Background: Few treatment trials have been tested on COPD patients associated with biomass smoke exposure (COPD-B). Patients with COPD-B improve hyperinflation 24 h after inhaling long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA), and after six months of treatment, improve symptoms, quality of life, and exacerbations. However, the usefulness of LAMA or LABA for an extended period for improving quality of life and symptoms has not yet been demonstrated in the COPD-B phenotype. The primary aim of this trial was to compare tiotropium (TIO) with indacaterol (IND) in improving the quality of life measured by the Saint George's Respiratory Questionnaire (SGRQ) in COPD-B after six months of treatment.
Methods: A randomized, open-label, parallel-group clinical trial designed at a third-level health institute in Mexico City. Seventy-three COPD-B women were randomly assigned to either 150 mcg of indacaterol or 18 mcg of tiotropium once daily for 24 weeks.
Results: 197 patients underwent the screening visit, of which 73 were randomized. There was no significant change in the three domains nor the total score of the SGRQ in either treatment group. For secondary outcomes, the TIO group showed a substantial change in the IC of 160 mL (p = 0.016) after six month-treatment. For both treatment groups, a significant reduction in BDI/TDI score of 3 points was shown (p < 0.001).
Conclusions: Neither TIO nor IND improved quality of life, nor dyspnea evaluated by the mMRC scale, but TIO did improve inspiratory capacity, and TIO and IND improved dyspnea evaluated by BDI/TDI.
Clinical trial registration: NCT05506865.
Keywords: Biomass pollution; COPD; Health-related quality of life; Indacaterol; Tiotropium.
Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.