The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study
Laurie Lee, Edward Kerwin, Kathryn Collison, Linda Nelsen, Wei Wu, Shuying Yang, Steven Pascoe, Laurie Lee, Edward Kerwin, Kathryn Collison, Linda Nelsen, Wei Wu, Shuying Yang, Steven Pascoe
Abstract
Introduction: The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma. We assessed FF/UMEC in patients with a primary diagnosis of asthma or chronic obstructive pulmonary disease (COPD), but physiological characteristics of both (fixed airflow obstruction and reversibility to salbutamol).
Methods: This double-blind, parallel-arm, 3-phase study randomised 338 patients (1:1:1:1:2:2) to FF 100 mcg alone or combined with UMEC (15.6, 62.5, 125, or 250 mcg) or vilanterol 25 mcg (Phase A, 4 weeks). Primary endpoint: change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) (end of Phase A). Secondary endpoints: morning peak expiratory flow (PEF), rescue medication use and Evaluating Respiratory Symptoms in COPD (E-RS™: COPD) scores. Safety was assessed.
Results: In the intent-to-treat population, the increase in trough FEV1 over FF was significant for FF/UMEC 62.5 (0.140 L [p = 0.019]) and 125 mcg (0.120 L [p = 0.039]), with similar changes for patients with a primary diagnosis of asthma or COPD. Changes from baseline in morning PEF and E-RS total score were greater for all FF/UMEC doses vs FF (p ≤ 0.05). Change from baseline in rescue medication use was statistically or clinically significant for all FF/UMEC doses vs FF. The incidence of on-treatment adverse events was 15%-32% (Phase A), with no dose-related effects.
Conclusions: FF/UMEC 62.5 mcg produced clinically meaningful improvements in FEV1, morning PEF, E-RS total score and rescue medication use. FF/UMEC may benefit patients with features of both asthma and COPD. CLINICALTRIALS.GOV: NCT02164539; GSK: 200699.
Keywords: Asthma; Chronic obstructive pulmonary disease; Inhaled corticosteroids; Long-acting muscarinic antagonist; Umeclidinium.
Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed