules inhaled by Cyclohaler compared with Becotide Rotacaps inhaled by Rotahaler.

    Science.gov (United States)

    Vink-van Wijngaarden, T; Blom-Ross, M E; Lansdorp, D; Goedhart, D M; Eelhart, J; Guelen, P J; de Vos, D

    1998-09-01

    The study was undertaken to compare the efficacy and safety of beclomethasone dipropionate inhalation powder inhaled by Rotahaler (Becotide Rotacaps, Glaxo Wellcome) and by Cyclohaler (Beclomethasone Cyclocaps, Pharmachemie). Both the Cyclohaler and the Rotahaler are single-dose dry powder inhalation devices for inhalation capsules. 182 asthma patients stabilized on inhaled beclomethasone dipropionate 800 micrograms daily, were randomly assigned to treatment with 800 micrograms beclomethasone dipropionate inhaled by Rotahaler (91 patients) or Cyclohaler (91 patients) in a double-blind manner, using the double-dummy method. It was shown that the asthma remained stable during the 16-week study period with both preparations. There were no statistically significant differences in the pulmonary parameters (morning PEF, evening PEF, FEV1). The test/reference ratio of the morning PEF (99.5%, CI 93.0% - 106.5%) was well within the equivalence interval, which had been set a priori from 85% to 117.6%. There were no marked differences between the Cyclocaps and Rotacaps group in symptom scores and adverse events. A total of 12 patients had an asthma exacerbation: 8 exacerbations occurred in the Rotahaler group and 4 in the Cyclohaler group. The difference was not statistically significant. The use of rescue medication was somewhat higher in the Rotahaler group, but the difference did not reach statistical significance. Significantly more patients (17 patients) withdrew from the study in the Rotahaler group than in the Cyclohaler group (5 patients). In conclusion, there was no difference in asthma control of patients treated with Beclomethasone Cyclocaps inhaled by Cyclohaler and Becotide Rotacaps inhaled by Rotahaler. Both preparations are therapeutically equivalent. PMID:9760014

  12. Solubilization of beclomethasone dipropionate in sterically stabilized phospholipid nanomicelles (SSMs: physicochemical and in vitro evaluations

    Directory of Open Access Journals (Sweden)

    Peh KK

    2012-02-01

    Full Text Available Mohanad Naji Sahib, Shaymaa Abdalwahed Abdulameer, Yusrida Darwis, Kok Khiang Peh, Yvonne Tze Fung TanSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, MalaysiaBackground: The local treatment of lung disorders such as asthma and chronic obstructive pulmonary disease via pulmonary drug delivery offers many advantages over oral or intravenous routes of administration. This is because direct deposition of a drug at the diseased site increases local drug concentrations, which improves the pulmonary receptor occupancy and reduces the overall dose required, therefore reducing the side effects that result from high drug doses. From a clinical point of view, although jet nebulizers have been used for aerosol delivery of water-soluble compounds and micronized suspensions, their use with hydrophobic drugs has been inadequate.Aim: To evaluate the feasibility of sterically stabilized phospholipid nanomicelles (SSMs loaded with beclomethasone dipropionate (BDP as a carrier for pulmonary delivery.Methods: 1,2-Distearoyl-sn-glycero-3-phosphoethanolamine-N-methoxy-poly(ethylene glycol 5000 polymeric micelles containing BDP (BDP-SSMs were prepared by the coprecipitation and reconstitution method, and the physicochemical and in vitro characteristics of BDP-SSMs were investigated.Results: BDP-SSMs were successfully prepared with a content uniformity and reproducibility suitable for pulmonary administration. The maximum solubility of BDP in SSMs was approximately 1300 times its actual solubility. The particle size and zeta potential of BDP-SSMs were 19.89 ± 0.67 nm and -28.03 ± 2.05 mV, respectively. The SSMs system slowed down the release of BDP and all of the aerodynamic values of the aerosolized rehydrated BDP-SSMs were not only acceptable but indicated a significant level of deposition in the lungs.Conclusion: The SSM system might be an effective way of improving the therapeutic index of nebulized, poorly soluble corticosteroids

  13. Quality of life assessment in asthmatic patients receiving fluticasone compared with equipotent doses of beclomethasone or budesonide

    Directory of Open Access Journals (Sweden)

    Thomas Sabin

    2005-01-01

    Full Text Available Aims: To assess the quality of life in patients with asthma receiving either fluticasone or other inhaled steroids like beclomethasone or budesonide. To assess the effect of equipotent dosage of inhaled steroids at 3 months duration. Methods: Patients were randomised to receive either fluticasone or beclomethasone/budesonide. After spirometry, St. George′s Respiratory Questionnaire (SGRQ was administered at baseline and at 15 th , 30 th , 45 th , 60 th and 90 th day, to assess improvement in lung function and HRQoL. Results: Out of 96 patients who were enrolled, eighty patients completed three months duration of the study, while sixteen patients dropped out. Forty patients received fluticasone and forty received either beclomethasone or budesonide. No significant difference (p>0.05 was found in the baseline values of St. George′s Respiratory Questionnaire (SGRQ scores and Forced Expiratory Volume at first second (FEV 1 between the two groups. However, significant difference (p< 0.05 was noted between the above two groups, in Quality of Life (QoL but not in pulmonary functions, on 15th day favoring fluticasone. No significant difference (p>0.05 was noted either in QoL or in pulmonary function tests on subsequent follow-ups. Conclusion: Early response in terms of improved QoL was observed in fluticasone treated group in patients with moderate to severe asthma.

  14. Evaluation of Fluticasone (Flixonase Nasal Spray Versus Beclomethasone (Beconase Nasal Spray in the Treatment of Allergic Rhinitis

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    Reza Farid

    2003-12-01

    Full Text Available Although response to intranasal steroid therapy has been reported in pa¬tients with allergic rhinitis, efficacy of some nasal steroids is noteworthy.This study was undertaken to evaluate the efficacy of a two-week course of Fluticasone (Flixonase nasal spray vs. Beclomethasone (beconase nasal spray in patients with symptoms of allergic rhinitis referred to our clinic. This study reviewed sixty randomized studies with symptoms of allergic rhinitis which sup¬ported common aeroallergens with skin prick test. Patients received a total daily dose of nasal spray of Fluticasone (Flixonase 100 meg bid (N=30 compared with patients with allergic rhinitis who received a total daily dose of Beclomethasone (Beconase 50mcg 2 puffs bid (N=30. Patients were visited before and after therapy, and efficacy of Flixonase. and Beconase was evaluated by the change in nasal symptoms including: nasal discharge, nasal obstruction, nasal itching, and sneezing. After two weeks of treatment nasal symptoms of blockage, discharge, sneezing and itching were significantly better in the group treated with Fluticasone nasal spray (65%, 82%, 67%, 79% respectively (/?100 meg bid Flixonase (Fluticasone intranasal spray is more effective than 50 meg 2 puffs bid Beconase (Beclomethasone intranasal spray. Like asthma, allergic rhinitis is an inflammatory disease and should be managed with anti-in¬flammatory medication.

  15. Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

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    Uwe Sonnemann

    2014-01-01

    Full Text Available Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

  16. Effect of inhaled beclomethasone dipropionate on isocapnic hyperventilation with cold air in asthmatics, measured with forced oscillation technique.

    Science.gov (United States)

    Pennings, H J; Wouters, E F

    1997-03-01

    Isocapnic hyperventilation with cold air (IHCA) is a reliable technique for assessing indirect bronchial hyperresponsiveness in patients with asthma. Impedance measurement of the respiratory system by the forced pseudorandom noise oscillation technique is a sensitive technique to assess changes in bronchial tone after IHCA. The aim of this study was to evaluate the effect of 6 weeks of treatment with beclomethasone dipropionate, 1,000 microg x day-1, on IHCA in asthmatic patients, measured with both forced oscillation technique and flow-volume recordings. Forty patients with mild asthma were included in this double-blind, placebo-controlled parallel-group study. Stratification on the basis of sex was performed to overcome differences in airway diameter. At entry and every 2 weeks during the treatment period, IHCA was performed and patient diaries were evaluated. Characteristic changes in forced oscillation parameters after IHCA were observed in all patients. After 6 weeks of treatment, BDP-treated patients showed statistically significant differences in impedance measurements after IHCA, manifested by significant attenuation of resistance at 8 Hz (preactance at 8 Hz (p=0.01), and resonant frequency (f0) (pFlow-volume recordings showed only a statistically significant change in the decrease of inspiratory vital capacity (IVC) (p=0.01). Furthermore, a significant correlation was observed between serum immunoglobulin E (IgE) levels and the effect of BDP on IHCA, measured with forced oscillation technique. In this study, beclomethasone dipropionate, 1,000 microg x day(-1) for 6 weeks, decreased indirect bronchial hyperresponsiveness as assessed by cold air bronchoprovocation in asthmatic patients. The forced oscillation technique proved a more sensitive method of detecting changes in bronchial tone than flow-volume recordings. PMID:9073002

  17. Non-genomic action of beclomethasone dipropionate on bronchoconstriction caused by leukotriene C4 in precision cut lung slices in the horse

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    Fugazzola Maria

    2012-09-01

    Full Text Available Abstract Background Glucocorticoids have been proven to be effective in the therapy of recurrent airway obstruction (RAO in horses via systemic as well as local (inhalative administration. Elective analysis of the effects of this drug on bronchoconstriction in viable lung tissue offers an insight into the mechanism of action of the inflammatory cascade occurring during RAO which is still unclear. The mechanism of action of steroids in treatment of RAO is thought to be induced through classical genomic pathways. We aimed at electively studying the effects of the glucocorticoid beclomethasone dipropionate on equine precision-cut lung slices (PCLS. PCLS were used to analyze ex-vivo effects of beclomethasone on inhibiting bronchoconstriction in the horse. The inhibiting effect was measured through instillation of a known mediator of inflammation and bronchoconstriction, leukotriene C4. For this, the accessory lobes of 13 horses subjected to euthanasia for reasons unrelated to the respiratory apparatus were used to obtain viable lung slices. Results After 30 minutes of PCLS incubation, beclomethasone showed to significantly inhibit the contraction of the bronchioles after instillation with leukotriene C4. The EC50 values of the two contraction curves (LTC4 with and without BDP differed significantly from each other (p = 0.002. The possibility of a non-genomic rapid mechanism of action seems likely since transcriptional activities require a longer lag period. Conclusions In human neuroendocrinology, high levels of glucocorticoids have been proven to function via a non-genomic mechanism of membrane receptors. The concentration of beclomethasone used on the lung slices in our study can be considered as high. This allows speculation about similar rapid non-genomic mechanisms of high-dosage inhaled glucocorticoids in the lower airways of horses. However, further assessment on a molecular basis is needed to confirm this.

  18. The effect of a structured education program on knowledge and psychomotor skills of patients using beclomethasone dipropionate aerosol for steroid dependent asthma.

