Effectiveness of ICS/LABA and LAMA/LABA in COPD due to biomass.

Background: COPD due to biomass exposure (COPD-B) is highly prevalent in low- and middle-income countries, and there are no clinical trials designed to evaluate the effectiveness of the treatments currently recommended for patients with COPD due to cigarette smoking (COPD-C). The purpose of the study was to compare the efficacy of fluticasone furoate/vilanterol (FF/V) 100/25 μg and umeclidinium/vilanterol (UMEC/VI) 62.5/25 μg on the rate of exacerbations, the time to first exacerbation, on dyspnoea, health-related quality of life (HRQL), forced expiratory volume in 1 s (FEV) and inspiratory capacity (IC) during a period of 6 months in patients with COPD-B and COPD-C, at a third level referral centre in Mexico City.

Methods: A pilot, single-centre, open-label, parallel-group study included 132 patients with a history of at least two exacerbations. They were randomised to receive one of four treatment groups: 33 COPD-B patients received FF/VI 100/25 μg, 31 COPD-B patients received UMEC/VI 62.5/25 μg, 34 COPD-C patients received FF/V and 34 COPD-C patients received UMEC/VI.

Results: There were no differences in exacerbation rates between patients receiving FF/VI or UMEC/VI in either the COPD-B (0.07 (95% CI 0.03-0.13), 0.06 (95% CI 0.03-0.12)) or COPD-C group (0.06 (95% CI 0.04-0.11), 0.08 (95% CI 0.05-0.13)), nor in the time of first exacerbation, nor FEV and IC. All groups showed improvement in dyspnoea and HRQL, independently of medication used.

Conclusions: Among patients with COPD-B and COPD-C with a history of exacerbation, FF/VI was equally effective as UMEC/VI in preventing exacerbations and improving dyspnoea and HRQL.