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A 3-Month Comparative Dose-Reduction Study with Inhaled Beclomethasone Dipropionate and Budesonide in the Management of Moderate to Severe Adult Asthma

 

作者: Christian Brambilla,   Philippe Godard,   Jacques Lacronique,,   François Alain Allaert,   Pierre Duroux,  

 

期刊: Drug Investigation  (ADIS Available online 1994)
卷期: Volume 8, issue 1  

页码: 49-56

 

ISSN:0114-2402

 

年代: 1994

 

出版商: ADIS

 

数据来源: ADIS

 

摘要:

The efficacy of the modes of inhalation of 2 inhaled steroids (IS) were compared: beclomethasone dipropionate (BDP) delivered by pressurised metered dose inhaler (p MDI) and budesonide delivered by the inspiratory driven powder inhaler Turbuhaler®.146 asthmatic patients (mean age ± SD: 49 ± 13 years) treated for at least 6 months with constant doses of BDP (1000 to 2000μg per day) entered into an open, parallel group trial. After a 4-week run-in period, they were randomised to receive either BDP or budesonide at supposedly equivalent doses (BDP 1 puff 250μg ≡ budesonide 1 dose 200μg) for 12 weeks. Every 4 weeks the daily dose of IS was adjusted for control of disease as assessed by a 4-graded asthma score.Both treatment groups were comparable: puffs/doses (mean ± SD) of IS per day at randomisation were 5.6 ± 1.5 for the budesonide group versus 5.8 ± 1.4 for the BDP group (p = NS). 18 patients (10 in the budesonide group, 8 in the BDP group) did not complete the trial. At the end of the study, symptoms of asthma, morning and evening peak expiratory flow, puffs of &bgr;2-agonists per 24 hours, and short courses of oral steroids were comparable, but puffs/doses of IS per day (primary efficacy variable) were significantly lower in the budesonide than in the BDP group (4.5 ± 2.1vs5.4 ± 2.0; p = 0.009).The results of this trial show that budesonide administered via Turbuhaler®is more effective per μg than BDP delivered by p MDI.

 

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