... if they get worse.Beclomethasone helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Your doctor will prescribe ...
Wahn, U; Lipinski, Ch
In addition to the usual mangement of asthma the introduction of Beclomethasone-dipropionate aerosol can be considered as a progress in the long-term treatment of asthma, because in most cases oral and parenteral application of corticosteroids is no longer necessary. According to the results of many authors the wellknown side effects of steriod therapy have so far not been observed. We report our experiences with Beclomethasone in the treatment of 19 chronically asthmatic children.
de Aguiar, M M; da Silva, H J; Rizzo, J Â; Leite, D F B; Silva Lima, M E P L; Sarinho, E S C
The aim of this study was to systematically review the safety and efficacy of inhaled beclomethasone for asthma treatment in pregnant women. We performed a systematic review in Medline, LILACS and SciELO electronic databases in December 2012. A total of 3433 articles were found by using the keywords asthma, pregnancy and beclomethasone. Among these, 1666 were from Medline, via PubMed, and 1767 were from LILACS and SciELO. Nine of these articles were selected. Only one paper suggested an increased foetal risk for congenital malformations, and one other for offspring endocrine and metabolic disturbances. Data are mostly reassuring, supporting the use of glucocorticoid inhalants during pregnancy, and we found no evidence of inferiority in relation to efficacy and safety of beclomethasone compared to other drugs used in pregnant asthmatic women. Copyright © 2013 SEICAP. Published by Elsevier Espana. All rights reserved.
Bisgaard, H; Damkjaer Nielsen, M; Andersen, B
The effect of inhaled beclomethasone dipropionate and budesonide on the adrenal function was studied in 30 children (aged 7 to 15 years) with mild bronchial asthma. The trial was designed as a prospective double-blind parallel study of the effect of stepwise increase of either beclomethasone dipr...
Gopala Krishna Murthy Talasila
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.
Shmelev, E I; Kunicina, Yu L
This study aimed to compare the clinical efficacy of two anti-inflammatory medications (fenspiride and inhaled beclomethasone [beclomethasone dipropionate]) in patients with stable chronic obstructive pulmonary disease (COPD) over 6 months. DESIGN, METHODS AND PATIENTS: This was a randomised comparison of 58 patients with COPD, divided into five treatment groups: fenspiride (stages 1 and 2), beclomethasone (stage 2), and two control groups (stages 1 and 2). In addition, 64 patients with exacerbations of COPD were evaluated over a 2-week treatment period during which they received either fenspiride or prednisolone. Clinical signs and symptoms of COPD were evaluated every 2 months (aggregated numerical index of signs and symptoms), as were lung function tests (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], FEV1/FVC) and a 6-minute walking test. Statistically significant reductions in all evaluated COPD signs and symptoms were achieved with fenspiride in stage 1 COPD. Fenspiride therapy significantly reduced the indices of sputum parameters (8-fold decrease), incidence of dry rales (6-fold decrease), dyspnoea (4-fold decrease) and cough (2.5-fold decrease). In comparison with beclomethasone, fenspiride was superior in stage 2 COPD. In patients with stage 2 COPD, reductions were less marked, but remained significantly superior in the fenspiride group in comparison with the beclomethasone group and the control groups. In patients with exacerbations of COPD, fenspiride had equivalent efficacy to that of systemic corticosteroids. Anti-inflammatory therapy with fenspiride in addition to bronchodilators significantly improved clinical signs and symptoms, external respiratory function tests and physical activity tests in patients with stage 1 COPD. Adjunctive fenspiride therapy was superior to inhaled beclomethasone in stage 2 COPD. Anti-inflammatory therapy in COPD may be more effective at an early stage of this disease.
Shukla, P.N.; Gairola, M.; Mohanti, B.K.; Rath, G.K.
Background and aims: Radiation induced wet desquamation of skin in carcinoma breast patients is a painful condition. In this study topical beclomethasone dipropionate spray was used as prophylaxis with the purpose of reducing risk of the wet desquamation of skin in irradiated field. Materials and methods: sixty patients of carcinoma breast were planned for postoperative loco regional radiotherapy (50 Gy in 25 fraction over five weeks) were prospectively randomized into two groups (1) steroid group-patients were advised to use beclomethasone dipropionate spray in irradiated axilla from day one of radiotherapy, (2) control group-patients were not allowed to use any topical agent in irradiated area. Radiation induced skin reaction was noted in terms of erythema, dry desquamation and wet desquamation weekly till end of prescribed 50Gy dose of the radiation therapy. Statistical method: Chi-square test was used to see the statistical significance of the difference in wet desquamation between two arms of the study. Chi-square value and P-value was calculated for the difference of wet desquamation in two study arms. Result: In steroid group 4/30 (13.33%) patients developed wet desquamation of the axillary skin at the end of the radiotherapy. For the control group, this figure was 11/30 (36.66%). The difference in wet desquamation of the axillary skin in the two groups was statistically significant (P-value=0.0369). Conclusion: Topical steroid (beclomethasone dipropionate spray) for skin during radiotherapy significantly reduces the risk of wet desquamation of the skin. (author)
García-Ruiz, A J; Quintano Jiménez, J A; García-Agua Soler, N; Ginel Mendoza, L; Hidalgo Requena, A; Del Moral, F
To perform a cost-utility analysis on asthmatic patients on beclomethasone/formoterol fixed combination in Primary Health Care. Material and methods Non-probability sampling was used to select a group of asthmatic patients with moderate/severe persistent severity (GEMA 2009), treated with beclomethasone/formoterol fixed combination, over 18 years, had given their informed consent. The study observation period was 6 months. The variables studied were: age, sex, duration of disease, health resources used, analysis of health related quality of life by EQ-5D and SF-36, and the specific Asthma Quality of Life Questionnaire. For the qualitative variables, the frequency and percentages were calculated, and for the quantitative variables, the mean, SD and 95% CI. Chi-square, Student t-test and ANOVA were used for statistical inference. Comparisons were made with a statistical significance of 0.05. Of the 64 patients that completed the study, 59.4% were female. The mean age was 49 years, and mean disease duration was 93 months. For asthma control, 53% of patients had a prescription pattern of one/12h. All health related quality of life scales were modified with respect to the baseline and the differences were statistically significant. Our patients had a better health related quality of life than Spanish asthma cohort. The incremental cost utility beclomethasone/formoterol versus usual treatment option was € 6,256/QALY. Copyright © 2015 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.
Bisgaard, H; Damkjaer Nielsen, M; Andersen, B
. The 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...
V. A. Nikitin
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.
Takeno, Sachio; Takeda, Kazumasa; Nishi, Yasuyuki; Ishino, Takashi; Hirakawa, Katsuhiro
Chronic rhinosinusitis (CRS) with eosinophil infiltration is characterized by unrestrained proliferation of eosinophils that form clusters in the mucus where they release toxic granules. The mechanisms by which eosinophilic inflammation damages the epithelium and contributes to recurrent acute exacerbations in the disease have not been fully elucidated. Local or systematic administration of glucocorticoids is considered to be potent treatment strategy to prevent relapse of nasal poyposis. In the present study, we assessed whether topical instillation of beclomethasone dipropionate dry powder onto the paranasal sinus improved the post-operative nasal symptoms and radiological sinus scores in patients with CRS after appropriate surgical intervention. Eighteen CRS patients with eosinophil infiltration who underwent endoscopic sinus surgery were recruited. The patients were treated with 800 μg beclomethasone every two weeks using an application device at least for 2 months. We found an improvement in the endoscopic appearance scores in 91.4% of patients who received beclomethasone. The result was better than that obtained from the previous study treated with conventional post-operative therapy (71.7%). Significant decreases in the averaged CT scores for the paranasal sinuses were noted from 5.62 to 1.93 after treatment. We consider that topical use of beclomethasone dry powder is effective for the post-surgical treatment of CRS with eosinophil infiltration through the control of the inflammatory process that persists in the nasal cavity. (author)
Singh, D.; Nicolini, G.; Bindi, E.
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......; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 mu g or FP/S 500/50 mu g twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre- dose...... in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations. Results: BDP/FF was equivalent...
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.
Bukstein, Donald; Parikh, Ruchir; Eid, Sherrine; Ferro, Thomas; Morello, Jean-Pierre
Perennial allergic rhinitis (PAR) exerts significant quality-of-life and economic burdens on society. Beclomethasone dipropionate (BDP) nasal aerosol is the first nonaqueous, hydrofluoroalkane-propelled intranasal corticosteroid approved for patients in the United States to treat PAR and seasonal allergic rhinitis. To evaluate real-world effectiveness of BDP nasal aerosol from the patient's perspective by using a postmarketing observational registry. Patients (N = 824) from 43 U.S. study sites completed monthly patient-reported outcome instruments, including the Rhinitis Control Assessment Test (primary outcome variable), Treatment Satisfaction Questionnaire for Medication, Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, Pittsburgh Sleep Quality Index, and Mini Rhinoconjunctivitis Quality of Life Questionnaire for 6 months. The primary outcome assessment (Rhinitis Control Assessment Test score) (N = 527) indicated significant symptomatic improvement over baseline beginning at month 1 (p 78.8% of respondents who achieved clinically meaningful improvement over 6 months. Secondary outcome measures Mini Rhinoconjunctivitis Quality of Life Questionnaire (p Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Allergy-Specific, with the exception of work time missed and class time missed, were significantly (p life, work, and school-related activities, and is associated with high patient satisfaction, reduced productivity loss and activity impairment, and improvement in sleep quality.
