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

Abstract

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), FEV₁ (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 FEV₁ (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.

Keywords:

• indacaterol
• tiotropium
• biomass exposure
• inspiratory capacity
• spirometry
• six-minute walking test

Acknowledgements

This work was supported by a non-restricted grant allocated for the care of women with respiratory diseases associated with biomass, by the legislature of the Chamber of Deputies and by a restricted grant of Novartis.

Disclosure

The authors report no conflicts of interest in this work.