Comparison of the efficacy of beclometasone dipropionate and fluticasone propionate suspensions for nebulization in adult patients with persistent asthma

Abstract

The use of nebulization for the administration of inhaled steroids plays an important role in asthma patients who are unable to use pressurized aerosol or dry-powder inhalers effectively. Moreover, the type of nebulizer used may affect how much drug is delivered to the lungs. The objective of this multinational, multicentre, randomized, active controlled, parallel-group study was to compare the efficacy and safety of nebulized corticosteroids in adult patients with chronic asthma. Following a 1-week placebo run-in period, 205 patients, aged 18–65 years, with moderate persistent asthma were randomized to one of two treatment groups for 12 weeks: beclometasone dipropionate (BDP) suspension for nebulization 2400 μg day −1 b.i.d. ( n=103), or fluticasone propionate (FP) suspension for nebulization 2000 μg day −1 b.i.d. ( n=102), both administered by a jet nebulizer. Comparable efficacy in controlling asthma was demonstrated by the two treatments at study end, as evident when evaluating various efficacy parameters (pulmonary function tests, asthma exacerbations and symptoms, and the use of rescue salbutamol). The primary efficacy endpoint was the variation in the pulmonary expiratory flow (PEF) at treatment end over the baseline visit. For the intent-to-treat popoulation, in the BDP group mean PEF values increased statistically significantly from 5·2 ± 1·31 s −1 to 5·7 ± 1·61 s −1, while in the FP group the increase was from 5·2 ± 1·21 s −1 to 5·8 ± 1·81 s −1. Mean PEF values as per cent of predicted also increased in a statistically significant way, from 71% to 77·1% in the BDP group, and from 70·1% to 76·9% in the FP group. The two treatments were equally well tolerated. A total of 23 and 32 patients in the BDP and FP groups, respectively, reproted adverse events during the treatment period, and these were generally mild. In conclusion, the results of this study demonstrate that BDP 2400 μg day −1 and FP 2000 μg day −1, both suspensions for nebulization administered via a jet nebulizer, are equally effective, with an acceptable safety and tolerability profile, when used in adult patients with moderate persistent asthma.