Efficacy of salbutamol and budesonide metered-dose inhaler in preventing exercise-induced bronchoconstriction in patients with mild asthma

Budesonide/albuterol (salbutamol) combination (BDA) is a fixed combination of salbutamol (albuterol) and budesonide in the form of a metereddose aerosol for inhalation, the efficacy and safety of which have been demonstrated by several international phase III clinical trials in adults, adolescents, and children with asthma. This clinical trial is part of a program to study BDA in asthma patients with exercise-induced bronchospasm (EIB).

The aim of the study was to evaluate the efficacy and safety of budesonide/salbutamol compared with placebo in patients with asthma and EIB.

Methods. Adult patients with EIB (defined as a fall in forced expiratory volume in 1 second (FEV1) ≥ 20% from pre-exercise (PE) values) participating in a double-blind, crossover study were randomized to a single dose of study medication in the sequence BDA (160/180 mcg)/placebo (n = 31) or the reverse sequence (n = 33). Serial FEV1 measurements were made 5 min before and 30 min after drug administration (i.e., 5 min before the treadmill exercise challenge (ECT); baseline) and 5, 10, 15, 30, and 60 min after PE. The primary efficacy endpoint was the maximum percentage fall in FEV1 from baseline at 60 min after ECT.

Results. With BDA, the mean maximum percentage of FEV1 decline within 60 minutes after ECT was 6.95% vs 22.4% with placebo (the difference between the drugs was 17.52% (95% confidence interval was 15.25 – 19.78%; p < 0.001). The protective effect in preventing EIB (determined by the maximum decline in FEV1 after ECT < 10%) was achieved in a greater number of patients after BDA compared with placebo (75.0% and 3.1%, respectively; p < 0.001). The effect was demonstrated both in the overall study population and in the subpopulations of patients who received and did not receive inhaled corticosteroids. The single dose of BDA showed satisfactory tolerability in the study.

Conclusion. The study results confirmed the possibility of using BDA (160/180 mcg) as a new and effective pharmacological method to prevent EIB.

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