Halpin David MG
Full Text Available Abstract Background Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. Currently beclomethasone dipropionate, budesonide and fluticasone propionate are the most commonly prescribed inhaled corticosteroids for the treatment of asthma but there has been no systematic review comparing the effectiveness and safety ciclesonide to these agents. We therefore aimed to systematically review published randomised controlled trials of the effectiveness and safety of ciclesonide compared to alternative inhaled corticosteroids in people with asthma. Methods We performed literature searches on MEDLINE, EMBASE, PUBMED, the COCHRANE LIBRARY and various Internet evidence sources for randomised controlled trials or systematic reviews comparing ciclesonide to beclomethasone or budesonide or fluticasone in adult humans with persistent asthma. Data was extracted by one reviewer. Results Five studies met the inclusion criteria. Methodological quality was variable. There were no trials comparing ciclesonide to beclomethasone. There was no significant difference between ciclesonide and budesonide or fluticasone on the following outcomes: lung function, symptoms, quality of life, airway responsiveness to a provoking agent or inflammatory markers. However, the trials were very small in size, increasing the possibility of a type II error. One trial demonstrated that the combined deposition of ciclesonide (and its active metabolite in the oropharynx was 47% of that of budesonide while another trial demonstrated that the combined deposition of ciclesonide (and its active metabolite in the oropharynx was 53% of that of fluticasone. One trial demonstrated less suppression of cortisol in overnight urine collection after ciclesonide compared to fluticasone (geometric mean fold difference = 1.5, P Conclusion There is very little evidence comparing CIC to other ICS, restricted to very small, phase II studies of low
Ivey, James W; Bhambri, Pallavi; Church, Tanya K; Lewis, David A; McDermott, Mark T; Elbayomy, Shereen; Finlay, Warren H; Vehring, Reinhard
The effects of propellant type, cosolvent content, and air humidity on the morphology and solid phase of the particles produced from solution pressurized metered dose inhalers containing the corticosteroid beclomethasone dipropionate were investigated. The active ingredient was dissolved in the HFA propellants 134a and 227ea with varying levels of the cosolvent ethanol and filled into pressurized metered dose inhalers. Inhalers were actuated into an evaporation chamber under controlled temperature and humidity conditions and sampled using a single nozzle, single stage inertial impactor. Particle morphology was assessed qualitatively using field emission scanning electron microscopy and focused ion beam-helium ion microscopy. Drug solid phase was assessed using Raman microscopy. The relative humidity of the air during inhaler actuation was found to have a strong effect on the particle morphology, with solid spheroidal particles produced in dry air and highly porous particles produced at higher humidity levels. Air humidification was found to have no effect on the solid phase of the drug particles, which was predominantly amorphous for all tested formulations. A critical level of air relative humidity was required to generate porous particles for each tested formulation. This critical relative humidity was found to depend on the amount of ethanol used in the inhaler, but not on the type of propellant utilized. The results indicate that under the right circumstances water vapor saturation followed by nucleated water condensation or ice deposition occurs during particle formation from evaporating propellant-cosolvent-BDP droplets. This finding reveals the importance of condensed water or ice as a templating agent for porosity when particle formation occurs at saturated conditions, with possible implications on the pharmacokinetics of solution pMDIs and potential applications in particle engineering for drug delivery. Copyright © 2017 Elsevier B.V. All rights reserved.
Bozzini, Giorgio; Provenzano, Marco; Buffi, Nicolò; Seveso, Mauro; Lughezzani, Giovanni; Guazzoni, Giorgio; Mandressi, Alberto; Taverna, Gianluigi
Nonbacterial prostatitis, together with chronic pelvic pain syndrome, accounts for 90-95 % of prostatitis cases. Anti-inflammatory medications are commonly used to reduce storage/inflammatory symptoms that can deteriorate quality of life. The purpose of this study was to observe the efficacy and safety of beclomethasone dipropionate rectal suppositories (Topster®) in inflammations of the lower urinary tract in men. Patients underwent diagnostic and therapeutic protocols according to current evidence-based practice. Efficacy assessments: voiding parameters, perineal pain, International Prostate Symptom Score (IPSS), digital rectal examination (DRE). Adverse events and patient compliance were recorded throughout the study. One hundred eighty patients were enrolled, mean age 52 ± 14.97. Most frequent diagnosis: nonbacterial prostatitis (85 %). All patients completed visits 1 and 2. All patients were treated with beclomethasone dipropionate (BDP) suppositories, 136/180 also with Serenoa repens (SR) extract. Antibiotics were rarely required. 162/180 patients presented clinically significant improvements and terminated treatment. Mean change vs. baseline in voiding frequency: -3.55 ± 2.70 n/day in patients taking only BDP and -3.68 ± 2.81 n/day in those taking both BDP and SR (Psuppositories.
Full Text Available Dave Singh,1 Massimo Corradi,2 Monica Spinola,3 Alberto Papi,4 Omar S Usmani,5 Mario Scuri,3 Stefano Petruzzelli,3 Jørgen Vestbo1 1Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK; 2Department of Medicine and Surgery, University of Parma, Parma, Italy; 3Chiesi Farmaceutici SpA, Parma, Italy; 4Department of Medical Sciences, Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy; 5National Heart and Lung Institute, Imperial College London, London, UK Abstract: The goals of COPD therapy are to prevent and control symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance. The triple combination therapy of inhaled corticosteroids (ICSs, long-acting beta2 agonists (LABAs, and long-acting muscarinic antagonists (LAMAs has become an option for maintenance treatment of COPD and as a “step-up” therapy from single or double combination treatments. There is evidence that triple combination ICS/LABA/LAMA with different inhalers improves lung function, symptoms, and health status and reduces exacerbations. A new triple fixed-dose combination of extrafine beclomethasone dipropionate (100 µg/puff/formoterol fumarate (6 µg/puff/glycopyrronium bromide (12.5 µg/puff has been developed as a hydrofluoroalkane pressurized metered dose inhaler. Two large pivotal studies showed that this extrafine fixed ICS/LABA/LAMA triple combination is superior to fixed ICS/LABA combined therapy and also superior to the LAMA tiotropium in terms of lung function and exacerbation prevention in COPD patients at risk of exacerbation. This review considers the new information provided by these clinical trials of extrafine triple therapy and the implications for the clinical management of COPD patients. Keywords: COPD, inhaled triple therapy, beclomethasone dipropionate, formoterol fumarate and glycopyrronium bromide
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.
Komal R Dhudashia
Full Text Available Background: The combination of Clotrimazole and Beclomethasone dipropionate is used as anti-fungal and anti-inflammatory for external use in the form of cream and lotion. Aim: A simple, specific, economic, precise, and accurate reversed-phase high performance liquid chromatographic method development for the simultaneous estimation of clotrimazole (CT and beclomethasone dipropionate (BD in lotion and cream formulations. Materials and Methods: The chromatographic separation was achieved on a Kromasil C18 (150 mm × 4.6 mm, 5 μm analytical column. A mixture of acetonitrile-water (70:30, v/v was used as the mobile phase, at a flow rate of 1 ml/min and detector wavelength at 254 nm. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation, and system suitability test as per ICH guideline. Results: The retention time of CT and BD was found to be 5.4 and 4 min, respectively. The linear dynamic ranges were from 2-16 μg/ml and 80-640 μg/ml for BD and CT, respectively. Limit of detection and quantification for BD were 0.039 and 0.12 μg/ml, for CT 1.24 and 3.77 μg/ml, respectively. Conclusions: The developed method was validated and found to be simple, specific, accurate and precise and can be used for routine quality control analysis of titled drugs in combination in lotion and cream formulation.
... class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause ... your thumb. Point the applicator away from your face. If you are using the spray for the ...
Full Text Available Background & objectives: Various inhaled corticosteroids (ICSs are available to control the symptoms of asthma. Although beclomethasone dipropionate (BDP and budesonide (BUD are one of the oldest ICSs, their wide availability and low cost make them attractive options in developing countries. Due to lack of consensus on which of the two drugs is better for controlling mild persistent asthma, we undertook this study to compare the efficacy of these two drugs by measuring the change in percentage predicted forced expiratory volume in one second (FEV 1 from baseline in children with mild persistent asthma. Methods: A double-blind, randomized, parallel group study was conducted in children 7-15 yr of age with newly diagnosed asthma. Of the 85 cases of mild persistent asthma, 42 received BUD while 43 received BDP at a dose of 400 µg/day using pressurized metered-dose inhaler with valved spacer for two months. The outcomes measured were change in FEV 1 , symptom scores and side effects. Results: There was a significant (P < 0.05 improvement in FEV 1 in BUD group (98.43 ± 4.63% than in BDP group (95.65 ± 5.66% at the end of two months of treatment. The mean symptom scores in BUD group (0.28 ± 1.22 and BDP group (0.43 ± 1.52 were comparable after two months. No side effects were seen in either group. Interpretation & conclusions: FEV 1 was significantly greater in BUD group than BDP group. Improvement in symptoms and incidence of side effects were similar. Our findings indicate that both BDP and BUD can be used effectively in the management of children with mild persistent asthma. [CTRI No: CTRI/2013/03/003495].
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Singh, Dave; Kampschulte, Jorg; Wedzicha, Jadwiga A
-primary outcome, and the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) means of collecting patient-reported outcome data are also being used to enhance the detection of exacerbation events. EXACT data are being collected using a novel application of a digital platform technology. FORWARD is therefore...
Chawes, Bl; Piccinno, A; Kreiner-Møller, Eskil
/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...
