A single blinded randomised trial to compare the efficacy and safety of once daily budesonide (400jig) administered by turbuhaler® with beclomethasone dipropionate (400j.ig) given twice daily through a metered-dose inhaler in patients with mild to moderate asthma

Abstract

The study compared clinical efficacy and safety of beclomethasone dipropionate (BDP) given at a dose of 400|Ig in the mornings and evenings and delivered via pressurised metered dose inhaler (pMDI) with budesonide given via a dry-powder, inspiratory flow driven device at a daily dose of 400jlg in the evening. The study was conducted as a week screening. 8-week open comparative clinical trial. At the commencement of the therapy, the baseline characteristics of the patients randomised into the two drug groups were comparable. Efficacy was assessed by changes in symptoms, number of times beta,-agonist was used and results of pulmonary function tests (PEF and FEVj) while safety was assessed by adverse event experiences. At the end of the study, 24 patients (12 in each group) were evaluated. Both drugs were effective in reducing asthma symptoms and frequency of beta,-agonist usage, as well as improving the lung function tests (FEV, and PEF). However, budesonide given via Turbuhaler provided better effects in all parameters. The drugs were well tolerated and no adverse event was noticed in any of the patients. We therefor e conclude d that budesonide Turbuhaler, R) administered once daily at a dose of400|i g is more efficaciousthan beclomethasone 400|ig twice daily administered via pressurized metered dose inhaler.