Bronchodilators for hyperinflation in COPD associated with biomass smoke: clinical trial

摘要

Introduction: The efficacy of long-acting bronchodilators for COPD associated with biomass (BE-COPD) has not been properly evaluated. Objective: To determine the acute effect of indacaterol (IND) 150 μg q.d and tiotropium (TIO) 18 μg q.d. on lung hyperinflation, walking distance (WD) and dyspnea during the six-minute walking test (6MWT) in moderate BE-COPD at 30, 60 and 240 mins post-drug administration. Design: Randomized, controlled, open-level, crossover noninferiority clinical trial. Forty-two women with BE-COPD were randomly assigned to a bronchodilator sequence: IND–TIO or vice versa. Results: There were statistically significant changes over time in inspiratory capacity (IC) ( p 0.0001), FEVsub1/sub ( p 0.0001) and FVC ( p 0.0001) when IND was used. When TIO was administered, an increase over all time periods was observed only for FEVsub1/sub ( p 0.0001) and FVC ( p 0.0001), whereas for IC an increase was observed only at 30 mins and 24 hrs after TIO administration. We did not find clinically significant increases in WD and dyspnea after the administration of both bronchodilators. Conclusion: Both IND and TIO showed significant and fast onset improvement in hyperinflation. Therefore, either of them may be recommended as a first line of treatment for COPD associated with BE-COPD.