Svendsen, U G; Frølund, L; Madsen, F
on logarithm-natural (Ln) (PC20), i.e., the mean effects of the two periods, was also significant (p less than 0.01). SCG, however, was most effective when it was used as the first drug, indicated by a significant increase in FVC in the first period (p less than 0.05). Neither in the first nor in the second...... period did SCG treatment influence the Ln (PC20) value positively, and the SCG treatment administered in the second period could not maintain the improvement in the pulmonary function (i.e., FEV1, FVC, and PEF) obtained initially with the BDP treatment. When the effect of BDP on FEV1, FVC, PEF, and Ln...
Comparison of the efficacy and safety of budesonide turbuhaler administered once daily with twice the dose of beclomethasone dipropionate using pressurised metered dose inhaler in patients with mild to moderate asthma.
Bashir, I.; Masood, N.
Objective: The objective of this study was to asses the occurrence and severity of sore throat following endotracheal anesthesia and its reduction by beclomethasone inhalation. Study Design: A randomized controlled trial. Place and Duration of Study: This study was carried out at the main operation theatre, Combined Military Hospital Rawalpindi from October 2002 to April 2003. Patients and Methods: Two hundred patients undergoing general anaesthesia for elective surgery were included. Patients were randomly assigned to two groups of 100 patients each. The patients in group A were given one puff inhalation of beclomethasone before intubation while group B was control group. The patients were evaluated for occurrence and severity of postoperative sore throat by direct questions 6, 12, 24 and 48 hours after surgery. Results: In the beclomethasone group, 10 patients had sore throat as compared to 55 in control group (p<0.01). All 10 patients who experienced symptoms in beclomethasone group had mild sore throat while among the patients in the control group 22 had mild, 13 had moderate and 20 had severe sore throat. After 48 hours, no patient had the symptoms in the study group while 9 of the control group still suffered from sore throat. No drug related side effects were observed. Conclusion: Postoperative sore throat after general anaesthesia is common (occurrence rate of 55%). Beclomethasone inhaler is highly effective in the prevention of postoperative sore throat. It reduces both the occurrence and severity of sore throat. (author)
... JO, Medical Department, AstraZeneca, P. O. Box 3560, Ikeja, Lagos. Vol 24, No 3 (2005) - Articles Comparison of the efficacy and safety of budesonide turbuhaler administered once daily with twice the dose of beclomethasone dipropionate using pressurised metered dose inhaler in patients with mild to moderate asthma
Comparison of the efficacy and safety of budesonide turbuhaler administered once daily with twice the dose of beclomethasone dipropionate using pressurised metered dose inhaler in patients with mild to moderate asthma · EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL ...
Wolthers, O D; Hansen, M; Juul, A
. The 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...... suppression of lower leg growth rate (F = 12.41; p = 0.002, and F = 23.30; p = 0.0001, respectively) and of urine free cortisol/creatinine x 10(6) (F = 10.52; p = 0.003, and F = 13.74; p = 0.001). Beclomethasone, 800 micrograms, caused suppression of PICP compared with fluticasone propionate, 200 micrograms...... (F = 8.31; p = 0.008), and beclomethasone, 400 micrograms (F = 7.53; p = 0.01). Both low (F = 6.82; p = 0.02) and high (F = 23.35; p = 0.0001) doses of beclomethasone were associated with reduced concentrations of ICTP, the high dose being the most suppressive (F = 4.42; p = 0.05). Beclomethasone 400...
Hey, G.; Ledin, A.; la Cour Jansen, J.
treatment dose is comparable to ClO2. Nevertheless, ozonation significantly enhanced the removal of most APIs including carbamazepine, metoprolol, flutamide, bupropion and beclomethasone. In addition, ozonation allows removal of ibuprofen at higher oxidant dose. APIs that possess the reactive electron...
We report the use of low rugosity lactose, product of controlled crystallization of this carrier, in the formulation of terbutaline sulphate and beclomethasone dipropionate dry powder inhalers. The deposition patterns obtained with inhalation mixtures consisting of the modified lactose and each of the micronised drugs ...
Ige, Pradum P; Pardeshi, Sagar R; Sonawane, Raju O
The aim of this work was to evaluate the in vitro performance of nebulized nanosuspension formulation when nebulized using ultrasonic nebulizer. The present investigation deals with successful formulation of Beclomethasone dipropionate loaded HPMCP nanospheres prepared by solvent evaporation technique using PEG 400 as a stabilizer. Beclomethasone dipropionate is a water insoluble drug molecule was encapsulated in HPMCP nanospheres to have pH dependent solubility at basic pH for targeted drug delivery in lung and studied for in vitro cytotoxicity and immediate release capability. The synthesized nanospheres were characterized through drug excipient compatibility, surface topography; mean particle size , zeta potential, PDI, entrapment efficiency and drug loading, in vitro diffusion, aerodynamic, in vitro cytotoxicity and stability studies. The mean particle size and PDI of the optimized batch (F1) had 197.6±0.40 nm and 0.324 ±0.35, respectively. The % entrapment efficiency and % drug loading was found to be 86.56±1.32 and 8.30±0.27, respectively. The optimized batch F1 showed % cumulative drug release 94.77±0.24 at 1 h. The formulation showed cell viability up to 91.28%. It can be concluded that, Beclomethasone dipropionate loaded HPMCP nanospheres was found to be safe, stable with significant increase in solubility and bypass the liver. © Georg Thieme Verlag KG Stuttgart · New York.
Zhai, Hailong; Wang, Yufang
To verify the effect of a new nasal spray made from natural medicines on allergic rhinitis in animals. Methods: The main natural medicines contained in Acusine nasal spray plus essential traditional Chinese medicine contained in drugs for allergic rhinitis in Chinese market were used. By preparation process of extraction of traditional Chinese medicine such as steam distillation, ethanol extraction, a new nasal spray made from natural medicines was prepared. In the meantime, 24 BALB/c mice and New Zealand white rabbits were used. Then, mice were randomly divided into four group; control group, beclomethasone dipropionate group, Acusine group and new spray group, 6 mice in each group. Moreover, the effect of the new nasal spray made on passive cutaneous anaphylaxis was conducted by detecting absorptions of Evan’s blue (620nm) in the four groups. Allergic rhinitis models in 40 New Zealand white rabbits were established. Consequently, 40 allergic rhinitis models in rabbits were randomly divided into control group, Acusine group and new spray group, 10 rabbits in each group. The four groups were sprayed nasally with saline, Acusine spray and new spray respectively, three times/d, for 30 days. The nasal resistances in the four groups were measured with a rhinoresistometer. Moreover, their nasal mucosa was taken for HE staining. Consequently, their pathological manifestations were observed. The results: Absorption of Evan’s blue (620nm) of new spray group will be found significantly lower than Acusine group (P0.05). On the other hand, absorption of Evan’s blue (620nm) of beclomethasone dipropionate group will be significantly lower than Acusine group (Psimilar with beclomethasone dipropionate, than Acusine Nasal Spray but also will not leave side effect on nasal mucosa, compared with beclomethasone dipropionate. Thus, the new spray made from natural medicines can be further studied as a better prescription drug, rather than an OTC like Acusine Nasal Spray, to
Melo, Janaina; Moreno, Adriana; Ferriani, Virginia; Araujo, Ana Carla; Vianna, Elcio; Borges, Marcos; Roxo, Pérsio; Gonçalves, Marcos; Mello, Luane; Parreira, Rosa; Silva, Jorgete; Stefanelli, Patricia; Panazolo, Larissa; Cetlin, Andrea; Queiroz, Luana; Araujo, Rosângela; Dias, Marina; Aragon, Davi; Domingos, Nélio; Arruda, L Karla
Asthma is under-diagnosed in many parts of the world. We aimed to assess the outcome of a capacitating program on asthma for non-specialist physicians and other healthcare professionals working in the public system in Ribeirão Preto, Brazil. A group of 16 asthma specialists developed a one-year capacitating program in 11 healthcare clinics in the Northern District of the city, which included lectures on asthma, training on inhalation device use and spirometry, and development of an asthma management protocol. Researchers visited one health unit 2-4 times monthly, working with doctors on patients' care, discussing cases, and delivering lectures. Asthma education was also directed to the general population, focusing on recognition of signs and symptoms and long-term treatment, including production of educational videos available on YouTube. Outcome measures were the records of doctors' prescriptions of individual asthma medications pre- and post-intervention. Prior to the program, 3205 units of inhaled albuterol and 2876 units of inhaled beclomethasone were delivered by the Northern District pharmacy. After the one-year program, there was increase to 4850 units (51.3%) for inhaled albuterol and 3526 units (22.6%) for inhaled beclomethasone. The albuterol increase followed the recommendation given to the non-specialist doctors by the asthma experts, that every patient with asthma should have inhaled albuterol as a rescue medication, by protocol. No increase was observed in other districts where no capacitating program was conducted. A systematic capacitating program was successful in changing asthma prescription profiles among non-specialist doctors, with increased delivery of inhaled albuterol and beclomethasone.
Full Text Available Corticosteroids are the most potent inhaled anti-inflammatory drugs for asthma treatment. This paper reviews the clinical evidence supporting the early use of inhaled steroids in asthma as a first line treatment. Inhaled steroids can probably alter the course of asthma, especially in mild asthmatics. Once they have been shown to improve control of asthma and even if the need for beta2-agonists is virtually nil, their use should be continued at low doses (ie, equivalent to 400 to 500 μg of budesonide or beclomethasone for at least one year before attempting to reduce the dosage.
Full Text Available Forty-six asthmatic children with repeated respiratory infections presented symptoms of allergic rhinitis. All patients were treated locally for allergic rhinitis either with disodium cromoglycate or beclomethasone dipropionate. After six months of treatment, 95% of the children showed improvement of allergic rhinitis and 84% improvement of bronchial asthma, as well as fewer infections. We concluded that allergic rhinitis plays an important role in facilitating infections of the upper respiratory tract, and a possible association of rhinitis, viral infections and bronchial asthma is discussed.
