Effectiveness of ICS/LABA and LAMA/LABA in COPD due to Biomass

Abstract

Chronic obstructive pulmonary disease 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 (U/V) 62.5/25 μg on the rate of exacerbations, the time to first exacerbation, on dyspnea, health-related quality of life (HRQL) and forced expiratory volume during the first second (FEV1) and inspiratory capacity (IC) during six months in patients with COPD-B and COPD-C, at a third level referral center in Mexico City.A pilot, single-center, 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 received UMEC/VI.There were no differences in exacerbation rates between patients receiving FF/VI or UMEC/VI in either the COPD-B [0.07 (CI 95%, 0.03–0.13), 0.06 (CI 95%, 0.03–0.12] or COPD-C group [0.06 (CI 95%, 0.04–0.11); 0.08 (CI 95%, 0.05–0.13)], nor in the time of first exacerbation, nor FEV1and IC. All groups showed improvement in dyspnea and HRQL, independently of medication used.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 dyspnea and HRQL.