    Science.gov (United States)

    Heringa, P; Lawson, L; Reda, D

    1987-01-01

    The purpose of the study was to evaluate the efficacy of a structured education program on knowledge and psychomotor skills of subjects using inhaled beclomethasone dipropionate. The sample was comprised of 26 male outpatients with a mean age of sixty years (range 49-69 yrs) and mean educational level of 11 years (range 7-18 yrs). Subjects were tested to assess knowledge of drug action, self-administration, and side effects. Skill in self-administration was assessed by two independent raters who were blind to group assignment. Then, patients were randomly assigned to an experimental group (n = 13), who received a structured educational program, or a control group (n = 13), who received no structured educational interventions. Patients were retested four weeks after randomization. Subjects in the experimental and control groups did not differ significantly with respect to their initial mean knowledge and performance scores. The post-test mean knowledge score was significantly higher when compared to initial score for each group. Mean knowledge score at post-test did not differ significantly between groups. However, when comparing post-test performance scores to initial scores the experimental group had a significantly greater increase in mean score than the control group. It is concluded that a structured patient education program is an effective method for improving the psychomotor skills necessary for proper use of beclomethasone dipropionate aerosol. PMID:3654237

  19. Monitoring the initial pulmonary absorption of two different beclomethasone dipropionate aerosols employing a human lung reperfusion model

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    Fritz Peter

    2005-02-01

    Full Text Available Abstract Background The pulmonary residence time of inhaled glucocorticoids as well as their rate and extend of absorption into systemic circulation are important facets of their efficacy-safety profile. We evaluated a novel approach to elucidate the pulmonary absorption of an inhaled glucocorticoid. Our objective was to monitor and compare the combined process of drug particle dissolution, pro-drug activation and time course of initial distribution from human lung tissue into plasma for two different glucocorticoid formulations. Methods We chose beclomethasone dipropionate (BDP delivered by two different commercially available HFA-propelled metered dose inhalers (Sanasthmax®/Becloforte™ and Ventolair®/Qvar™. Initially we developed a simple dialysis model to assess the transfer of BDP and its active metabolite from human lung homogenate into human plasma. In a novel experimental setting we then administered the aerosols into the bronchus of an extracorporally ventilated and reperfused human lung lobe and monitored the concentrations of BDP and its metabolites in the reperfusion fluid. Results Unexpectedly, we observed differences between the two aerosol formulations Sanasthmax®/Becloforte™ and Ventolair®/Qvar™ in both the dialysis as well as in the human reperfusion model. The HFA-BDP formulated as Ventolair®/Qvar™ displayed a more rapid release from lung tissue compared to Sanasthmax®/Becloforte™. We succeeded to explain and illustrate the observed differences between the two aerosols with their unique particle topology and divergent dissolution behaviour in human bronchial fluid. Conclusion We conclude that though the ultrafine particles of Ventolair®/Qvar™ are beneficial for high lung deposition, they also yield a less desired more rapid systemic drug delivery. While the differences between Sanasthmax®/Becloforte™ and Ventolair®/Qvar™ were obvious in both the dialysis and lung perfusion experiments, the latter

  20. Development and validation of simultaneous spectrophotometric and TLC-spectrodensitometric methods for determination of beclomethasone dipropionate and salbutamol in combined dosage form

    Science.gov (United States)

    Samir, Ahmed; Lotfy, Hayam M.; Salem, Hesham; Abdelkawy, Mohammed

    2014-07-01

    Spectrophotometric and TLC-spectrodensitometric methods were developed and validated for the simultaneous determination of beclomethasone dipropionate (BEC) and salbutamol (SAL). The spectrophotometric methods include dual wavelength, ratio difference, constant center coupled with a novel method namely, spectrum subtraction and mean centering with mean percentage recoveries and RSD 99.72 ± 1.07 and 99.70 ± 1.12, 100.25 ± 1.12 and 99.89 ± 1.12, 99.66 ± 1.85 and 99.19 ± 1.32, 100.74 ± 1.26 and 101.06 ± 0.90 for BEC and SAL respectively. The TLC-spectrodensitometric method was based on separation of both drugs on TLC aluminum plates of silica gel 60 F254, using benzene: methanol: triethylamine (10:1.5:0.5 v/v/v) as a mobile phase, followed by densitometric measurements of their bands at 230 nm. The mean percentage recoveries and RSD were 99.07 ± 1.25 and 101.35 ± 1.50 for BEC and SAL respectively. The proposed methods were validated according to ICH guidelines and were applied for the simultaneous analysis of the cited drugs in synthetic mixtures and pharmaceutical preparation. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of BEC and SAL in their pharmaceutical formulation with no need for prior separation. The results obtained were statistically compared to each other and to that of the reported HPLC method. The statistical comparison showed that there is no significant difference regarding both accuracy and precision.

  1. Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connor Brian J

    2011-12-01

    Full Text Available Abstract Background The dose-dependent anti-inflammatory effects of a recent fixed combination of extrafine beclomethasone dipropionate/formoterol (BDP/F were investigated using non-invasive markers of inflammation, exhaled nitric oxide (NO and adenosine monophosphate (AMP provocative challenge. The aim was to assess the onset of the anti-inflammatory action of low and high doses and evaluate the suitability of non-invasive assessments to demonstrate dose response. Methods Steroid naïve adult out-patients with mild asthma, sensitive to AMP with baseline exhaled NO > 25 parts per billion entered a double-blind, placebo-controlled, 3-way, cross-over study. Patients were randomised to low dose (1 actuation or high dose (4 actuations extrafine BDP/F 100/6 μg, or placebo administered twice daily on Days 1 and 2 and once in the morning on Day 3 of each period. Exhaled NO was measured pre-dose on Day 1, then 2 and 4 hours post-administration on Day 3. The AMP challenge was performed 4 hours post-administration on Day 3 and forced expiratory volume in 1 second (FEV1, L was measured from 0 to 4 hours post-dose on Day 1. Endpoints were NO at 2 and 4 hours, AMP challenge at 4 hours after the fifth dose on Day 3 and FEV1 area under the curve from 0 to 4 h post-dose on Day 1. Analysis of covariance was performed for NO and FEV1 and analysis of variance for AMP challenge. Results Eighteen patients were randomised and completed the study. Exhaled NO was significantly lower for both doses of extrafine BDP/F versus placebo at 2 and 4 hours (high dose LS mean difference: -22.5 ppb, p 1 was significantly improved versus placebo for both doses (high dose LS mean difference: 0.2 L, p = 0.0001; low dose: 0.2 L p = 0.0001, but without a significant dose response. Conclusions The fixed combination inhaler of extrafine BDP/F has early dose-dependent anti-inflammatory effects with a rapid onset of bronchodilatation in mild asthmatic patients. Trial Registration

  2. Long-term safety of Mometasone Furoate administered via a dry powder inhaler in children: Results of an open-label study comparing Mometasone Furoate with Beclomethasone Dipropionate in children with persistent asthma

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    Corren Jonathan

    2009-07-01

    Full Text Available Abstract Background To assess the long-term pediatric safety of 2 doses of mometasone furoate administered via a dry powder inhaler (MF-DPI for mild-to-moderate persistent asthma and compare them with that of beclomethasone dipropionate administered via a metered dose inhaler (BDP-MDI in the treatment of persistent asthma. Both MF-DPI doses tested are twice the approved pediatric dosage of 100 μg once-daily (QD for children aged 4–11 years. Methods Children (N = 233 aged 4–11 years were randomized to 52 weeks of treatment with MF-DPI 200 μg QD AM, MF-DPI 100 μg twice daily (BID, or BDP-MDI 168 μg BID. Patients had used inhaled corticosteroids (ICSs daily for ≥ 30 days before the screening visit and were on stable ICS doses for ≥ 2 weeks before screening. The primary safety variable was the incidence of adverse events. Secondary safety variables were laboratory tests (including cortisol concentrations, vital signs, and physical examination. Results The incidence of adverse events was similar in all 3 treatment groups. The most frequently reported adverse event was upper respiratory tract infection, reported by 47%–49% of the MF-DPI-treated patients and 51% of the BPD-treated patients. Most adverse events were considered unrelated to study drug. The most frequently reported related adverse events were headache (MF-DPI 200 μg QD AM, 8%; MF-DPI 100 μg BID, 4%; BDP-MDI 168 μg BID, 2% and oral candidiasis (4% in each treatment group. No clinically relevant changes in laboratory values, including plasma cortisol, vital signs, or physical examinations were noted in any treatment group. Conclusion Both MF-DPI doses were well tolerated, with no unusual or unexpected adverse events or safety concerns, and had a similar adverse event profile to that of BDP-MDI 168 μg BID.

  3. T型微通道内丙酸倍氯米松纳米颗粒的制备%Preparation of beclomethasone dipropionate nanoparticles in T-junction microreactor

    Institute of Scientific and Technical Information of China (English)

    张乾霞; 崔改静; 周月; 娄金婷; 王洁欣

    2011-01-01

    @@ 引言 干粉吸入剂是将一种或多种药物制成一定范围的微小颗粒,经特殊的给药装置使药物以粉雾状进入呼吸道和肺部,发挥局部或全身的作用.影响吸人的因素主要有粒径大小、形态、分散性和吸湿性等特性,其中药物的粒径大小和分布是影响DPI肺部沉积率的重要因素[1-2].因此,药物纳米化是干粉吸入剂取得成功的一大关键.目前,多采用的药物纳米化技术为机械粉碎(如球磨、气流粉碎),制备的产品粒度分布宽、能耗大、效率低、易使热不稳定药物的结构破坏或降解等[3].而相对于传统的机械纳米化过程,液相沉淀法显示了更好的可控性,并且由于其操作简单、弹性大、设备投资小,而成为制备纳米药物颗粒的主要方法之一[4].%As model drug, beclomethasone dipropionate (BDP) nanoparticles were prepared by using the antisolvent precipitation method in a T-junction microchannel. The influence of surfactant on particle morphology, as well as the influences of surfactant concentration, BDP solution flow rate, antisolvent flow rate, BDP solution concentration and precipitation temperature on particle size were explored. The results indicated that the morphology of BDP was spherical with the addition of surfactant (HPMC). Besides, the particle size decreased with decreasing BDP solution flow rate, increasing antisolvent flow rate and decreasing precipitation temperature. However, with the increase of BDP concentration, particle size reached a minimum. BDP nanoparticles with an average size of 200-260 nm and narrow size distribution could be prepared under the following conditions: BDP solution flow rate of 4 ml· min-1, antisolvent flow rate of 80 ml · min-1 , solution concentration of 0.03 g · ml-1. Furthermore, crude BDP and nanosized BDP were characterized by scanning electronic microscopy (SEM), X-ray diffraction (XRD), Fourier transform infrared spectrophotometry (FTIR), and

  4. Efeitos da inalação de beclometasona e furosemida sobre a função pulmonar e índice de oxigenação de recém-nascidos prematuros Efectos de la inhalación de beclometasona y furosemida sobre la función pulmonar e índice de oxigenación de recién nacidos prematuros Inhalation effects of beclomethasone and furosemide on pulmonary function and oxygenation index of preterm newborns

    Directory of Open Access Journals (Sweden)

    Leila Simone Foerster

    2013-03-01

    Full Text Available O objetivo deste estudo foi avaliar a função pulmonar e o índice de oxigenação de recém-nascidos pré-termo submetidos à inalação endotraqueal de beclometasona e furosemida. Foram avaliados 30 recém-nascidos pré-termo com idade gestacional El objetivo de este estudio fue evaluar la función pulmonar e índice de oxigenación de recién nacidos de pre-término sometidos a la inhalación endotraqueal de beclometasona y furosemida. Fueron evaluados 30 recién nacidos de pre-término con edad gestacional The objective of this study was to evaluate lung function and oxygenation index of preterm infants undergoing endotracheal inhaling of beclomethasone and furosemide. We studied 30 newborn preterms with gestational age <36 weeks, undergoing conventional mechanical ventilation for at least 12 hours. Three sequential inhalations with their medications were executed with an interval of three hours between each. We collected samples of arterial blood for gas analysis, and after endotracheal aspiration, the measurement of respiratory variables was performed in two stages, two hours before and after the last inhalation. Dynamic compliance and the oxygenation index showed no statistically significant difference between before and after the medication, however, the airway resistance group demonstrated a reduction in beclomethasone between the moments before and after the intervention (p=0.03. These results cannot imply that inhaled beclomethasone and furosemide exerted significant influence on lung function and oxygenation in the newborn infants studied.