Wolthers, O D; Hansen, M; Juul, A
suppression of lower leg growth rate (F = 12.41; p = 0.002, and F = 23.30; p = 0.0001, respectively) and of urine free cortisol/creatinine x 10(6) (F = 10.52; p = 0.003, and F = 13.74; p = 0.001). Beclomethasone, 800 micrograms, caused suppression of PICP compared with fluticasone propionate, 200 micrograms....... The 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...
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.
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
Cássio C. Ibiapina
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
Full Text Available Abstract Current guidelines recommend the use of inhaled corticosteroids (ICS for suppression of airway inflammation in patients with asthma. Although it is well known that ICS cause dose-related adrenocortical suppression, it is less known that they can lead to iatrogenic Cushing’s syndrome (CS. Fluticasone propionate (FP is an ICS more potent than beclomethasone and budesonide. FP is metabolized as mediated by cytochrome P450 3A4 in the liver and the gut. Systemic bioactivity of FP can increase with the use of drugs that affect the cytochrome P450. Herein, we report the rapid development of iatrogenic CS in a patient receiving paroxetine and mirtazepine for 12 weeks in addition to inhaled FP.
Andersen, Jens Hinge; Hansen, Lene Gram; Pedersen, Mikael
was to design a procedure that minimised this difference while using a single SPE procedure and a fast HPLC method that enabled sufficient separation of the epimers beta- and dexamethason. To include conjugated corticosteroids in the analysis, the sample was hydrolysed with Helix Pomatia β...... strong anion exchange SPE column. The final method was validated according to EU regulations for determination of residues of veterinarian drugs in products of animal origin. Initial results showed a large difference in ion suppression between samples of porcine and bovine urine. The aim of optimisation......-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...
Full Text Available Context : Chronic diseases like asthma have significant effects on patients′ health-related quality of life (HRQoL. HRQoL measures additional indices as compared to objective measurements like spirometry. Aims: To assess and compare disease-specific quality of life in asthma patients using St. George′s Respiratory Questionnaire (SGRQ receiving fluticasone, beclomethasone, and budesonide (BUD. Settings and Design: A prospective, open label, randomized, parallel group study conducted at a tertiary care teaching hospital in South India. Materials and Methods: A 6-month follow-up of 277 patients with mild, moderate, and severe persistent asthma was randomized to receive fluticasone propionate (FP, BUD, or beclomethasone dipropionate (BDP in equipotent doses according to their global initiative on asthma (GINA severity. Statistical analysis used: Data analyzed using SPSS version: 13.0. General linear-repeated measures using the post-hoc bonferroni method assessed significance between treatment groups. Results: Significant decrease (P < 0.05 in each SGRQ domains and total scores as well as improvement in FEV 1 (P < 0.05 was observed in all study subjects. A significant early response (P < 0.05 was noted after 15 days treatment in patients receiving FP with respect to SGRQ (activity, impact and total scores and dyspnea indices, but not FEV 1 . This improvement with FP was due to its greater effect in patients with moderate and severe persistent asthma. No difference was noted subsequently in all outcome measures studied until 6 months. Conclusions: There was evidence for an early QoL improvement to FP as compared to BUD or BDP in moderate and severe persistent asthma. Subsequently, the three ICS showed similar improvements in lung functions and dyspnea indices throughout the study.
López Tiro, J Jesús; Contreras, E Angélica Contreras; del Pozo, M Elena Ramírez; Gómez Vera, J; Larenas Linnemann, D
Even though there are multiple options for the treatment of asthma, there still exists a fair group of patients with difficult-to-control asthma. We describe for the first time the real-world effects of three-year omalizumab treatment on patients with difficult-to-control asthma, seen in a social security hospital in a Latin American country. Difficult-to-control asthmatic patients from the out-patient clinic of a regional hospital were recruited to receive a three-year omalizumab course. Efficacy parameters were asthma control test (ACT) score; FEV1; daily beclomethasone maintenance dose; and unplanned visits for asthma exacerbations (emergency room (ER), hospitalisations, intensive care). 52 patients were recruited, 47 completed the three-year treatment (42 female, 15-67 years, mean age 43.5). Comparing efficacy parameters of the year before omalizumab with the 3rd year of omalizumab: mean ACT improved from 12.4 to 20.5, mean FEV1 from 66.3% (standard deviation (SD) 19.1%) to 88.4% (SD 16.2%) of predicted, while mean beclomethasone dose reduced from 1750 to 766 mcg/day and there was a significant reduction in patients experiencing ER visits (from 95% to 19%, pomalizumab, two because of an adverse event (anaphylaxis, severe headache, both resolved without sequelae). Omalizumab improved most clinical parameters of Mexican patients with difficult-to-control asthma. Especially the rates of ER visits and hospitalisation were significantly reduced, thus reducing costs. Omalizumab was generally well tolerated. Copyright © 2013 SEICAP. Published by Elsevier Espana. All rights reserved.
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.
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
Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva
Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents. Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p = 0.41); visits to an emergency room: 1 versus 6 ( p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p = 0.05). Few Adverse Events were reported. This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating
Gómez-Cerquera, Juan Manuel; Hernando-López, Elena; Blanco-Ramos, José Ramón
Highly effective antiretroviral treatment has improved the life expectancy of human immunodeficiency virus (HIV) infected patients, but has led to an increase in the comorbidities related to aging, such as the chronic obstructive pulmonary disease (COPD). All this implies the need for a greater number of drugs and an increasing risk of drugs interactions with antiretroviral treatment, particularly protease inhibitors. We report a case of iatrogenic adrenal insufficiency interaction secondary to ritonavir and inhaled fluticasone in an HIV-infected patient with COPD. A review was made of the cases reported in adults in the medical literature (Medline) up to December 2012. A total of 34 cases were reported. The mean age was 4 years. The mean dose of ritonavir was 187 mg/day, while the fluticasone dose was 866 μg/day. The average time of the interaction between ritonavir and fluticasone was 8 months. In 85% of cases fluticasone was discontinued at the time of diagnosis of adrenal insufficiency/Cushing syndrome. Almost all (90%) patients had a complete resolution of the symptoms after changing the treatment. HIV-infected patients on antiretroviral therapy with protease inhibitor boosted with ritonavir which requires the use of inhaled corticosteroids, beclomethasone would be the best treatment option. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
Ricardo A Tan
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
Full Text Available BACKGROUND The eye is especially susceptible to the symptoms of allergic rhinitis, itching (pruritus, tearing (epiphora and redness (erythema because it lacks a mechanical barrier that could prevent the deposition of allergens, such as pollen on the conjunctival surface. These ocular symptoms have been described as examples of the type 1 immediate hypersensitivity reaction. A number of recently published clinical studies apparently support the positive effect of intranasal steroidal sprays on ocular allergy symptoms. The aim of the study is to evaluate the role of intranasal steroids in relieving ocular symptoms in allergic rhinitis. MATERIALS AND METHODS 60 subjects who had seasonal allergic rhinitis with ocular symptoms came to Outpatient Department of Chalmeda Anand Rao Hospital in the year 2015-2016. Randomly, each intranasal steroid is given to 12 patients to a total of 60 patients for 4 weeks 2 puffs in each nostril twice daily and the clinical response is observed. RESULTS A subjective improvement in ocular symptoms was observed in 11 of the 12 patients treated with fluticasone furoate, 8 of 12 patients with fluticasone propionate, 7 of the 12 patients with mometasone furoate, 6 of the 12 patients with beclomethasone and 6 of the 12 patients with budesonide. CONCLUSION Intranasal corticosteroids, which are used for seasonal allergic rhinitis with ocular symptoms are effective in controlling of ocular symptoms. Among these, intranasal corticosteroids, which are used for allergic rhinitis, fluticasone furoate is more effective in relieving ocular symptoms in our study.
Dotsenko, E K; Goncharova, V A; Kuzubova, N A; Kamenova, M Iu; Egorova, N V
To study biochemical composition of expired air condensate (EAC) in patients with chronic obstructive pulmonary disease (COPD) in relation to a phase and severity of the disease and its treatment. EAC was investigated in 18 COPD patients and 9 healthy subjects. Basic broncholytic therapy with ipratropium bromide was combined with beclomethasone and fenspiride in 11 and 7 patients, respectively. The condensate was lyophilised, the residue was solved and analysed on the biochemical analyzer Casis (Beringer Manheim, Rosch). EAC was examined for albumin, C-reactive protein, glucose, cholesterol, triglycerides, urea, uric acid, alkaline phosphatase (AP), lactate dehydrogenase, gamma-glutamyl transferase, total calcium, magnesium. Compared to healthy subjects, COPD patients' EAC contains significantly higher levels of albumin, C-reactive protein, calcium, bilirubin and more active AP. Quantitative composition of EAC depends on COPD phase and severity. A negative correlation exists between FEV+AEA-1 and albumin concentration, FEV+AEA-1 and CRP concentration. The anti-inflammatory therapy decreases EAC content of both protein and lipid metabolism products, enzyme activity reflecting attenuation of oxidant and inflammatory processes, stabilization of cell membranes in the respiratory zone. EAC composition reflects metabolic processes in the lungs and can be used for assessment of airway affection, activity of the inflammatory process and COPD treatment efficacy.
Mazzarino, Monica; Rossi, Francesca; Giacomelli, Laura; Botre, Francesco
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
Full Text Available Long-term treatment with inhaled corticosteroids has been shown to result in improvement of symptoms and lung function in subjects with asthma. Arachidonic acid (AA metabolites are thought to play a role in the pathophysiology of asthma. It was assessed whether differences could be found in bronchoalveolar lavage (BAL AA metabolite levels between subjects with asthma who were treated for 2.5 years with inhaled bronchodilators alone or in combination with inhaled corticosteroids. Prostaglandin (PGD2, PGF2α, 6-keto-PGF1α, thromboxane B2, leukotriene (LTC4 and LTB4 levels and cell numbers were assessed in BAL fluid from 22 non-smoking asthmatic subjects. They were participating in a randomized, double-blind multicentre drug trial over a period of 2.5 years. Results of the group treated with inhaled corticosteroids (CS+: beclomethasone 200 μg four times daily were compared with the other group (CS− which was treated with either ipratropium bromide (40 μg four times daily or placebo. BAL LTC4 levels of asthmatic subjects were significantly lower after 2.5 years inhaled corticosteroid therapy (CS+, 9(1–17 pg/ml vs. CS−, 16(6-53 pg/ml; p = 0.01. The same trend was observed for the PGD2 levels. The results suggest that inhaled corticosteroids may exert their beneficial effect on lung function via a mechanism in which inhibition of LTC4 synthesis in the airways is involved.
Full Text Available Inhaled corticosteroids are potent and effective treatment agents for controlling symptoms of childhood asthma. However, there are no predictive factors that help to determine which patients with asthma are likely to be tapered off inhaled corticosteroids successfully. We examined whether any factor or combination of factors could help the clinician safely discontinue inhaled steroid therapy. Thirty-six asthmatic children whose symptoms were stable on low-dose beclomethasone dipropionate (BDP were divided by parental choice into two groups: maintenance BDP (n = 11 and no BDP (n = 25. Methacholine inhalation tests were performed at the beginning of the study and after 1 month. Twelve children (48% who had BDP discontinued developed exacerbations after 2–3 months, whereas there were no problems in the maintenance group. The no BDP group was retrospectively divided into two subgroups: exacerbation (+ and (−. The threshold to methacholine in the exacerbation (+ subgroup decreased significantly in advance of clinical symptoms. The two subgroups were analyzed statistically by two-group discriminant function analysis. The change in threshold to methacholine, the dose and potency of drugs, duration of asthma and gender (female correlated with exacerbation. These results suggest that discontinuation of inhaled steroids should be done carefully, even in stable asthmatic children. The methacholine inhalation test, gender, drugs and history may be used as references for discontinuing inhaled steroids.
Chen, Yang; Young, Paul M; Fletcher, David F; Chan, Hak Kim; Long, Edward; Lewis, David; Church, Tanya; Traini, Daniela
To investigate the influence of different actuator nozzle designs on aerosol electrostatic charges and aerosol performances for pressurised metered dose inhalers (pMDIs). Four actuator nozzle designs (flat, curved flat, cone and curved cone) were manufactured using insulating thermoplastics (PET and PTFE) and conducting metal (aluminium) materials. Aerosol electrostatic profiles of solution pMDI formulations containing propellant HFA 134a with different ethanol concentration and/or model drug beclomethasone dipropionate (BDP) were studied using a modified electrical low-pressure impactor (ELPI) for all actuator designs and materials. The mass of the deposited drug was analysed using high performance liquid chromatography (HPLC). Both curved nozzle designs for insulating PET and PTFE actuators significantly influenced aerosol electrostatics and aerosol performance compared with conducting aluminium actuator, where reversed charge polarity and higher throat deposition were observed with pMDI formulation containing BDP. Results are likely due to the changes in plume geometry caused by the curved edge nozzle designs and the bipolar charging nature of insulating materials. This study demonstrated that actuator nozzle designs could significantly influence the electrostatic charges profiles and aerosol drug deposition pattern of pMDI aerosols, especially when using insulating thermoplastic materials where bipolar charging is more dominant.
Thalberg, Kyrre; Åslund, Simon; Skogevall, Marcus; Andersson, Patrik
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. Copyright © 2016 Elsevier B.V. All rights reserved.
Derendorf, H; Meltzer, E O
Intranasal corticosteroids (INSs) are effective treatments for allergic rhinitis, rhinosinusitis, and nasal polyposis. In recent years, increased understanding of corticosteroid and glucocorticoid receptor pharmacology has enabled the development of molecules designed specifically to achieve potent, localized activity with minimal risk of systemic exposure. Pharmacologic potency studies using affinity and other assessments have produced similar rank orders of potency, with the most potent being mometasone furoate, fluticasone propionate, and its modification, fluticasone furoate. The furoate and propionate ester side chains render these agents highly lipophilic, which may facilitate their absorption through nasal mucosa and uptake across phospholipid cell membranes. These compounds demonstrate negligible systemic absorption. Systemic absorption rates are higher among the older corticosteroids (flunisolide, beclomethasone dipropionate, triamcinolone acetonide, and budesonide), which have bioavailabilities in the range of 34-49%. Studies, including 1-year studies with mometasone furoate, fluticasone propionate, and budesonide that evaluated potential systemic effects of INSs in children have generally found no adverse effects on hypothalamic-pituitary-adrenal axis function or growth. Clinical data suggest no significant differences in efficacy between the INSs. Theoretically, newer agents with lower systemic availability may be preferable, and may come closer to the pharmacokinetic/pharmacologic criteria for the ideal therapeutic choice.
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: firstname.lastname@example.org
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.
Myint, Melissa; Bucki, Robert; Janmey, Paul A; Diamond, Scott L
Certain membrane-active cationic steroids are known to also possess both anti-inflammatory and antimicrobial properties. This combined functionality is particularly relevant for potential therapies of infections associated with elevated tissue damage, for example, cystic fibrosis airway disease, a condition characterized by chronic bacterial infections and ongoing inflammation. In this study, six novel cationic glucocorticoids were synthesized using beclomethasone, budesonide, and flumethasone. Products were either monosubstituted or disubstituted, containing one or two steroidal groups, respectively. In vitro evaluation of biological activities demonstrated dual anti-inflammatory and antimicrobial properties with limited cytotoxicity for all synthesized compounds. Budesonide-derived compounds showed the highest degree of both glucocorticoid and antimicrobial properties within their respective mono- and disubstituted categories. Structure-activity analyses revealed that activity was generally related to the potency of the parent glucocorticoid. Taken together, these data indicate that these types of dual acting cationic lipids can be synthesized with the appropriate starting steroid to tailor activities as desired. Copyright © 2015 Elsevier Ltd. All rights reserved.
Margiotta-Casaluci, Luigi; Owen, Stewart F.; Huerta, Belinda; Rodríguez-Mozaz, Sara; Kugathas, Subramanian; Barceló, Damià; Rand-Weaver, Mariann; Sumpter, John P.
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.
Full Text Available David Price,1,2 Vicky Thomas,2 Julie von Ziegenweidt,2 Shuna Gould,2 Catherine Hutton,2 Christine King2 1Academic Centre of Primary Care, University of Aberdeen, Aberdeen, UK; 2Research in Real Life, Oakington, Cambridge, UK Purpose: To investigate the clinical and cost effectiveness of switching real-life asthma patients from other types of inhalers to the Easyhaler® (EH for the administration of inhaled corticosteroids (ICS. Patients and methods: Historical, matched-cohort study of 1,958 asthma patients (children and adults treated in UK primary-care practices, using data obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink. Other inhalers (OH included pressurized metered-dose inhalers, breath-actuated inhalers, and dry-powder inhalers, delivering beclomethasone, budesonide, fluticasone, or ciclesonide. Patients remaining on OH unchanged (same drug, dosage, and device; n=979 were matched 1:1 with those switched to the EH (beclomethasone or budesonide at the same or lower ICS dosage (n=979, based on age, sex, year of index patient review/switch, most recent ICS drug, dosage, and device, and the number of severe exacerbations and average daily short-acting β2 agonist (SABA dosage in the preceding year. Clinical outcomes and health care costs were compared between groups for 12 months before and after the switch. Co-primary clinical outcomes were: 1 risk domain asthma control (RDAC – no asthma-related hospitalization, acute oral steroid use, or lower respiratory tract infection (LRTI; 2 exacerbation rate (American Thoracic Society [ATS] definition – where exacerbation is asthma-related hospitalization or acute oral steroid use; 3 exacerbation rate (clinical definition – where exacerbation is ATS exacerbation or LRTI; and 4 overall asthma control (OAC – RDAC plus average salbutamol-equivalent SABA dosage ≤200 μg/day. Non-inferiority (at least equivalence of EH was tested against OH for the
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
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.
Kelso, T M; Abou-Shala, N; Heilker, G M; Arheart, K L; Portner, T S; Self, T H
To determine if a comprehensive long-term management program, emphasizing inhaled corticosteroids and patient education, would improve outcomes in adult African-American asthmatics a nonrandomized control trial with a 2-year intervention was performed in a university-based clinic. Inclusion criteria consisted of (> or = 5) emergency department (ED) visits or hospitalizations (> or = 2) during the previous 2 years. Intervention patients were volunteers; a comparable control group was identified via chart review at hospitals within the same area and time period as the intervention patients. Individualized doses of beclomethasone with a spacer, inhaled albuterol "as needed," and crisis prednisone were the primary therapies. Environmental control, peak flow monitoring, and a partnership with the patient were emphasized. Detailed patient education was an integral part of management. Control patients received usual care from local physicians. ED visits and hospitalizations for 2 years before and 2 years during the intervention period were compared. Quality of life (QOL) measurements were made at baseline and every 6 months in the intervention group. Study group (n = 21) had a significant reduction in ED visits (2.3 +/- 0.2 pre-intervention versus 0.6 +/- 0.2 post-intervention; P = 0.0001). Control group (n = 18) did not have a significant change in ED visits during the 2-year post-intervention period (2.6 +/- 0.2 pre-intervention versus 2.0 +/- 0.2 post-intervention; P = 0.11). Both groups had significant reductions in hospitalizations, but the study group had a greater reduction. Sixty-two percent of study patients had complete elimination of ED visits and hospitalizations, whereas no control patients had total elimination of the need for institutional acute care. QOL in the study patients revealed significant improvements for most parameters. A comprehensive long-term management program emphasizing inhaled corticosteroids combined with other state-of-the-art management
Full Text Available Study objectives were to compare the numbers of lymphocytes and lymphocyte subpopulations in induced sputum from asthmatic patients and from healthy subjects, and to determine the effect of inhaled anti-asthmatic steroid therapy on these cell numbers. Hypertonic saline inhalation was used to non-invasively induce sputum samples in 34 patients with bronchial asthma and 21 healthy subjects. The sputum samples were reduced with dithioerythritol and absolute numbers of lymphocytes and lymphocyte subpopulations were assessed by direct immunofluorescence and flow cytometry. To assess the effect of beclomethasone dipropionate (BDP on induced sputum, numbers of lymphocytes and lymphocyte subpopulations in sputum also were evaluated after 4 weeks of BDP inhalation treatment in seven asthmatic patients. An adequate sample was obtained in 85.3% of patients with asthma and in 79.2% of the healthy subjects. Induced sputum from patients with asthma had increased numbers of lymphocytes (P = 0.009; CD4+ cells (P = 0.044; CD4+ cells-bearing interleukin-2 receptor (CD25; P = 0.016; and CD4+ cells bearing human histocompatibility leukocyte antigen (HLA-DR (P = 0.033. CD8+ cells were not increased in asthmatic patients. In patients treated with inhaled steroids, numbers of lymphocytes, CD4+ cells, CD25-bearing CD4+ cells and HLA-DR-bearing CD4+ cells in sputum decreased from pretreatment numbers (P = 0.016, 0.002, 0.003 and 0.002, respectively. Analysis of lymphocytes in induced sputum by flow cytometry is useful in assessing bronchial inflammation, and activated CD4+ lymphocytes may play a key role in the pathogenesis of airway inflammation in bronchial asthma.
Engelkes, Marjolein; van Blijderveen, Jan C; Overbeek, Jetty A; Kuiper, Josephine; Herings, Ron C M; Sturkenboom, Miriam C J M; de Jongste, Johan C; Verhamme, Katia M C; Janssens, Hettie M
The expiration of patents of brand inhalation medications and the ongoing pressure on healthcare budgets resulted in a growing market for generics. To study the use of brand and generic inhalation medication and the frequency of switching between brand and generic and between devices. In addition, we investigated whether switching affected adherence. From dispensing data from the Dutch PHARMO Database Network a cohort aged ≥ 5 years, using ≥ 1 year of inhalation medication between 2003 and 2012 was selected. Switching was defined as changing from brand to generic or vice versa. In addition, we studied change in aerosol delivery device type (e.g., DPI, pMDI, and nebulizers). Adherence was calculated using the medication possession ratio (MPR). The total cohort comprised 70,053 patients with 1,604,488 dispensations. Per calendar year, 5% switched between brand and generic inhalation medication and 5% switched between devices. Median MPRs over the first 12 months ranged between 33 and 55%. Median MPR over the total period was lower after switch from brand to generic and vice versa for formoterol (44.5 vs. 42.1 and 63.5 vs. 53.8) and beclomethasone (93.8 vs. 59.8 and 81.3 vs. 55.9). Per year, switching between brand and generic inhalation medication was limited to 5% of the patients, switching between device types was observed in 5% as well. Adherence to both generic and brand inhalation medication was low. Effect of switching on adherence was contradictory; depending on time period, medication and type, and direction of switching. Further research on reasons for switching and potential impact on clinical outcomes is warranted.
Full Text Available Background and the purpose of the study Existing evidence confirms that no pharmacologic agent ameliorates the decline in the lung function or changes the prognosis of chronic obstructive pulmonary disease (COPD. We tried a critical combination therapy for management of COPD. Methods Current or past smoker (passive or active COPD patients with moderate to severe COPD who did not respond to primitive therapy (i.e., oral prednisolone (50 mg in the morning for 5 days; with Beclomethasone Fort (3 puff q12h, totally 1500 micrograms/day, Salmeterol (2 puffs q12h, 50 micrograms/puff and ipratropium bromide (4 puffs q8h for two months, enrolled to study. Furthermore they were received N-Acetylcysteine (1200 mg/daily, Azithromycin (tablet 250 mg/every other day and Theophylline (100 mg BD.Results The study group consisted of 44 men and 4 women, with a mean age and standard deviation of 63.6+/-12.7 years (range 22-86 years. Thirteen of 48 patients (27.0% was responder based on 15% increasing in FEV 1 (27.7+/-7.9 after 6.7+/-6.1 months (57.9+/-12.9 year old. There were statistically significant differences in age and smoking between responders and nonresponders (P value was 0.05 and 0.04 respectively. There was no difference in emphysema and air trapping between two groups (p=0.13. Conclusion Interestingly considerable proportion of patients with COPD can be reversible using combination drug therapy and patients will greatly benefit from different and synergic action of the drugs. The treatment was more effective in younger patients who smoke less.
Postma, Dirkje S.; Dekhuijzen, Richard; van der Molen, Thys; Martin, Richard J.; van Aalderen, Wim; Roche, Nicolas; Guilbert, Theresa W.; Israel, Elliot; van Eickels, Daniela; Khalid, Javaria Mona; Herings, Ron M.C.; Overbeek, Jetty A.; Miglio, Cristiana; Thomas, Victoria; Hutton, Catherine; Hillyer, Elizabeth V.
Purpose Extrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone). Methods This historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change. Results Each cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide. Conclusions In this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS. PMID:28102056
Pérez, María Hernández-Alcalá; Cormack, Jonathan; Mallinson, David; Mutungi, Gabriel
Glucocorticoids (GCs) are steroid hormones released from the adrenal gland in response to stress. They are also some of the most potent anti-inflammatory and immunosuppressive drugs currently in clinical use. They exert most of their physiological and pharmacological actions through the classical/genomic pathway. However, they also have rapid/non-genomic actions whose physiological and pharmacological functions are still poorly understood. Therefore, the primary aim of this study was to investigate the rapid/non-genomic effects of two widely prescribed glucocorticoids, beclomethasone dipropionate (BDP) and prednisolone acetate (PDNA), on force production in isolated, intact, mouse skeletal muscle fibre bundles. The results show that the effects of both GCs on maximum isometric force (Po) were fibre-type dependent. Thus, they increased Po in the slow-twitch fibre bundles without significantly affecting that of the fast-twitch fibre bundles. The increase in Po occurred within 10 min and was insensitive to the transcriptional inhibitor actinomycin D. Also, it was maximal at ∼250 nM and was blocked by the glucocorticoid receptor (GCR) inhibitor RU486 and a monoclonal anti-GCR, suggesting that it was mediated by a membrane (m) GCR. Both muscle fibre types expressed a cytosolic GCR. However, a mGCR was present only in the slow-twitch fibres. The receptor was more abundant in oxidative than in glycolytic fibres and was confined mainly to the periphery of the fibres where it co-localised with laminin. From these findings we conclude that the rapid/non-genomic actions of GCs are mediated by a mGCR and that they are physiologically/therapeutically beneficial, especially in slow-twitch muscle fibres.
Chen, Yang; Young, Paul M; Fletcher, David F; Chan, Hak Kim; Long, Edward; Lewis, David; Church, Tanya; Traini, Daniela
To investigate the influence of different actuator materials and nozzle designs on the electrostatic charge properties of a series of solution metered dose inhaler (pMDI) aerosols. Actuators were manufactured with flat and cone nozzle designs using five different materials from the triboelectric series (Nylon, Polyethylene terephthalate, Polyethylene-High density, Polypropylene copolymer and Polytetrafluoroethylene). The electrostatic charge profiles of pMDI containing beclomethasone dipropionate (BDP) as model drug in HFA-134a propellant, with different concentrations of ethanol were studied. Electrostatic measurements were taken using a modified electrical low-pressure impactor (ELPI) and the deposited drug mass assayed chemically using HPLC. The charge profiles of HFA 134a alone have shown strong electronegativity with all actuator materials and nozzle designs, at an average of -1531.34 pC ± 377.34. The presence of co-solvent ethanol significantly reduced the negative charge magnitude. BDP reduced the suppressing effect of ethanol on the negative charging of the propellant. For all tested formulations, the flat nozzle design showed no significant differences in net charge between different actuator materials, whereas the charge profiles of cone designs followed the triboelectric series. The electrostatic charging profiles from a solution pMDI containing BDP and ethanol can be significantly influenced by the actuator material, nozzle design and formulation components. Ethanol concentration appears to have the most significant impact. Furthermore, BDP interactions with ethanol and HFA have an influence on the electrostatic charge of aerosols. By choosing different combinations of actuator materials and orifice design, the fine particle fractions of formulations can be altered.
Yeung, Stewart; Traini, Daniela; Tweedie, Alan; Lewis, David; Church, Tanya; Young, Paul M
This study was performed to investigate how increasing the active pharmaceutical ingredient (API) content within a formulation affects the dispersion of particles and the aerosol performance efficiency of a carrier based dry powder inhalable (DPI) formulation, using a custom dry powder inhaler (DPI) development rig. Five formulations with varying concentrations of API beclomethasone dipropionate (BDP) between 1% and 30% (w/w) were formulated as a multi-component carrier system containing coarse lactose and fine lactose with magnesium stearate. The morphology of the formulation and each component were investigated using scanning electron micrographs while the particle size was measured by laser diffraction. The aerosol performance, in terms of aerodynamic diameter, was assessed using the British pharmacopeia Apparatus E cascade impactor (Next generation impactor). Chemical analysis of the API was observed by high performance liquid chromatography (HPLC). Increasing the concentration of BDP in the blend resulted in increasing numbers and size of individual agglomerates and densely packed BDP multi-layers on the surface of the lactose carrier. BDP present within the multi-layer did not disperse as individual primary particles but as dense agglomerates, which led to a decrease in aerosol performance and increased percentage of BDP deposition within the Apparatus E induction port and pre-separator. As the BDP concentration in the blends increases, aerosol performance of the formulation decreases, in an inversely proportional manner. Concurrently, the percentage of API deposition in the induction port and pre-separator could also be linked to the amount of micronized particles (BDP and Micronized composite carrier) present in the formulation. The effect of such dose increase on the behaviour of aerosol dispersion was investigated to gain greater insight in the development and optimisation of higher dosed carrier-based formulations. Copyright © 2018 Elsevier B.V. All
Ketuly, Kamal A; Hadi, A Hamid A; Golbabapour, Shahram; Hajrezaie, Maryam; Hassandarvish, Pouya; Ali, Hapipah Mohd; Abdul Majid, Nazia; Abdulla, Mahmood A
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. 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. 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 gastroprotective agent.
Rodríguez-Martínez, Carlos E; Sossa-Briceño, Mónica P; Castro-Rodriguez, Jose A
The choice among the different treatments available can have a great impact on the costs of asthma, The objective of this study was to estimate the incremental cost-utility ratio of three inhaled corticosteroids (ICs): budesonide (BUD), fluticasone propionate (FP), and ciclesonide, compared to beclomethasone dipropionate (BDP) (the only IC included in the Compulsory Health Insurance Plan of Colombia), A Markov-type model was developed to estimate costs and health outcomes of a simulated cohort of patients less than 18 years of age with persistent asthma treated over a 12-month period. Effectiveness parameters were obtained from a systematic review of the literature. Cost data were obtained from a hospital´s bills and from the national manual of drug prices. The study assumed the perspective of the national healthcare in Colombia. The main outcome was the variable "quality-adjusted life years" (QALY), RESULTS: While treatment with BDP was associated with the lowest cost (£106.16 average cost per patient during 12 months), treatment with FP resulted in the greatest gain in QUALYs (0.9325 QALYs). FP was associated with a greater gain in QALYs compared to BUD and ciclesonide (0.9325 vs. 0.8999 and 0.9051 QALYs, respectively) at lower costs (£231.19 vs. £309.27 and £270.15, respectively), thus leading to dominance. The incremental cost-utility ratio of FP compared to BDP was £19,835.28 per QALY, CONCLUSIONS: BDP is the most cost-effective therapy for treating pediatric patients with persistent asthma when willingness to pay (WTP) is less than £21,129.22/QALY, otherwise, FP is the most cost-effective therapy.
[Study of personal best value of peak expiratory flow in patients with asthma--comparison of the highest value of daily PEF under good control and the highest value of daily PEF obtained after using repeated inhaled beta2-agonist during high-dose inhaled steroid treatment].
Watanabe, Naoto; Makino, Sohei; Kihara, Norio; Fukuda, Takeshi
In the guideline for asthma management, it is important to find the personal best value of peak expiratory flow (best PEF). Recently, we have substituted the highest value of PEF in daily life under good control (daily highest PEF) for the best PEF. In the present study, we considered whether the daily highest PEF could be used as the best PEF or not. Subjects were 30 asthmatics who were well controlled but whose baseline PEF values were less than 80 percent of predicted values. We compared the daily highest PEF and the highest of PEF obtained after repeated inhaled beta2-agonist (salbutamol MDI every 20 minutes three times). All subjects then received 1600 microg/day of beclomethasone dipropionate (BDP) for 4 to 8 weeks. We studied the effect of high-dose inhaled steroid treatment on each PEF value and compared the daily highest PEF and the highest PEF obtained after using repeated salbutamol MDI during high dose inhaled steroid therapy on the examination day again. The baseline PEF, daily highest PEF and the highest PEF obtained after salbutamol MDI were significantly less than the each values obtained after high-dose BDP. The best PEF value of them was the value obtained after repeated salbutamol MDI during high dose BDP. We suggest that the daily highest PEF under good control is not a substitute for best PEF because it changes according to the degree of improvement of airway inflammation. We recommend that a course of high dose inhaled steroid is effective in finding the best value of PEF for each individual with moderate asthma.
Blaiss, Michael S
Intranasal corticosteroids (INSs) are the most efficacious medication for the treatment of allergic rhinitis. In 2006, the Joint Task Force of the American College of Allergy, Asthma, and Immunology, and the American Academy of Allergy, Asthma, and Immunology, published a white paper on the potential over-the-counter switch of INS (Bielory L, Blaiss M, Fineman SM, et al. Concerns about intranasal corticosteroids for over-the-counter use: Position statement of the Joint Task Force for the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 96:514-525, 2006). The concern of the paper was the safety of the use of these agents without oversight by a health care professional. The objective of this paper was to review published literature on the safety of INS since the publication of the task force white paper. Recent studies, which evaluated topical and systemic adverse events associated with ciclesonide (CIC), fluticasone furoate (FF), mometasone furoate (MF), triamcinolone acetonide, fluticasone propionate, budesonide, and beclomethasone dipropionate were summarized. In general, no significant topical or systemic complications were observed in these studies, although none were >1 year in duration. The newer formulations of topical corticosteroids for allergic rhinitis, such as CIC, FF, and MF, which have less systemic bioavailability, may be safer for long-term use. New studies continue to add to the reassurance of the safety of INSs in the treatment of allergic rhinitis but still do not answer the question if these agents are appropriate for long-term use without oversight by a health care professional.
Rebuck, A S
Despite regular inhalation of beta-agonists, topical steroids and anticholinergic aerosols and the achievement of therapeutic blood levels of theophylline, some asthmatics have rapidly fluctuating levels of peak flow measurements throughout the day. Often little or no improvement is obtained with larger doses of corticosteroids. Before embarking on more intense drug therapy, attention should be paid to conscientious adherence to the prescribed regimen and avoidance of aspirin and tartrazine, as well as to exposure to allergens such as those associated with household pets. A number of newer therapeutic options are related to the use of air jet or ultrasonic nebulizers, that allow liquid forms of inhalation agents to be taken slowly in the home environment. In this regard, combination therapy with a beta-agonist and the anticholinergic ipratropium has been shown to have bronchodilating properties superior to either agent used alone. Secondly, sodium cromoglycate in its liquid form appears to have bronchodilator properties; taken on a regular basis, four times per day, it appears to have a steroid-sparing effect. Two alternatives are available for increasing the intensity of corticosteroid therapy, other than by prolonged, high-dose prednisone. The first is that of high-dose inhaled beclomethasone (up to 2000 micrograms/day) using the 250 micrograms/puff inhaler. The second is that of intravenous therapy with methylprednisolone, recently shown to have lung permeability superior to that of prednisolone. Office patients can be treated with occasional or even regular 'pulse' doses of methylprednisolone, an approach that is now finding acceptance in the management of the inflammatory alveolitides.
Prykhozhij, Sergey V; Marsico, Annalisa; Meijsing, Sebastiaan H
The zebrafish (Danio rerio) is an established model organism for developmental and biomedical research. It is frequently used for high-throughput functional genomics experiments, such as genome-wide gene expression measurements, to systematically analyze molecular mechanisms. However, the use of whole embryos or larvae in such experiments leads to a loss of the spatial information. To address this problem, we have developed a tool called Zebrafish Expression Ontology of Gene Sets (ZEOGS) to assess the enrichment of anatomical terms in large gene sets. ZEOGS uses gene expression pattern data from several sources: first, in situ hybridization experiments from the Zebrafish Model Organism Database (ZFIN); second, it uses the Zebrafish Anatomical Ontology, a controlled vocabulary that describes connected anatomical structures; and third, the available connections between expression patterns and anatomical terms contained in ZFIN. Upon input of a gene set, ZEOGS determines which anatomical structures are overrepresented in the input gene set. ZEOGS allows one for the first time to look at groups of genes and to describe them in terms of shared anatomical structures. To establish ZEOGS, we first tested it on random gene selections and on two public microarray datasets with known tissue-specific gene expression changes. These tests showed that ZEOGS could reliably identify the tissues affected, whereas only very few enriched terms to none were found in the random gene sets. Next we applied ZEOGS to microarray datasets of 24 and 72 h postfertilization zebrafish embryos treated with beclomethasone, a potent glucocorticoid. This analysis resulted in the identification of several anatomical terms related to glucocorticoid-responsive tissues, some of which were stage-specific. Our studies highlight the ability of ZEOGS to extract spatial information from datasets derived from whole embryos, indicating that ZEOGS could be a useful tool to automatically analyze gene expression
O. B. Demianova
Full Text Available Goal. To study the dependence between the recurrent balanoposthitis of mixed etiology and oral sex. To assess the efficacy, tolerance and cosmetic acceptability of a combination topical drug on the basis of a cream for the treatment of balanoposthitis of Candida and bacterial etiology. Materials and methods. An open-label single-arm non-randomized study involved 48 men aged 22-43 suffering from recurrent balanoposthitis of mixed etiology and their long-term sex partners. All of the subjects underwent the following tests: complete blood count, clinical urine test, blood biochemistry (AST, ALT, total bilirubin, thymol test and blood glucose, MRSA, blood tests for anti-hepatitis B and C virus antibodies, HIV-1/-2 antibody screening test, microscopy of urethral, vaginal and cervical canal materials, PCR for Chlamydia trachomatis, Trichomonas vaginalis, N. gonorrhoeae, Mycoplasma genitalium, Ureaplasma spp, bacterial swab tests based on urethral materials (in men, vaginal materials (in women and throat (in subjects of both sexes, and microscopy of tongue scrapings. 46 male patients used the Candiderm cream (Glenmark Pharmaceuticals Ltd. for 10-14 days. Physicians assessed the efficacy based on the symptom intensity and patient’s opinion. Results. In people who practiced unprotected oral sex, a high contamination of mucous coats in the oral cavity, throat and genitals with yeast fungi and opportunistic bacteria was revealed. C. Аlbicans was often found in diagnostically significant amounts in couples. The authors substantiate the possibility of a contact-type transmission of opportunistic bacteria during oral sex resulting in balanoposthitis of mixed Candida and bacterial etiology or exacerbation of their condition after sexual contacts in men practicing unprotected oral sex. Evident clinical efficacy and safety of the combination as well as good tolerance and convenience of application of the combination topical drug comprising beclomethasone
Abstract The zebrafish (Danio rerio) is an established model organism for developmental and biomedical research. It is frequently used for high-throughput functional genomics experiments, such as genome-wide gene expression measurements, to systematically analyze molecular mechanisms. However, the use of whole embryos or larvae in such experiments leads to a loss of the spatial information. To address this problem, we have developed a tool called Zebrafish Expression Ontology of Gene Sets (ZEOGS) to assess the enrichment of anatomical terms in large gene sets. ZEOGS uses gene expression pattern data from several sources: first, in situ hybridization experiments from the Zebrafish Model Organism Database (ZFIN); second, it uses the Zebrafish Anatomical Ontology, a controlled vocabulary that describes connected anatomical structures; and third, the available connections between expression patterns and anatomical terms contained in ZFIN. Upon input of a gene set, ZEOGS determines which anatomical structures are overrepresented in the input gene set. ZEOGS allows one for the first time to look at groups of genes and to describe them in terms of shared anatomical structures. To establish ZEOGS, we first tested it on random gene selections and on two public microarray datasets with known tissue-specific gene expression changes. These tests showed that ZEOGS could reliably identify the tissues affected, whereas only very few enriched terms to none were found in the random gene sets. Next we applied ZEOGS to microarray datasets of 24 and 72 h postfertilization zebrafish embryos treated with beclomethasone, a potent glucocorticoid. This analysis resulted in the identification of several anatomical terms related to glucocorticoid-responsive tissues, some of which were stage-specific. Our studies highlight the ability of ZEOGS to extract spatial information from datasets derived from whole embryos, indicating that ZEOGS could be a useful tool to automatically analyze gene
Carrigy, Nicholas B; O'Reilly, Connor; Schmitt, James; Noga, Michelle; Finlay, Warren H
During the aerosol delivery device design and optimization process, in vitro lung dose (LD) measurements are often performed using soft face models, which may provide a more clinically relevant representation of face mask dead volume (MDV) and face mask seal (FMS) than hard face models. However, a comparison of MDV, FMS, and LD for hard and soft face models is lacking. Metal, silicone, and polyurethane represented hard, soft, and very soft facial materials, respectively. MDV was measured using a water displacement technique. FMS was measured using a valved holding chamber (VHC) flow rate technique. The LD of beclomethasone dipropionate (BDP) delivered via a 100-μg Qvar® pressurized metered dose inhaler with AeroChamber Plus® Flow-Vu® VHC and Small Mask, defined as that which passes through the nasal airways of the idealized infant geometry, was measured using a bias tidal flow system with a filter. MDV, FMS, and LD were measured at 1.5 lb and 3.5 lb of applied force. A mathematical model was used to predict LD based on experimental measurements of MDV and FMS. Experimental BDP LD measurements for ABS, silicone, and polyurethane at 1.5 lb were 0.9 (0.6) μg, 2.4 (1.9) μg, and 19.3 (0.9) μg, respectively. At 3.5 lb, the respective LD was 10.0 (1.5) μg, 13.8 (1.4) μg, and 14.2 (0.9) μg. Parametric analysis with the mathematical model showed that differences in FMS between face models had a greater impact on LD than differences in MDV. The use of soft face models resulted in higher LD than hard face models, with a greater difference at 1.5 lb than at 3.5 lb. A lack of a FMS led to decreased dose consistency; therefore, a sealant should be used when measuring LD with a hard ABS or soft silicone face model at 1.5 lb of applied force or less.
Full Text Available Arundoss Gangadharan,1 Paul McCoy,2 Aye Phyo,1 Michael P McGuigan,3 Poonam Dharmaraj,1 Renuka Ramakrishnan,1 Paul S McNamara,2,4 Joanne Blair1 1Department of Endocrinology, 2Department of Respiratory Medicine, Alder Hey Children’s Hospital, Liverpool, 3Department of Paediatrics, Countess of Chester Hospital NHS Foundation Trust, 4Institute in the Park, University of Liverpool, Alder Hey Children’s Hospital, Liverpool, UK Objective: To describe recovery of adrenal insufficiency in asthmatic children treated with inhaled corticosteroids (ICS and cortisol replacement therapy.Design: Retrospective, observational study.Patients: A total of 113 patients, 74 male; age 10.4 (3.3–16.5 years; beclomethasone-equivalent ICS dose, 800 µg, (100–1,000, tested by low dose short Synacthen (tetracosactide test (LDSST, were studied. Test results were classified by basal and peak cortisol concentration: “normal” (basal >100 nmol/L, peak >500 nmol/L, “suboptimal” (basal >100 nmol/L, peak 350–499 nmol/L, “abnormal” (basal <100 nmol/L and/or peak <350 nmol/L. Patients with suboptimal results received hydrocortisone during periods of stress only, and those with abnormal responses received daily hydrocortisone, increased during periods of stress. A total of 73 patients (68% had ≥2 LDSSTs over 2.2 years (0.2–7.7.Measurements: Change in cortisol response to repeat LDSST (movement between diagnostic groups, difference in basal and peak cortisol >15% [2× the inter-assay coefficient of variation], change in BMI and height standard deviation score (SDS.Results: Baseline test results were abnormal in 17 patients (15% and all of them had repeat tests. In 13 patients (76%, test results improved (normal in six, suboptimal in seven and four (24% remained abnormal. Baseline tests results were suboptimal in 54 patients (48%, of whom 50 (93% were retested. Repeat tests were normal in 36 patients (72%, remained suboptimal in 11 (22%, and were abnormal
Elisete E. Arend
international scientific journals. There is considerable controversy regarding the side effects of inhaled corticosteroids. In 21 studies evaluating the effect that inhaled corticosteroids have on growth, a statistically significant reduction (growth retarded by 1-1.5 cm was observed within the first year of treatment with Beclomethasone or Budesonide inhalers. However, in studies of longer duration, no significant difference was found between final adult height and adult height of the parents. However, in ten studies of the use of inhaled corticosteroids and their effect on adrenal suppression, hypoglycemia and arrested development (no height or weight gains, as well as changes in morning serum levels and 24-h urinary levels of cortisol, were reported, especially when high doses of inhaled corticosteroids were used. Inhaled corticosteroids can reduce growth during the first year of use but do not affect adult height. However, further long-term studies are needed in order to determine the full impact of inhaled corticosteroids on final adult height. Height measures are a means of evaluating the safety and efficacy of the use of inhaled corticosteroids in children. Tests that evaluate the hypothalamic-pituitary-adrenal axis and adrenal insufficiency should be correlated with clinical symptoms and side effects.
Fernando D. Saraví
effects of IGs on bone metabolism markers and bone mineral density in adults and in pediatric patients. The reviewed studies do not provide uniform results. Nevertheless, in general they suggest that IGs can affect metabolism and bone mineral density, especially: 1 when high doses are administered (more than 400 µg/day in children and more than 800 µg/day in adults, 2 in pediatric patients, in whom growth in stature can also be affected, 3 in patients whose intake of calcium and vitamin D is inadequate, and 4 in postmenopausal women not undergoing hormone replacement therapy. In general, at therapeutically equivalent doses, beclomethasone has a greater deleterious effect on bone than does budesonide, which in turn has more of an effect than does fluticasone. In addition to the obvious precaution of using the lowest effective dose, other proposed preventive measures include: 1 adequate instruction on the use of aerosols, 2 the use of large volume spacer devices, 3 rinsing the mouth after administering IGs, and 4 dietary adjustments or supplements in order to ensure an adequate intake of calcium and vitamin D.
Cesar Rente Ferreira
sulfate (27%, beclomethasone (33.8% and ibuprofen (41.9%. The drugs that showed the greatest variation among the prices charged were: propranolol (97.1%, hydrochlorothiazide (96.4% and glibenclamide (95.0%, while the least variable were salbutamol (30.8% and trimethoprim-sulfamethoxazole (30.2%. Generic drugs, which were half (10 of those assessed, had the lowest prices. The indicators of access, referring to the ability of patients to acquire drugs for the treatment of major diseases at the primary health care level, showed that no establishment stocked all 20 essential drugs and that wide variations existed in their prices, undermining their availability to drug users, whose only sources are pharmacies and drugstores. These data demonstrate the importance of the popular pharmacy to improve the access to medicines, by lowering the cost and increasing the availability of the items selected for the National List of Essential Drugs (RENAME. Keywords: Drug Price. Economics, Pharmaceutical. Drugs, Generic. Pharmacoepidemiology.