  5. Avaliação da eficácia clínica, aceitabilidade e preferência de dois sistemas inalatórios de beclometasona no tratamento da asma: Pulvinal® versus Aeroliser® Acceptability, preference, tolerance and clinical efficacy of beclomethasone delivered by two inhalation devices in chronic asthma patients: Clenil pulvinal® versus Miflasona Aerolizer®

    Directory of Open Access Journals (Sweden)

    Jussara Fiterman

    2004-10-01

    could increase treatment compliance. OBJECTIVE: To compare the acceptability of and preference for two inhalation devices (Pulvinal and Aerolizer, as well as to evaluate the efficacy of and tolerance for beclomethasone dipropionate when delivered by these two systems. METHOD: A multicenter, randomized, crossover parallel study was carried out involving 83 patients with stable asthma. Patients received 500-1000 mg/day of beclomethasone dipropionate. After a 2-week run in, the patients were randomized to begin a 4-week crossover treatment period with equivalent doses of Clenil Pulvinal (CP or Miflasona Aerolizer (MA. RESULTS: Both groups showed improvement in dyspnea and FEV1, and acceptability was considered good or excellent in both groups. Of the patients studied, 50.6% preferred CP, and 39% preferred MA. In their future treatment regimes, 54.5% would choose the CP and 37.7% the MA. CONCLUSION: Clinical efficacy and acceptability were comparable between CP and MA.

  6. Solubilization of beclomethasone dipropionate in sterically stabilized phospholipid nanomicelles (SSMs): physicochemical and in vitro evaluations

    OpenAIRE

    Peh KK; Darwis Y; Abdulameer SA; Sahib MN; Tan YT

    2012-01-01

    Mohanad Naji Sahib, Shaymaa Abdalwahed Abdulameer, Yusrida Darwis, Kok Khiang Peh, Yvonne Tze Fung TanSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, MalaysiaBackground: The local treatment of lung disorders such as asthma and chronic obstructive pulmonary disease via pulmonary drug delivery offers many advantages over oral or intravenous routes of administration. This is because direct deposition of a drug at the diseased site increases local drug concentrations, which ...

  7. Pharmacokinetic Comparison of Inhaled Fixed Combination vs. the Free Combination of Beclomethasone and Formoterol pMDIs in Asthmatic Children

    DEFF Research Database (Denmark)

    Chawes, Bl; Piccinno, A; Kreiner-Møller, Eskil;

    2012-01-01

    /mL) ratio Test/Reference 0.97 [0.85-1.10]. All pharmacokinetic and pharmacodynamic endpoints showed non-superiority in favour of the Test drug. One adverse event (vertigo) occurred but was not considered treatment-related. CONCLUSION: BDP and Formoterol pharmacokinetic and pharmacodynamic effects are non...

  8. A comparison of the effects of sodium cromoglycate and beclomethasone dipropionate on pulmonary function and bronchial hyperreactivity in subjects with asthma

    DEFF Research Database (Denmark)

    Svendsen, U G; Frølund, L; Madsen, F; Nielsen, N H; Holstein-Rathlou, N H; Weeke, B

    1987-01-01

    After a run-in period of 2 weeks, receiving a regimen of inhaled beta 2-agonists and/or theophyllines, 38 atopic patients with asthma with perennial symptoms were randomly allocated to receive an 8-week treatment of additional inhalation treatment with either sodium cromoglycate (SCG), 2 mg four...

  9. Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

    Science.gov (United States)

    2015-03-05

    Hematopoietic/Lymphoid Cancer; Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Atypical Chronic Myeloid Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Childhood Chronic Myelogenous Leukemia; Childhood Myelodysplastic Syndromes; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Contiguous Stage II Adult Lymphoblastic Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; de Novo Myelodysplastic Syndromes; Essential Thrombocythemia; Extramedullary Plasmacytoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Graft Versus Host Disease; Isolated Plasmacytoma of Bone; Juvenile Myelomonocytic Leukemia; Meningeal Chronic Myelogenous Leukemia; Myelodysplastic/Myeloproliferative Disease, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Myelodysplastic Syndromes; Stage I Adult Burkitt Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage I Adult Diffuse Mixed Cell Lymphoma; Stage I Adult Diffuse Small Cleaved Cell Lymphoma; Stage I Adult Hodgkin Lymphoma; Stage I Adult Immunoblastic Large Cell Lymphoma; Stage I Adult Lymphoblastic Lymphoma; Stage I Adult T-cell Leukemia/Lymphoma; Stage I Childhood Hodgkin Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage I Mantle Cell Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage I Small Lymphocytic Lymphoma; Stage II Adult Hodgkin Lymphoma; Stage II Adult T-cell Leukemia/Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Multiple Myeloma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Multiple Myeloma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma

  10. Optimization of solid phase extraction clean up and validation of quantitative determination of corticosteroids in urine by liquid chromatography-tandem mass spectrometry

    DEFF Research Database (Denmark)

    Andersen, Jens Hinge; Hansen, Lene Gram; Pedersen, Mikael

    -glucuronidase/aryl sulfatase. For the final method, which included fluocinolone acetonid, triamcinolone acetonid, beclomethasone, flumethasone, dexamethasone, betamethasone, 6α-methylprednisolone, prednisone and prednisolone, a quantification based on spiked samples carried through the entire analytical procedure was used...

  11. Effects of topical administration of beclomethazone dipropionate on the symptoms of chronic rhinitis

    OpenAIRE

    Ursulović Dejan D.; Janošević Ljiljana B.; Janošević Slobodanka B.; Đukić Vojko

    2003-01-01

    The aim of this study was to evaluate the effect of topical administration of corticosteroid beclomethasone dipropionate on common nasal symptoms in moderate allergic and non-allergic hyperreactive eosinophilic rhinitis, and in allergic and non-allergic hyperreactive eosinophilic rhinitis associated with bilateral moderate nasal polyposis. The study was prospective and controlled. During the study 106 patients were examined, out of whom 66 were treated, while 40 had no therapy. Beclomethasone...

  12. Avaliação da eficácia clínica, aceitabilidade e preferência de dois sistemas inalatórios de beclometasona no tratamento da asma: Pulvinal® versus Aeroliser® Acceptability, preference, tolerance and clinical efficacy of beclomethasone delivered by two inhalation devices in chronic asthma patients: Clenil pulvinal® versus Miflasona Aerolizer®

    OpenAIRE

    Jussara Fiterman; Waldo Mattos; Alberto Cukier; Márcia Pizzichinni; Rodnei Frare e Silva; Fabiane Kahan; José Roberto Jardim; Armando Brancatelli

    2004-01-01

    INTRODUÇÃO: Apenas metade dos pacientes asmáticos fazem o tratamento prescrito, o que torna a baixa adesão ao tratamento um dos principais problemas no manejo desta enfermidade. É possível que dispositivos inalatórios que combinem o melhoramento tecnológico com a simplicidade e o conforto em sua utilização possam minimizar a baixa adesão ao tratamento. OBJETIVO: Comparar a aceitabilidade e preferência de dois dispositivos inalatórios para a administração de beclometasona: Clenil Pulvinal(P) e...

  13. 11.3.Upper respiratory tract disease and bronchial asthma

    Institute of Scientific and Technical Information of China (English)

    1992-01-01

    920096 A clinical trial of treating asthma ofmoderate severity with beclomethason dip-ropionate aerosol.SHEN Xun (沈勋),et al.DeptPulmon Med,Zhongshan Hosp,Shanghai MedUniv,200032.Chin J Intern Med 1991; 30 (9):536-538.In order to investigate the efficacy of steroidinhalation in treating asthma of moderate sever-

  14. Efeitos da inalação de beclometasona e furosemida sobre a função pulmonar e índice de oxigenação de recém-nascidos prematuros Efectos de la inhalación de beclometasona y furosemida sobre la función pulmonar e índice de oxigenación de recién nacidos prematuros Inhalation effects of beclomethasone and furosemide on pulmonary function and oxygenation index of preterm newborns

    OpenAIRE

    Leila Simone Foerster; Paula Cristhina Niz Xavier; Durval Batista Palhares

    2013-01-01

    O objetivo deste estudo foi avaliar a função pulmonar e o índice de oxigenação de recém-nascidos pré-termo submetidos à inalação endotraqueal de beclometasona e furosemida. Foram avaliados 30 recém-nascidos pré-termo com idade gestacional

  15. Lung penetration and patient adherence considerations in the management of asthma: role of extra-fine formulations

    Directory of Open Access Journals (Sweden)

    Scichilone N

    2013-03-01

    Full Text Available Corrigendum Scichilone N, Spatafora M, Battaglia S, Arrigo R, Benfante A, Bellia V. J Asthma Allergy. 2013;6:11–21.On page 15, the note in the legend for Figure 3 was incorrectly listed as "The improvement is greater in the extra-fine beclomethasone-formoterol combination group than in the non-extra-fine fluticasone propionate-formoterol group". The correct sentence is "The improvement is greater in the extra-fine beclomethasone-formoterol combination group than in the non-extra-fine fluticasone propionate-salmeterol group".On page 16, there is a missing note for Figure 4. Note: Data on file. (Chiesi Farmaceutici S.p.A, 2012Read the original article

  16. The use of cultures and immunologic procedures to predict oropharyngeal candidiasis in patients on steroid aerosols.

    Science.gov (United States)

    Spector, S L; Wangaard, C; Bardana, E J

    1982-05-01

    Sixty-seven asthmatic individuals treated with either beclomethasone diproprionate or flunisolide were sequentially evaluated for up to 32 months to determine the incidence of oropharyngeal candidiasis as well as laboratory parameters which might be predictive of this complication. Throat cultures and measurements of Candida antibody by immunodiffusion and radioimmunoassay were performed and compared over time and treatment groups. Unlike other studies, pre-treatment Candida precipitins did not predict increased risk for clinical thrush nor did quantitative determinations of Candida antibody. Those patients with positive cultures pre-trial, however, had a significantly higher incidence of clinical thrush than those with negative cultures (P less than 0.01). No significant changes occurred over time or between drugs for any of the parameters. Symptomatic thrush, however, was slightly more common in those patients treated with beclomethasone. PMID:7105391

  17. Inhaled steroid/tobacco smoke particle interactions: a new light on steroid resistance

    OpenAIRE

    Nicolini Gabriele; Mazza Roberto; De Marco Cinzia; Ruprecht Ario; Invernizzi Giovanni; Boffi Roberto

    2009-01-01

    Abstract Background Inhaled steroid resistance is an obstacle to asthma control in asthmatic smokers. The reasons of this phenomenon are not yet entirely understood. Interaction of drug particles with environmental tobacco smoke (ETS) could change the aerodynamic profile of the drug through the particle coagulation phenomenon. Aim of the present study was to examine whether steroid particles interact with smoke when delivered in the presence of ETS. Methods Beclomethasone-hydrofluoralkane (BD...

  18. Severe Oro-laryngeal Thrush Following Excessive Use of Steroid Inhaler

    OpenAIRE

    Marina, MB; Ramli, R.; Primuharsa Putra, SHA

    2010-01-01

    Inhaled steroids such as fluticasone propionate and beclomethasone dipropionate play an important role in the treatment of bronchial asthma. Its usage facilitates disease control in asthmatic patients, resulting in improved quality of life. Because of its benefit, the inhaled steroid is used extensively, at higher doses and for longer duration. However, the localized effects of inhaled corticosteroids on oral/laryngeal mucosa, such as fungal infections can be problematic. Case Report: We repo...

  19. A self management plan in the treatment of adult asthma.

    OpenAIRE

    Beasley, R; Cushley, M; Holgate, S T

    1989-01-01

    To determine whether routine assessment of peak expiratory flow (PEF) in association with a self management plan based on inhaled corticosteroid use is effective in the management of chronic asthma, 36 consecutive adult patients with asthma attending an outpatient chest clinic were admitted to an open prospective study. Patients were treated with inhaled salbutamol and beclomethasone dipropionate in an attempt to achieve normal lung function. Each patient had a "potential normal value," which...

  20. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

    OpenAIRE

    Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.

    2011-01-01

    BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...

  1. Long term (5 Year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    OpenAIRE

    Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.

    2011-01-01

    Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...

  2. Inhalative versus oral prophylaxis of pneumonitis in patients receiving thoracic irradiation

    International Nuclear Information System (INIS)

    Fifty-seven patients receiving thoracic irradiation for bronchial carcinoma were assigned to 2 therapeutic groups; half of the patients were given 10 mg of oral prednisolone per day, while the other half received daily inhalative beclomethasone. All patients were evaluated for radiographic signs of pneumonitis. Thirty-two patients received additional investigations for pulmonary diffusion capacity of carbonmonoxide. The overall incidence of pneumonitis was 17.6% (10/57 patients). Neither total radiation dose nor mode of fractionation did significantly contribute to the incidence of pneumonitis. Those patients showing a pulmonary diffusion capacity for carbonmonoxide of less than 60% prior to radiotherapy had a significantly higher risk of developing pneumonitis (4/7) than patients with a higher diffusion capacity (3/25, p=0.026). In the follow-up period we did not see significant changes in diffusion capacity neither with patients who developed pneumonitis nor with those patients showing no evidence of pulmonary injury. Comparing the chest X-rays there were less radiographic changes consistent with pneumonitis in the inhalative beclomethasone (2/28) than in the oral prednisolone group (8/29, p=0.045). In order to reduce the incidence of pneumonitis in patients receiving thoracic irradiation we support a continuous application of steroids in the course of and following radiotherapy. The inhalative use of beclomethasone has proved to be superior to oral prednisolone due to better local efficacy and decreased unwanted side effects. (orig./MG)

  3. Autoradiographic studies on percutaneous absorption of flumethasone-pivalate

    International Nuclear Information System (INIS)

    The distribution of topically applied radioactive flumethasone-pivalate was studied by means of autoradiography (direct mounting method). This substance was deposited in horny and Malpighian layers of epidermis and skin appendages (hair follicle, sebaceous gland and apocrine gland) more densely than in epidermis. This distribution pattern was discussed in comparison with the distribution patterns of the previously studied topical corticosteroids, namely, hydrocortisone, hydrocortisone-17-butyrate, triamcinolone-acetonide, betamethasone-17-valerate, 17-α-desoxymethasone, fluocinolone-acetonide and beclomethasone-dipropionate. (auth.)

  4. Drug permeation and cellular interaction of amino acid-coated drug combination powders for pulmonary delivery.

    Science.gov (United States)

    Vartiainen, Ville; Bimbo, Luis M; Hirvonen, Jouni; Kauppinen, Esko I; Raula, Janne

    2016-05-17

    The effect of three amino acid coatings (l-leucine, l-valine and l-phenylalanine) on particle integrity, aerosolization properties, cellular interaction, cytocompatibility, and drug permeation properties of drug combination powder particles (beclomethasone dipropionate and salbutamol sulphate) for dry powder inhalation (DPI) was investigated. Particles with crystalline l-leucine coating resulted in intact separated particles, with crystalline l-valine coating in slightly sintered particles and with amorphous l-phenylalanine coating in strongly fused particles. The permeation of beclomethasone dipropionate across a Calu-3 differentiated cell monolayer was increased when compared with its physical mixture. Drug crystal formation was also observed on the Calu-3 cell monolayer. The l-leucine coated particles were further investigated for cytocompatibility in three human pulmonary (Calu-3, A549 and BEAS-2B) and one human macrophage (THP-1) cell lines, where they showed excellent tolerability. The l-leucine coated particles were also examined for their ability to elicit reactive oxygen species in pulmonary BEAS-2B and macrophage THP-1 cell lines. The study showed the influence of the amino acid coatings for particle formation and performance and their feasibility for combination therapy for pulmonary delivery. PMID:27034001

  5. Inhaled corticosteroids for abnormal pulmonary function in children with a history of Chronic Lung Disease of Infancy: study protocol [ISRCTN55153521

    Directory of Open Access Journals (Sweden)

    Sauve Reginald

    2005-04-01

    Full Text Available Abstract Background There is considerable evidence from the literature that children with chronic lung disease of infancy (CLD have abnormal pulmonary function in childhood and this could have an impact on their life quality and overall health. There are similarities between CLD and asthma, and corticosteroids are the mainstay treatment for asthma. Many physicians use inhaled corticosteroids in children with CLD with no evidence. Therefore we wish to conduct a randomized double-blinded placebo controlled trial to test for the role of inhaled corticosteroids in children aged from3 to 9 years with a history of CLD. Our primary hypothesis will be that inhaled corticosteroids are beneficial in children with CLD. Methods Our primary hypothesis is that using inhaled steroids; Beclomethasone Dipropionate (QVAR 100 mcg 2 puffs 2 times a day for 6 weeks will improve the respiratory system resistance and the quality of life in children with CLD. Discussion We propose that Beclomethasone Dipropionate (QVAR will affect the pulmonary function after 6 weeks of treatment. In summary we think that our study will highlight knowledge on whether the use of inhaled steroids is clinically effective for CLD.

  6. Oral and inhaled corticosteroids: Differences in P-glycoprotein (ABCB1) mediated efflux

    International Nuclear Information System (INIS)

    There is concern that P-glycoprotein mediated efflux contributes to steroid resistance. Therefore, this study examined bidirectional corticosteroid transport and induction capabilities for P-glycoprotein (P-gp) to understand which of the systemic and inhaled corticosteroids interacted with P-gp to the greatest extent. Hydrocortisone, prednisolone, prednisone, methylprednisolone, and dexamethasone represented systemically active drugs, while fluticasone propionate, beclomethasone dipropionate, ciclesonide and budesonide represented inhaled corticosteroids. Aldosterone and fludrocortisone represented mineralocorticoids. All drugs were detected using individually optimised HPLC protocols. Transport studies were conducted through Caco-2 monolayers. Hydrocortisone and aldosterone had efflux ratios below 1.5, while prednisone showed a P-gp mediated efflux ratio of only 1.8 compared to its active drug, prednisolone, with an efflux ratio of 4.5. Dexamethasone and beclomethasone had efflux ratios of 2.1 and 3.3 respectively, while this increased to 5.1 for methylprednisolone. Fluticasone showed an efflux ratio of 2.3. Protein expression studies suggested that all of the inhaled corticosteroids were able to induce P-gp expression, from 1.6 to 2 times control levels. Most of the systemic corticosteroids had higher passive permeability (> 20 × 10−6 cm/s) compared to the inhaled corticosteroids (> 5 × 10−6 cm/s), except for budesonide, with permeability similar to the systemic corticosteroids. Inhaled corticosteroids are not transported by P-gp to the same extent as systemic corticosteroids. However, they are able to induce P-gp production. Thus, inhaled corticosteroids may have greater interactions with other P-gp substrates, but P-gp itself is less likely to influence resistance to the drugs. -- Highlights: ► Inhaled corticosteroids are only weak substrates for P-gp, including budesonide. ► Inhaled corticosteroid potent P-gp inducers especially fluticasone and

  7. Hidrofluoralcano como propelente dos aerossóis pressurizados de dose medida: histórico, deposição pulmonar, farmacocinética, eficácia e segurança Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics, efficacy and safety

    Directory of Open Access Journals (Sweden)

    Cássio C. Ibiapina

    2004-12-01

    Full Text Available OBJETIVO: Rever a literatura sobre o hidrofluoralcano como propelente dos inaladores de dose medida contendo medicamentos empregados na asma. FONTES DOS DADOS: O levantamento bibliográfico foi realizado em bancos de dados eletrônicos - MEDLINE, MDConsult, HighWire, Medscape e LILACS - e por pesquisa direta - referentes aos últimos 15 anos -, utilizando-se as seguintes palavras-chaves: hidrofluoralcano, asma e infância. SÍNTESE DOS DADOS: Foram selecionados 43 artigos originais abordando a questão da substituição do clorofluorcarbono pelo hidrofluoralcano. Este gás mostrou-se como uma alternativa de propelente segura, com deposição pulmonar de 50 a 60% e eficácia significativa quando comparado com placebo (p OBJECTIVE: To review the literature about hydrofluoroalkane as a propellent of pressurized metered-dose inhalers containing anti-asthma drugs. SOURCES OF DATA: Bibliographic search in electronic databases (MEDLINE, MDConsult, HighWire, Medscape and LILACS and direct search referring to the past 15 years, using the key words hydrofluoroalkane, asthma and childhood were carried out. SUMMARY OF THE FINDINGS: 43 original articles on the replacement of clorofluorcarbon by hydrofluoralkane were selected. Hydrofluoralkane showed to be a safe propellent, with pulmonary deposition ranging from 50 to 60%, and to have significant efficacy, when compared with placebo (p < 0.003 in controlled clinical trials. Most works using hydrofluoralkane included beclomethasone diproprionate. Approximate annual cost of a treatment with beclomethasone diproprionate/hydrofluoralkane was lower than with beclomethasone diproprionate/clorofluorcarbon. Some studies assessed salbutamol, fluticasone, flunisolide and the association fluticasone-salmeterol, with hydrofluoralkane as propellent in pressurized metered-dose inhalers. CONCLUSIONS: Efficacy and safety of hydrofluoralkane as propellent of bronchodilators and inhaled corticosteroids in adults was evidenced

  8. Oral and inhaled corticosteroids: Differences in P-glycoprotein (ABCB1) mediated efflux

    Energy Technology Data Exchange (ETDEWEB)

    Crowe, Andrew, E-mail: a.p.crowe@curtin.edu.au; Tan, Ai May

    2012-05-01

    There is concern that P-glycoprotein mediated efflux contributes to steroid resistance. Therefore, this study examined bidirectional corticosteroid transport and induction capabilities for P-glycoprotein (P-gp) to understand which of the systemic and inhaled corticosteroids interacted with P-gp to the greatest extent. Hydrocortisone, prednisolone, prednisone, methylprednisolone, and dexamethasone represented systemically active drugs, while fluticasone propionate, beclomethasone dipropionate, ciclesonide and budesonide represented inhaled corticosteroids. Aldosterone and fludrocortisone represented mineralocorticoids. All drugs were detected using individually optimised HPLC protocols. Transport studies were conducted through Caco-2 monolayers. Hydrocortisone and aldosterone had efflux ratios below 1.5, while prednisone showed a P-gp mediated efflux ratio of only 1.8 compared to its active drug, prednisolone, with an efflux ratio of 4.5. Dexamethasone and beclomethasone had efflux ratios of 2.1 and 3.3 respectively, while this increased to 5.1 for methylprednisolone. Fluticasone showed an efflux ratio of 2.3. Protein expression studies suggested that all of the inhaled corticosteroids were able to induce P-gp expression, from 1.6 to 2 times control levels. Most of the systemic corticosteroids had higher passive permeability (> 20 × 10{sup −6} cm/s) compared to the inhaled corticosteroids (> 5 × 10{sup −6} cm/s), except for budesonide, with permeability similar to the systemic corticosteroids. Inhaled corticosteroids are not transported by P-gp to the same extent as systemic corticosteroids. However, they are able to induce P-gp production. Thus, inhaled corticosteroids may have greater interactions with other P-gp substrates, but P-gp itself is less likely to influence resistance to the drugs. -- Highlights: ► Inhaled corticosteroids are only weak substrates for P-gp, including budesonide. ► Inhaled corticosteroid potent P-gp inducers especially

  9. Complications associated with brachytherapy alone or with laser in lung cancer

    International Nuclear Information System (INIS)

    Relatively little has been reported about destruction through brachytherapy of mucosa-perforating and extraluminary tumors with probable large vessel involvement causing major hemorrhagic or fistular complications. We report 12 patients subjected to laser and brachytherapy for centrally occluding lung cancer, whom we have periodically followed up from June 1986 until they died. Although all laser procedures were free from complications, necrotic cavitation in five cases, two of which were accompanied by large bronchoesophageal fistulas, and massive fatal hemoptysis occurred in six. Minor complications included radiation mucositis (two), noncritical mucosal scarring (two), and cough (four). Characteristics that will identify patients at risk of developing fatal hemoptysis and fistulas should be better defined by imaging and endoscopic techniques. In such cases, modifying the protocol or using alternative procedures should be considered. Minor complications, such as cough, can be avoided by using topical steroid therapy (eg, beclomethasone dipropionate)

  10. Knemometry, urine cortisol excretion, and measures of the insulin-like growth factor axis and collagen turnover in children treated with inhaled glucocorticosteroids

    DEFF Research Database (Denmark)

    Wolthers, O D; Hansen, M; Juul, A;

    1997-01-01

    Correlations between knemometric (lower leg length) growth rates and urine free cortisol excretion, respectively, and serum concentrations of IGF-I, IGF binding protein-3, osteocalcin, carboxy terminal propeptide of type I collagen (PICP), carboxy terminal pryridinoline cross-linked telopeptide of...... study was a double blind, crossover trial with three active treatment periods and two wash-out periods. All periods were 15 d long. Overnight urine free cortisol/ creatinine x 10(6) did not correlate with knemometric growth rates or any of the serum markers. Significant correlations (Pearson......'s correlation coefficient, P) between knemometric growth rates and IGF-I (0.41; 0.006), IGFBP-3 (0.35; 0.02), PICP (0.44; 0.003), ICTP (0.35; 0.001), and PIIINP (0.46; 0.002) were found. Compared with fluticasone propionate, 200 micrograms, beclomethasone dipropionate, 400 and 800 micrograms, caused significant...

  11. [A new spacer, Babyhaler, for BDP inhalation therapy in severe infantile asthma].

    Science.gov (United States)

    Yamada, Y; Yoshihara, S; Abe, T; Fukuda, N; Watanabe, M; Ono, M; Arisaka, O

    2000-11-01

    Recently, it has been recognized that airway inflammation is the most important pathogenesis of bronchial asthma, and inhaled corticosteroids therapy is effective for childhood asthma. However, using metered dose inhalers (MDI) of beclomethasone dipropionate (BDP) is difficult for infants. In this study, we administered BDP inhalation therapy with a new spacer, Babyhaler, for five cases of early childhood with severe infantile asthma that we could not control even by combination of theophylline round the clock (RTC) therapy and disodium cromoglycate (DSCG) + beta 2 stimulant (beta 2) regular use. We compared symptom score of asthma attack between the pre-treatment period (prior 2 weeks) and post-treatment period (following 8 weeks) of BDP inhalation therapy with Babyhaler. As a result, symptom score decreased significantly within 4 weeks after treatment of BDP with Babyhaler as compared with the score before treatment of BDP. These findings suggest that Babyhaler is useful for BDP inhalation therapy in infantile asthma. PMID:11193463

  12. Realization of polyaspartamide-based nanoparticles and in vivo lung biodistribution evaluation of a loaded glucocorticoid after aerosolization in mice.

    Science.gov (United States)

    Craparo, E F; Di Gioia, S; Trapani, A; Cellamare, S; Belgiovine, G; Mandracchia, D; Giammona, G; Cavallaro, G; Conese, M

    2016-08-20

    In this study, novel polymeric nanoparticles (NPs) were developed and their potential as carriers for beclomethasone dipropionate (BDP) into the lung after aerosolization was demonstrated by in vivo studies in mice. In particular, these NPs were obtained starting from two polyaspartamide-based copolymers which were synthesized by chemical reaction of α,β-poly(N-2-hydroxyethyl)-dl-aspartamide (PHEA) and its pegylated derivative (PHEA-PEG2000) with poly(lactic acid) (PLA). To obtain nanosized particles, the high pressure homogenization (HPH)-solvent evaporation method was followed by using an organic phase containing both PHEA-PLA and PHEA-PEG2000-PLA (at a weight ratio equal to 1:1), lactose as cryoprotectant and no surfactant was adopted. PHEA-PLA/PHEA-PEG2000-PLA NPs were characterized by a quite spherical shape, ζ potential slightly negative, and size lower than 50 and 200nm, respectively, for empty and BDP-loaded NPs. In vivo biodistribution of BDP and its metabolites in various lung compartments, i.e. bronchoalveolar lavage fluid (BALF), alveolar macrophages (MPG) obtained from BALF, and lung tissue, was carried out at 3h post-administration in mice by aerosolization of BDP-loaded NPs or free BDP (commercial formulation, Clenil(®)) at the dose of 0.5mg/kg BDP. Results demonstrated that BDP entrapped into NPs reached all analyzed lung compartments and were internalized by both alveolar MPG and respiratory epithelial cells, and detected amounts were comparable to those of Clenil-treated mice. Moreover, the entrapment into NPs protects the drug from the enzymatic hydrolysis, allowing a significant lower amount of beclomethasone (BOH) into the lung tissue and BALF than that obtained after Clenil administration. PMID:27326484

  13. [The influence of treatment with formoterol, formoterol with tiotropium, formoterol with inhaled glucocorticosteroid and tiotropium on lung functions, tolerance of exercise and simple, morning everyday activities in patients with chronic obstructive pulmonary disease (COPD)].

    Science.gov (United States)

    Szmidt, Mirosław

    2012-01-01

    Bronchodilators - long-acting b2-adrenergic agonists (formoterol and salmeterol) and a long-acting antimuscarinic drug (tiotropium), are the main drugs applied in symptomatic treatment of COPD. In patients with COPD, dyspnea is frequently associated with simple everyday activities. Two questionnaires have been published recently as a means of assessing the patients' ability to perform morning activities and symptoms. Dynamic hyperinflation is the pathophysiological disorder responsible for dyspnea and decreased exercise tolerance in COPD. Formoterol is faster than salmeterol in diminishing air-trapping. It has been shown that treatment with formoterol and tiotropium in COPD patients improves FEV(1), FVC, IC, symptoms score and quality of life in comparison with tiotropium applied alone. Among LABA and inhaled glucocorticosteroids combinations, those containing formoterol have a more beneficial effect on the ability to perform simple morning activities (budesonide/formoterol was better than fluticasone/salmeterol). Beclomethasone/formoterol - 400/24 mcg/die, in comparison with fluticasone/salmeterol - 500/100 mcg/die significantly reduced air-trapping and dyspnea in COPD patients. The comparison of budesonide/formoterol - 400/12 mcg 2 x die with beclomethasone/ /formoterol - 200/12 mcg 2 x die has shown similar influence of both combinations on FEV(1), dyspnea, 6-minute walk test, symptoms score and quality of life. The addition of budesonide and formoterol combination to tiotropium gives further benefits: reduces number of exacerbations, improves FEV1, symptoms score and performance of simple morning routines. Doctors should pay more attention to symptoms and limitations in simple activities in the morning and adequately adjust the treatment. PMID:22562275

  14. Cough Variant Asthma in Medical Outpatient Department of a Tertiary Care Hospital in Bangladesh

    Directory of Open Access Journals (Sweden)

    Rukhsana Parvin

    2013-01-01

    Full Text Available Background: Cough variant asthma (CVA is a subset of asthma where the only symptom is chronic persistent cough. Many cases go unrecognized due to lack of proper evaluation. Response to asthma medication with features supportive of airway hypersensitivity helps in management of this disease. Objective: To find out the proportion of cough variant asthma among the patients attending medicine outpatient department of Enam Medical College, Savar, Dhaka. Materials and Methods: This cross sectional study was conducted in Enam Medical College Hospital, Savar, Dhaka over a period of two years from July 2009 to July 2011. Cough variant asthma was diagnosed mainly on clinical ground as chronic cough without wheezing, fever, weight loss, shortness of breath or sputum or any other apparent cause that persisted for more than eight weeks with absolutely normal physical examination of chest, normal chest radiography and blood count except raised eosinophil count and IgE level. Patients who met these criteria were given 2 weeks course of inhaler beclomethasone propionate and were assessed for improvement. Those who improved after steroid inhalation were categorised as having cough variant asthma. Results: Out of purposively selected 148 patients complaining only of chronic dry cough for more than eight weeks, 92 patients met the primary selection criteria for cough variant asthma. These 92 patients were given 2 weeks trial of 250 ìgm beclomethasone inhalation twice daily. Seventy nine patients reported almost complete recovery from chronic cough after 2 weeks and were categorized as having CVA. Thirteen patients did not improve and were not categorized as CVA. Conclusion: These findings suggest that cough variant asthma is the most common among the patients with chronic cough not due to any apparent cause. The efficacy of inhaled corticosteroid suggests that early intervention is effective in the treatment of this disease.

  15. Impact of extrafine formulations of inhaled corticosteroids/long-acting beta-2 agonist combinations on patient-related outcomes in asthma and COPD

    Directory of Open Access Journals (Sweden)

    Scichilone N

    2014-11-01

    Full Text Available Nicola Scichilone,1 Alida Benfante,1 Luca Morandi,2 Federico Bellini,2 Alberto Papi21Biomedical Department of Internal and Specialist Medicine, Section of Pulmonology, University of Palermo, Italy; 2Respiratory Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, ItalyAbstract: Asthma and chronic obstructive pulmonary disease (COPD are among the most common chronic diseases worldwide, characterized by a condition of variable degree of airway obstruction and chronic airway inflammation. A large body of evidence has demonstrated the importance of small airways as a pharmacological target in these clinical conditions. Despite a deeper understanding of the pathophysiological mechanisms, the epidemiological observations show that a significant proportion of asthmatic and COPD patients have a suboptimal (or lack of control of their diseases. Different factors could influence the effectiveness of inhaled treatment in chronic respiratory diseases: patient-related (eg, aging; disease-related (eg, comorbid conditions; and drug-related/formulation-related factors. The presence of multiple illnesses is common in the elderly patient as a result of two processes: the association between age and incidence of degenerative diseases; and the development over time of complications of the existing diseases. In addition, specific comorbidities may contribute to impair the ability to use inhalers, such as devices for efficient drug delivery in the respiratory system. The inability to reach and treat the peripheral airways may contribute to the lack of efficacy of inhaled treatments. The recent development of inhaled extrafine formulations allows a more uniform distribution of the inhaled treatment throughout the respiratory tree to include the peripheral airways. The beclomethasone/formoterol extrafine formulation is available for the treatment of asthma and COPD. Different biomarkers of peripheral airways are improved by beclomethasone

  16. Mometasone furoate in the management of asthma: a review

    Directory of Open Access Journals (Sweden)

    Ricardo A Tan

    2008-09-01

    Full Text Available Ricardo A Tan1, Jonathan Corren21California Allergy and Asthma Medical Group, Los Angeles, CA; 2Allergy Research Foundation, Los Angeles, CA, USAAbstract: Inhaled corticosteroids (ICS have proven to be the most effective and essential therapy for the treatment of bronchial asthma. The 2007 National Asthma Education and Prevention Program guidelines recommend ICS as preferred therapy for patients with mild to severe persistent asthma. Mometasone furoate (MF is a relatively new ICS agent with high affinity for the glucocorticoid receptor. It is approved in the US for maintenance treatment of asthma for patients 4 years of age and older. It has been shown to be well tolerated with no significant adverse side effects observed in clinical trials and post-marketing surveillance. The efficacy of mometasone furoate has been established in large, well-designed studies. In patients with persistent asthma previously treated either with short-acting beta-agonists alone or twice-daily maintenance therapy with ICS, once-daily MF has been shown to be superior to placebo in improving lung function, symptom control, and quality of life; and has shown comparable efficacy compared with budesonide, beclomethasone, and fluticasone. Twice-daily dosing with MF has been demonstrated to successfully allow for reduction or elimination of oral corticosteroids in severe asthmatics.Keywords: inhaled steroids, mometasone furoate, once-daily dosing, asthma, stepwise approach

  17. A pharmacovigilance study on patients of bronchial asthma in a teaching hospital

    Directory of Open Access Journals (Sweden)

    A N Jamali

    2010-01-01

    Full Text Available Objective : The present study was conducted to monitor adverse drug reactions in patients of bronchial asthma in outpatient department and inpatient department of a university teaching hospital in South Delhi. Materials and Methods : About 200 patients irrespective of age and sex with established asthma were interviewed during the time period of January 2006 to April 2006 using structured questionnaire. Naranjo′s adverse drug reaction probability scale was used to assess the adverse drug reactions. Results : A total of 15 adverse drug reactions were reported in 13 out of 200 asthmatic patients. Among the 13 patients reported with adverse drug reactions, 5 (38.5% were male and 8 (61.5% patients were female. Maximum percentage of ADRs (2 in 15 prescriptions, 13.3% observed with montelukast, followed by beclomethasone (1 in 12 prescriptions, 8.3%, salbutamol (6 in 109 prescriptions, 5.5%, and ipratropium (3 in 63 prescriptions, 4.8%. Conclusions : Montelukast was found to be associated with greater percentage of adverse drug reactions as compared to other antiasthamatics. The above findings are constrained by a small sample size and need to be corroborated by conducting long-term studies using a larger sample size.

  18. Effect of the systemic versus inhalatory administration of synthetic glucocorticoids on the urinary steroid profile as studied by gas chromatography-mass spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Mazzarino, Monica [Laboratorio Antidoping, Federazione Medico Sportiva Italiana, Largo Giulio Onesti 1, 00197 Rome (Italy); Rossi, Francesca [Laboratorio Antidoping, Federazione Medico Sportiva Italiana, Largo Giulio Onesti 1, 00197 Rome (Italy); Giacomelli, Laura [Dipartimento di Scienze Chirurgiche, Universita La Sapienza, Viale Regina Elena 324, 00161 Rome (Italy); Botre, Francesco [Laboratorio Antidoping, Federazione Medico Sportiva Italiana, Largo Giulio Onesti 1, 00197 Rome (Italy) and Dipartimento CGMIA, Universita La Sapienza, Via del Castro Laurenziano 9, 00161 Rome (Italy)]. E-mail: francesco.botre@uniroma1.it

    2006-02-10

    This paper presents a gas chromatography-mass spectrometry (GC-MS) study carried out on human urine to verify whether the administration of glucocorticoids can affect the urinary steroid profile, and especially the levels of endogenous glucocorticoids, androgens and their main metabolites. Betamethasone and beclomethasone, administered either systemically (per os or i.m.) or locally (by inhalation) have been studied. The determination of the urinary levels of endogenous glucocorticoids and androgens was carried out by GC-MS in electron impact ionization mode. Data were evaluated taking into account the baseline individual variability, and compared with values obtained on a control group. Detectable differences were recorded in the steroids metabolites excretion profiles between men and women. The circadian variability of the steroid profile was the same for both sexes, showing a maximum during the morning hours. After systemic treatment with synthetic glucocorticoids, the relative urinary concentrations of corticosteroids, androgens and of their metabolites were significantly altered, recording a transient decrease of the concentration of cortisol and tetrahydrocortisol and a parallel, although less pronounced, increase of the concentration of testosterone, epitestosterone and related androgenic steroids; while no effects were recorded if the administration was by inhalation.

  19. Dispersibility of lactose fines as compared to API in dry powders for inhalation.

    Science.gov (United States)

    Thalberg, Kyrre; Åslund, Simon; Skogevall, Marcus; Andersson, Patrik

    2016-05-17

    This work investigates the dispersion performance of fine lactose particles as function of processing time, and compares it to the API, using Beclomethasone Dipropionate (BDP) as model API. The total load of fine particles is kept constant in the formulations while the proportions of API and lactose fines are varied. Fine particle assessment demonstrates that the lactose fines have higher dispersibility than the API. For standard formulations, processing time has a limited effect on the Fine Particle Fraction (FPF). For formulations containing magnesium stearate (MgSt), FPF of BDP is heavily influenced by processing time, with an initial increase, followed by a decrease at longer mixing times. An equation modeling the observed behavior is presented. Surprisingly, the dispersibility of the lactose fines present in the same formulation remains unaffected by mixing time. Magnesium analysis demonstrates that MgSt is transferred to the fine particles during the mixing process, thus lubrication both BDP and lactose fines, which leads to an increased FPF. Dry particle sizing of the formulations reveals a loss of fine particles at longer mixing times. Incorporation of fine particles into the carrier surfaces is believed to be behind this, and is hence a mechanism of importance as regards the dispersion performance of dry powders for inhalation. PMID:26965200

  20. Determination of betamethasone and betamethasone 17-monopropionate in human plasma by liquid chromatography-positive/negative electrospray ionization tandem mass spectrometry.

    Science.gov (United States)

    Zou, Jian-Jun; Dai, Li; Ding, Li; Xiao, Da-Wei; Bin, Zhu-Yu; Fan, Hong-Wei; Liu, Li; Wang, Guang-Ji

    2008-10-01

    This study presents a high-performance liquid chromatography-positive/negative electrospray ionization tandem mass spectrometric (LC-ESI(+/-)-MS-MS) method for the determination of betamethasone (BOH) and betamethasone 17-monopropionate (B17P) in human plasma using beclomethasone dipropionate as the internal standard (I.S.). Both compounds were extracted from human plasma with ether-cyclohexane (4:1, v/v) and were separated by HPLC on a Hanbon Lichrospher C(18) column with a mobile phase of methanol-water (85:15, v/v) at a flow rate of 0.7ml/min. Calibration curves were linear over the range of 0.10-50ng/ml for BOH and 0.050-50ng/ml for B17P. The inter-run relative standard deviations were less than 14.4% for BOH and 12.3% for B17P. The intra-run relative standard deviations were less than 9.3% for BOH and 7.9% for B17P. The mean plasma extraction recovery for BOH and B17P were in the ranges of 82.7-85.9% and 83.6-85.3%, respectively. The method was successfully applied to study the pharmacokinetics of a new formulation of betamethasone phosphate/betamethasone dipropionate injection in healthy Chinese volunteers. PMID:18757252

  1. Isothermal calorimetry: a predictive tool to model drug-propellant interactions in pressurized metered dose systems.

    Science.gov (United States)

    Ooi, Jesslynn; Gaisford, Simon; Boyd, Ben J; Young, Paul M; Traini, Daniela

    2014-01-30

    The purpose of this work was to evaluate gas perfusion isothermal calorimetry (ITC) as a method to characterize the physicochemical changes of active pharmaceutical ingredients (APIs) intended to be formulated in pressurized metered dose inhalers (pMDIs) after exposure to a model propellant. Spray dried samples of beclomethasone dipropionate (BDP) and salbutamol sulphate (SS) were exposed to controlled quantities of 2H,3H-decafluoropentane (HPFP) to determine whether ITC could be used as a suitable analytical method for gathering data on the behavioural properties of the powders in real time. The crystallization kinetics of BDP and the physiochemical properties of SS were successfully characterized using ITC and supported by a variety of other analytical techniques. Correlations between real and model propellant systems were also established using hydrofluoroalkane (HFA-227) propellant. In summary, ITC was found to be suitable for gathering data on the crystallization kinetics of BDP and SS. In a wider context, this work will have implications on the use of ITC for stability testing of APIs in HFA-based pMDIs. PMID:24325938

  2. Internal exposure dynamics drive the Adverse Outcome Pathways of synthetic glucocorticoids in fish

    Science.gov (United States)

    Margiotta-Casaluci, Luigi; Owen, Stewart F.; Huerta, Belinda; Rodríguez-Mozaz, Sara; Kugathas, Subramanian; Barceló, Damià; Rand-Weaver, Mariann; Sumpter, John P.

    2016-02-01

    The Adverse Outcome Pathway (AOP) framework represents a valuable conceptual tool to systematically integrate existing toxicological knowledge from a mechanistic perspective to facilitate predictions of chemical-induced effects across species. However, its application for decision-making requires the transition from qualitative to quantitative AOP (qAOP). Here we used a fish model and the synthetic glucocorticoid beclomethasone dipropionate (BDP) to investigate the role of chemical-specific properties, pharmacokinetics, and internal exposure dynamics in the development of qAOPs. We generated a qAOP network based on drug plasma concentrations and focused on immunodepression, skin androgenisation, disruption of gluconeogenesis and reproductive performance. We showed that internal exposure dynamics and chemical-specific properties influence the development of qAOPs and their predictive power. Comparing the effects of two different glucocorticoids, we highlight how relatively similar in vitro hazard-based indicators can lead to different in vivo risk. This discrepancy can be predicted by their different uptake potential, pharmacokinetic (PK) and pharmacodynamic (PD) profiles. We recommend that the development phase of qAOPs should include the application of species-species uptake and physiologically-based PK/PD models. This integration will significantly enhance the predictive power, enabling a more accurate assessment of the risk and the reliable transferability of qAOPs across chemicals.

  3. Patient perspectives in the management of asthma: improving patient outcomes through critical selection of treatment options

    Directory of Open Access Journals (Sweden)

    Nicola Scichilone

    2010-02-01

    Full Text Available Nicola Scichilone, Adele Contino, Giovanni Battista Figlioli, Giuseppe Paglino, Vincenzo BelliaDipartimento di Medicina, Pneumologia, Fisiologia e Nutrizione Umana (DIMPEFINU, University of Palermo, Palermo, ItalyAbstract: Asthma is a chronic inflammatory disorder of the airways that requires long-term treatment, the goal of which is to control clinical symptoms for extended periods with the least possible amount of drugs. International guidelines recommend the addition of an inhaled long-acting beta2-agonist (LABA to a low- to medium-dose inhaled corticosteroid (ICS when low doses of ICS fail to control asthma symptoms. The fixed combined administration of ICS/LABA improves patient compliance, reducing the risk of therapy discontinuation. The relative deposition pattern of the inhaled drug to the target site is the result of a complex interaction between the device used, the aerosol formulation and the patient’s adherence to therapy. Different inhalation devices have been introduced in clinical practice over time. The new hydrofluoroalkane (HFA solution aerosols allow for the particle size to be modified, thus leading to deeper penetration of the medication into the lung. The Modulite® technology allows for the manipulation of inhaled HFA-based solution formulations, such as the fixed beclomethasone/formoterol combination, resulting in a uniform treatment of inflammation and bronchoconstriction. The success of any anti-asthmatic treatment depends on the choice of the correct device and the adherence to therapy.Keywords: asthma, therapy, inhalers, compliance

  4. The progress of inhaled corticosteroid/long-actingβ2-agonist combinations in the treatment of asthma%吸入糖皮质激素和长效β2-受体激动剂复方制剂治疗哮喘的研究进展

    Institute of Scientific and Technical Information of China (English)

    孙伟; 揭志军

    2014-01-01

    联合使用吸入糖皮质激素和长效β2-受体激动剂对控制哮喘的气道炎症和改善气道平滑肌功能具有协同和互补作用。吸入糖皮质激素和长效β2-受体激动剂复方制剂是目前哮喘维持治疗的重要药物,主要包括丙酸氟替卡松/沙美特罗、布地奈德/福莫特罗、二丙酸倍氯松/福莫特罗和糠酸莫米松/福莫特罗等。本文就此类复方制剂在哮喘治疗中的临床地位和研究进展作一概述。%Inhaled corticosteroid/long-actingβ2-agonist (ICS/LABA) combinations play synergic and complementary roles in controlling airway inlfammation and improving the function of airway smooth muscle. They are very important drugs for asthma maintenance. The different combinations of ICS/LABA, such as lfuticasone propionate/salmeterol, budesonide/formoterol, beclomethasones dipropionate/formoterol, mometasone furoate/formoterol, have different pharmacological features. This review summarizes the features and progress of these ICS/LABA in the treatment of asthma.

  5. Effect of the systemic versus inhalatory administration of synthetic glucocorticoids on the urinary steroid profile as studied by gas chromatography-mass spectrometry

    International Nuclear Information System (INIS)

    This paper presents a gas chromatography-mass spectrometry (GC-MS) study carried out on human urine to verify whether the administration of glucocorticoids can affect the urinary steroid profile, and especially the levels of endogenous glucocorticoids, androgens and their main metabolites. Betamethasone and beclomethasone, administered either systemically (per os or i.m.) or locally (by inhalation) have been studied. The determination of the urinary levels of endogenous glucocorticoids and androgens was carried out by GC-MS in electron impact ionization mode. Data were evaluated taking into account the baseline individual variability, and compared with values obtained on a control group. Detectable differences were recorded in the steroids metabolites excretion profiles between men and women. The circadian variability of the steroid profile was the same for both sexes, showing a maximum during the morning hours. After systemic treatment with synthetic glucocorticoids, the relative urinary concentrations of corticosteroids, androgens and of their metabolites were significantly altered, recording a transient decrease of the concentration of cortisol and tetrahydrocortisol and a parallel, although less pronounced, increase of the concentration of testosterone, epitestosterone and related androgenic steroids; while no effects were recorded if the administration was by inhalation

  6. Diagnosis and pharmacotherapy of stable chronic obstructive pulmonary disease: the finnish guidelines.

    Science.gov (United States)

    Kankaanranta, Hannu; Harju, Terttu; Kilpeläinen, Maritta; Mazur, Witold; Lehto, Juho T; Katajisto, Milla; Peisa, Timo; Meinander, Tuula; Lehtimäki, Lauri

    2015-04-01

    of an inhaled glucocorticoid and a long-acting β2 -agonist (budesonide-formoterol, beclomethasone dipropionate-formoterol, fluticasone propionate-salmeterol or fluticasone furoate-vilanterol) is recommended as a first choice. Other treatment options for this phenotype include combination of long-acting bronchodilators given from separate inhalers or as a fixed combination (glycopyrronium-indacaterol or umeclidinium-vilanterol) or a triple combination of an inhaled glucocorticoid, a long-acting β2 -agonist and a long-acting anticholinergic. If the patient has severe-to-very severe COPD (FEV1  < 50% predicted), chronic bronchitis and frequent exacerbations despite long-acting bronchodilators, the pharmacotherapy may include also roflumilast. ACOS is a phenotype of COPD in which there are features that comply with both asthma and COPD. Patients belonging to this phenotype have usually been excluded from studies evaluating the effects of drugs both in asthma and in COPD. Thus, evidence-based recommendation of treatment cannot be given. The treatment should cover both diseases. Generally, the therapy should include at least inhaled glucocorticoids (beclomethasone dipropionate, budesonide, ciclesonide, fluticasone furoate, fluticasone propionate or mometasone) combined with a long-acting bronchodilator (β2 -agonist or anticholinergic or both). PMID:25515181

  7. Application of USP inlet extensions to the TSI impactor system 3306/3320 using HFA 227 based solution metered dose inhalers.

    Science.gov (United States)

    Mogalian, Erik; Myrdal, Paul Brian

    2005-12-01

    The objective of this study was to further evaluate the need for a vertical inlet extension when testing solution metered dose inhalers using the TSI Model 3306 Impactor Inlet in conjunction with the TSI Model 3320 Aerodynamic Particle Sizer (APS). The configurations tested using the TSI system were compared to baseline measurements that were performed using the Andersen Mark II 8-stage cascade impactor (ACI). Seven pressurized solution metered dose inhalers were tested using varied concentrations of beclomethasone dipropionate (BDP), ethanol, and HFA 227 propellant. The inhalers were tested with the cascade impactor, and with the TSI system. The TSI system had three different configurations as the manufacturer provided (0 cm) or with inlet extensions of 20 and 40 cm. The extensions were located between the USP inlet and the Model 3306 Impactor Inlet. There were no practical differences between each system for the stem, actuator, or USP inlet. The fine particle mass (aerodynamic mass < 4.7 microm) was affected by extension length and correlated well with the ACI when an extension was present. APS particle size measurements were unaffected by the extension lengths and correlated well to particle size determined from the ACI analysis. It has been confirmed that an inlet extension may be necessary for the TSI system in order to give mass results that correlate to the ACI, especially for formulations having significant concentrations of low volatility excipients. Additionally, the results generated from this study were used to evaluate the product performance of HFA 227 based solution formulations that contain varying concentrations of ethanol as a cosolvent. PMID:16316853

  8. Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extrafine formulation

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    Nicolini Gabriele

    2011-07-01

    Full Text Available Abstract Background Although patients have more problems using metered dose inhalers, clinical comparisons suggest they provide similar control to dry powder inhalers. Using real-life situations this study was designed to evaluate asthma control in outpatients with moderate to severe persistent asthma and to compare efficacy of fixed combinations of inhaled corticosteroids (ICS and long acting beta-agonists (LABA. Methods This real-life study had a cross-sectional design. Patients using fixed combinations of ICS and LABA had their asthma control and spirometry assessed during regular visits. Results 111 patients were analyzed: 53 (47.7% received maintenance therapy of extrafine beclomethasone-formoterol (BDP/F pressurized metered dose inhaler (pMDI, 25 (22.5% fluticasone-salmeterol (FP/S dry powder inhaler (DPI, and 33 (29.7% budesonide-formoterol (BUD/F DPI. Severity of asthma at time of diagnosis, assessed by the treating physician, was comparable among groups. Asthma control was achieved by 45.9% of patients; 38.7% were partially controlled and 15.3% were uncontrolled. In the extrafine BDF/F group, asthma control total score, daytime symptom score and rescue medication use score were significantly better than those using fixed DPI combinations (5.8 ± 6.2 vs. 8.5 ± 6.8; 1.4 ± 1.8 vs. 2.3 ± 2.1; 1.8 ± 2.2 vs. 2.6 ± 2.2; p = 0.0160; p = 0.012 and p = 0.025, respectively and the mean daily ICS dose were significantly lower. Conclusions pMDI extrafine BDP/F combination demonstrated better asthma control compared to DPIs formulated with larger particles. This could be due to the improved lung deposition of the dose or less reliance on the optimal inhalation technique or both.

  9. A reappraisal of the clinical efficacy of nebulized flunisolide in pediatric asthma: the Italian experience.

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    Kantar, Ahmad; Mroueh, Salman; Fiocchi, Alessandro

    2007-01-01

    Flunisolide (FLU) is a synthetic corticosteroid with potent topical anti-inflammatory activity. Its oral bioavailability is poor (6.7%). After gastrointestinal and lung absorption, the drug undergoes rapid and extensive first-pass metabolism by the liver to an inactive 6beta-hydroxylated metabolite. Plasma half-life is estimated to be 3.9 to 4.6 hours. FLU has a low volume of distribution at steady state and a short terminal half-life after inhalation (96 L and 1.6 hour, respectively). FLU, like budesonide, has a short pulmonary residence time and it is hypothesized that it may undergo esterification in the cell due to the presence of a free hydroxyl group at C21. Nebulization may offer important advantages over other inhalation methods. Nebulizers allow drug delivery in very young children through passive inhalation, depending less on patient coordination and cooperation. Comparative studies indicate that FLU is nebulized to a better advantage than beclomethasone dipropionate and budesonide. This is attributed to its elevated water solubility. The aim of this article is to outline the factors that influence drug nebulization and the pharmacokinetics-pharmacodynamics of FLU compared to other inhaled corticosteroids. In addition, we report a series of clinical data regarding the efficacy of nebulized FLU with focus on the Italian experience. Overall, the physicochemical characteristics and pharmacokinetic profile of FLU favor its use for nebulization. Clinical data indicate that nebulized FLU is effective in asthma treatment in infants and children. Side effects were not reported at the commonly used doses. PMID:17883883

  10. The impact of adherence and disease control on resource use and charges in patients with mild asthma managed on inhaled corticosteroid agents

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    P Navaratnam

    2010-06-01

    patients receiving other ICSs, perhaps due to the once-daily dosing of MF. Current NAEPP guidelines recommend low-dose ICS monotherapy for mild persistent asthma; thus, it is critical to optimize mild persistent asthma control and limit unnecessary resource use and charges.Keywords: adherence, asthma control, beclomethasone dipropionate, budesonide, fluticasone propionate, mometasone furoate, retrospective claims analysis

  11. Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler® in Comparison with Diskus® and Turbohaler® Dry Powder Inhalers

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    Buttini, Francesca; Brambilla, Gaetano; Copelli, Diego; Sisti, Viviana; Balducci, Anna Giulia; Bettini, Ruggero; Pasquali, Irene

    2016-01-01

    Abstract Background: European and United States Pharmacopoeia compendial procedures for assessing the in vitro emitted dose and aerodynamic size distribution of a dry powder inhaler require that 4.0 L of air at a pressure drop of 4 kPa be drawn through the inhaler. However, the product performance should be investigated using conditions more representative of what is achievable by the patient population. This work compares the delivered dose and the drug deposition profile at different flow rates (30, 40, 60, and 90 L/min) of Foster NEXThaler® (beclomethasone dipropionate/formoterol fumarate), Seretide® Diskus® (fluticasone propionate/salmeterol xinafoate), and Symbicort® Turbohaler® (budesonide/formoterol fumarate). Methods: The delivered dose uniformity was tested using a dose unit sampling apparatus (DUSA) at inhalation volumes either 2.0 or 4.0 L and flow rates 30, 40, 60, or 90 L/min. The aerodynamic assessment was carried out using a Next Generation Impactor by discharging each inhaler at 30, 40, 60, or 90 L/min for a time sufficient to obtain an air volume of 4 L. Results: Foster® NEXThaler® and Seretide® Diskus® showed a consistent dose delivery for both the drugs included in the formulation, independently of the applied flow rate. Contrary, Symbicort® Turbohaler® showed a high decrease of the emitted dose for both budesonide and formoterol fumarate when the device was operated at airflow rate lower that 60 L/min. The aerosolizing performance of NEXThaler® and Diskus® was unaffected by the flow rate applied. Turbohaler® proved to be the inhaler most sensitive to changes in flow rate in terms of fine particle fraction (FPF) for both components. Among the combinations tested, Foster NEXThaler® was the only one capable to deliver around 50% of extra-fine particles relative to delivered dose. Conclusions: NEXThaler® and Diskus® were substantially unaffected by flow rate through the inhaler in terms of both delivered dose and

  12. Acute Toxicity and Gastroprotection Studies with a Newly Synthesized Steroid

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    A. Ketuly, Kamal; A. Hadi, A. Hamid; Golbabapour, Shahram; Hajrezaie, Maryam; Hassandarvish, Pouya; Ali, Hapipah Mohd; Majid, Nazia Abdul; Abdulla, Mahmood A.

    2013-01-01

    Background Synthetic steroids, such as 9α-bromobeclomethasonedipropionate, have shown gastroprotective activity. For example, the potent glucocorticoid steroid, beclomethasone dipropionate, has been used for treatment of bowel ulcerations. The purpose of the present study was to evaluate the effect of a synthetic steroid, (20S)-22-acetoxymethyl-6β-methoxy-3α,5-dihydro-3′H-cyclopropa[3α,5]-5α-pregnane (AMDCP), on ethanol-induced gastric mucosa injuries in rats. Methodology/Principal Finding Rats were divided into 8 groups. The negative control and ethanol control groups were administered Tween 20 (10%v/v) orally. The reference control group, 20 mg/kg omeprazole (10% Tween 20, 5 mL/kg), was administrated orally. The experimental groups received 1, 5, 10, 15 or 20 mg/kg of the AMDCP compound (10% Tween 20, 5 mL/kg). After 60 min, Tween 20 and absolute ethanol was given orally (5 mL/kg) to the negative control group and to the rest of the groups, and the rats were sacrificed an hour later. The acidity of gastric content, gastric wall mucus and areas of mucosal lesions were assessed. In addition, histology and immunohistochemistry of the gastric wall were assessed. Prostaglandin E2 (PGE2) and malondialdehyde (MDA) content were also measured. The ethanol control group exhibited severe mucosal lesion compared with the experimental groups with fewer mucosal lesions along with a reduction of edema and leukocyte infiltration. Immunohistochemical staining of Hsp70 and Bax proteins showed over-expression and under-expression, respectively, in the experimental groups. The experimental groups also exhibited high levels of PGE2 as well as a reduced amount of MDA. AMDCP decreased the acidity and lipid peroxidation and increased the levels of antioxidant enzymes. Conclusion/Significance The current investigation evaluated the gastroprotective effects of AMDCP on ethanol-induced gastric mucosal lesions in rats. This study also suggests that AMDCP might be useful as a

  13. Psychometric validation of the experience with allergic rhinitis nasal spray questionnaire

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    Crawford B

    2011-06-01

    Full Text Available Bruce Crawford1, Richard H Stanford2, Audrey Y Wong3, Anand A Dalal2, Martha S Bayliss11Mapi Values, Boston, MA, USA; 2GlaxoSmithKline, Research Triangle Park, NC, USA; 3BioMedical Insights, San Francisco, CA, USABackground: Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q was developed to measure subject experiences with and preferences for nasal sprays.Objective: To describe the psychometric validation of the EARNS-Q modules.Methods: An observational study was conducted with subjects aged 18–65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22.Results: The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test–retest validity. Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79 and within internal consistency reliability estimates, indicating measurement of distinct constructs.Conclusion: The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference

  14. 超高效液相色谱-串联质谱法同时测定化妆品中21种糖皮质激素%UPLC-MS/MS determination of 21 glucocorticoids in cosmetics

    Institute of Scientific and Technical Information of China (English)

    王伟萍; 张明玥; 蔺娟; 帕孜来提·亚库甫

    2013-01-01

    目的:建立快速、准确、灵敏检测化妆品中添加的21种糖皮质激素:曲安西龙、波尼松龙、氢化可的松、波尼松、可的松、倍他米松、地塞米松、氟米松、倍氟米松、波尼松龙醋酸酯、氢化可的松醋酸酯、氟米龙、地夫可特、氟氢可的松醋酸酯、甲基泼尼松龙醋酸酯、布地奈德、泼尼卡酯、安西奈德、哈西奈德、倍氟米松双丙酸酯、地塞米松醋酸酯的分析方法.方法:样品用饱和氯化钠溶液分散,用乙腈从分散液中提取激素类药物,用亚铁氰化钾和醋酸锌从提取液中沉淀大分子基质,经Oasis HLB固相萃取小柱富集净化;采用SHIMADZU Shim-pack XR-ODS色谱柱(3.0 mm×75 mm,1.8 μm),水(含0.1%乙酸)(A)-乙腈(含0.1%乙酸)(B)梯度洗脱,流速0.2 mL·min-1;离子源为ESI源,正离子扫描模式,多级反应监测测定.结果:该法各组分的平均回收率为85.7%~ 100.0%,RSD为2.6% ~ 8.9%,方法检出限为0.005 ~0.053 μg·g-1.结论:该法能满足检测化妆品中21种糖皮质激素的需要.%Objective:To establish a quick,accurate,sensitive method for analysis of 21 glucocorticoids (triamcinolone,prednisolone,hydrocortisone,prednisone,cortisone,betamethasone,dexamethasone,flumethasone,beclomethasone,prednisolone,21-acetate,fluoromethalone,hydrecortisone 21-acetateby,deflazacort,fludrocortisone 21-acetate,methylprednisolone 21-cetate,budesonide,dexamethasone-21 acetate,prednicarbate,halcinonide,amcinonide,beclometasone dipropionate) in cosmetics by UPLC-MS/MS.Methods:Sample was dispersed with saturated sodium chloride solution,extracted by acetonitrile scattered;then macromolecules from matrix were precipitated with ferrocyanatum kalium and zinc acetate,and finally extracted,enriched and purified by Oasis HLB macromolecular matrix solid-phase extraction and columella.The chromatographic was performed using a SHIMADZU Shim-pack XR-ODS analysis column (3.0 mm × 75 mm,1.8 μm) with gradient

  15. Avaliação da inflamação com base na liberação de radicais oxidantes por granulócitos na asma crônica não-controlada Assessment of inflammation based on the release of oxygen radicals by granulocytes in chronic uncontrolled asthma

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    Cristina F. Sartorelli

    2009-04-01

    Full Text Available OBJETIVO: Avaliar a liberação espontânea de ânion superóxido por granulócitos de sangue periférico de pacientes com asma crônica não-controlada antes e após corticoterapia e de indivíduos sadios. MÉTODOS: Foram estudados 32 pacientes entre 6 e 18 anos (média 12,04 anos e 29 indivíduos sadios como grupo de comparação. Os pacientes foram agrupados de acordo com o volume expiratório forçado no primeiro segundo: grupo I, volume expiratório forçado no primeiro segundo entre 60 e 80%, 19 pacientes; e grupo II, volume expiratório forçado no primeiro segundo = 60%, 13 pacientes. A liberação espontânea de superóxido por granulócitos, medida por espectrofotometria utilizando superóxido dismutase, foi avaliada nos pacientes antes e após o tratamento com prednisona por via oral e beclometasona, budesonida ou fluticasona administradas por via inalatória. Na análise estatística foram utilizados os testes de análise de variância, Tukey e de Wilcoxon. RESULTADOS: Comparando-se a liberação de ânion superóxido por granulócitos dos pacientes asmáticos e indivíduos sadios observamos que a liberação foi maior nos asmáticos não-controlados do grupo II (p OBJECTIVE: To evaluate spontaneous release of superoxide anion by peripheral blood granulocytes of atopic patients with uncontrolled asthma undergoing glucocorticoid therapy and of healthy subjects. METHODS: We studied 32 patients, aged 6 to 18 (mean 12.04, and 29 healthy subjects as a comparative group. Patients were grouped according to the forced expiratory vital capacity in the first second. Group I, forced expiratory vital capacity in the first second of between 60 and 80%, had 19 patients, and group II, forced expiratory vital capacity in the first second = 60%, had 13 patients. Spontaneous superoxide release by granulocytes was measured by a spectrophotometer method based on superoxide dismutase, before and after oral prednisone and beclomethasone, budesonide or

  16. Pico do fluxo expiratório no acompanhamento de crianças asmáticas Peak expiratory flow monitoring in asthmatic children

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    Ana Cristina C. F. Fonseca

    2006-12-01

    Full Text Available OBJETIVO: Correlacionar as medidas de volume expiratório forçado no primeiro segundo (VEF1, pico do fluxo expiratório (PFE e parâmetros clínicos em crianças com asma moderada a grave. MÉTODOS: Trata-se de um estudo de coorte não concorrente, realizado em ambulatório de pneumologia pediátrica, em Belo Horizonte, MG, de março a outubro de 2002. Participaram do estudo crianças entre 5 e 16 anos, com asma persistente, em uso de beclometasona na dosagem mínima de 500 mcg/dia, com sintomas controlados há pelo menos 3 meses. Foram selecionados 75 pacientes (96,1% de forma aleatória simples, os quais foram acompanhados durante 3 meses, sendo avaliados o escore clínico e as provas de função pulmonar (PFE e VEF1. Os resultados foram analisados através da regressão linear de Pearson. RESULTADOS: Entre os valores absolutos e percentuais do PFE e o escore clínico, a correlação foi negativa e muito próxima a zero, o que significa uma correlação fraca, sem significância estatística. O mesmo se observa entre VEF1 e escore clínico. A correlação entre VEF1 e PFE apresentou valor positivo e com significância estatística (p = 0,000. CONCLUSÕES: Como o melhor parâmetro para avaliar obstrução de vias aéreas é o VEF1, o encontro de correlação positiva entre este e os valores absolutos do PFE reforça a importância do seu uso e permite recomendar a mensuração do PFE no manejo das crianças asmáticas, sobretudo nos casos graves.OBJECTIVE:To correlate forced expiratory volume in 1 second (VEF1 and peak expiratory flow (PEF with clinical parameters in children with moderate and severe asthma. METHODS: This was a non-concurrent cohort study, carried out at a pediatric pneumology clinic, in Belo Horizonte, MG, Brazil, between March and October 2002. The study enrolled children aged 5 to 16 years, with persistent asthma, being treated with a minimum of 500 mcg/day beclomethasone, and with symptoms under control for at least 3

  17. Inhaled steroid/tobacco smoke particle interactions: a new light on steroid resistance

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    Nicolini Gabriele

    2009-06-01

    Full Text Available Abstract Background Inhaled steroid resistance is an obstacle to asthma control in asthmatic smokers. The reasons of this phenomenon are not yet entirely understood. Interaction of drug particles with environmental tobacco smoke (ETS could change the aerodynamic profile of the drug through the particle coagulation phenomenon. Aim of the present study was to examine whether steroid particles interact with smoke when delivered in the presence of ETS. Methods Beclomethasone-hydrofluoralkane (BDP-HFA pMDI particle profile was studied after a single actuation delivered in ambient air or in the presence of ETS in an experimental chamber using a light scattering Optical Particle Counter capable of measuring the concentrations of particle sized 0.3–1.0, 1.1–2.0, 2.1–3.0, 3.1–4.0, 4.1–5.0, and > 5.1 μm in diameter with a sampling time of one second. The number of drug particles delivered after a single actuation was measured as the difference between total particle number after drug delivery and background particle number. Two groups of experiments were carried out at different ambient background particle concentrations. Two-tail Student's t-test was used for statistical analysis. Results When delivered in ambient air, over 90% of BDP-HFA particles were found in the 0.3–1.0 μm size class, while particles sized 1.1–2.0 μm and 2.1–3.0 represented less than 6.6% and 2.8% of total particles, respectively. However, when delivered in the presence of ETS, drug particle profile was modified, with an impressive decrease of 0.3–1.0 μm particles, the most represented particles resulting those sized 1.1–2.0 μm (over 66.6% of total particles, and 2.1–3.0 μm particles accounting up to 31% of total particles. Conclusion Our data suggest that particle interaction between inhaled BDP-HFA pMDI and ETS takes place in the first few seconds after drug delivery, with a decrease in smaller particles and a concurrent increase of larger particles. The

  18. HIPERINFECCIÓN POR STRONGYLOIDES EN ANCIANO CON EPOC Strongyloides hyperinfection in elderly patient with COPD

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    Análida Elizabeth Pinilla-Roa

    2011-01-01

    Full Text Available Se presenta un caso de un hombre de 81 años natural de zona rural, agricultor, recolector de café 50 años atrás y jardinero por 22 años en Bogotá. Consultó por dolor abdominal de 10 días de evolución, localizado hacia mesogastrio y epigastrio. Además, disnea, tos productiva. Antecedentes: enfermedad pulmonar obstructiva crónica, cor pulmonale, fumador de 25 paquetes /año, había recibido prednisona oral y beclometasona inhalada en diversas ocasiones incluso en la última hospitalización. En el examen físico presentó signos de desnutrición, taquicardia, taquipnea; estertores en base del hemitórax derecho; abdomen: blando, depresible con dolor a la palpación profunda en epigastrio e hipocondrio derecho. Ingresó con síndrome de respuesta inflamatoria sistémica por taquicardia, taquipnea, leucocitosis 37.600 y eosinofilia 52-60%, Ig E: 180 UI/ ml. Se evidenciaron larvas rabditiformes de Strongyloides stercoralis en esputo y materia fecal. La radiografía de tórax mostró derrame pleural derecho, la ecografía hepática fue normal, la endoscopia de vías digestivas altas evidenció gastritis y duodenitis. Se inició tratamiento con ivermectina 200 mg/ Kg/dosis, con seguimiento clínico y de laboratorio con evolución clínica satisfactoria.The case is presented of an 81-years old man from a rural area who had been a farmer, a coffee harvester 50 years beforehand and a gardener in Bogotá for 22 years. He consulted because of abdominal pain having 10 days’ evolution, localized towards the mesogastrium and epigastrium. He was also suffering from dyspnoea and productive cough. Background: chronic obstructive pulmonary disease, smoking 25 packets/year, he had received oral prednisone and inhaled beclomethasone on occasions, including during his last hospitalization. Physical examination revealed signs of undernourishment, tachycardia, tachypnoea; stertors at the base of the right hemithorax; abdomen: soft, depressible with pain on