DENVER – Lung function and health-related quality of life improved for COPD patients who received the long-acting muscarinic agent (LAMA) umeclidinium with fixed-dose inhaled corticosteroid/long-acting beta antagonist (LABA) therapy, based on a post hoc analysis of pooled data from four phase III trials.
Compared with inhaled corticosteroid (ICS)/LABA therapy alone, the triple therapy increased the number of rescue-free days, Dr. Thomas Siler, a pulmonologist with Midwest Chest Consultants, St. Charles, Mo., reported at an international conference of the American Thoracic Society.
The analysis involved 819 patients treated with 62.5 mcg of umeclidinium (Ellipta) – an approved maintenance treatment for COPD – plus ICS/LABA, 821 patients treated with 125 mg umeclidinium plus ICS/LABA, and 818 who received placebo and ICS/LABA. Statistically significant improvements were seen with active triple therapy vs. dual therapy plus placebo in forced expiratory volume in 1 second (FEV1) at day 85 (0.130 L) and at all other time points, as well as in 0-6 h weighted mean FEV1 at day 84 (0.152 L), Dr. Siler said.
Dr. Thomas Siler
With active triple therapy vs. dual therapy plus placebo, overall rescue use was reduced by 0.3 puffs/day and the number of rescue-free days increased by 7.1%. Also, St. George’s Respiratory Questionnaire (SGRQ) score at day 84 decreased by 1.55 vs. placebo, and the proportion of SGRQ responders was 41% vs. 31% for umeclidinium vs. placebo (odds ratio, 1.6).
Moderate/severe COPD exacerbations were experienced by 88 patients: 31 (4%) of the umeclidinium group patients and 57 (7%) of the placebo group patients (hazard ratio, 0.53).
The findings were similar in the patients who received off-label 125-mg dosing of umeclidinium, and the incidence of adverse events and serious adverse events was similar across treatment groups. Dr. Siler noted.
Data on the benefits of LAMAs in triple therapy in patients with moderate to very severe COPD are limited. This pooled analysis of data from four randomized, double-blind, parallel-group 12-week trials of once-daily add-on umeclidinium included COPD patients who entered a 4-week run-in on open-label ICS/LABA (either fluticasone furoate/vilanterol 100/25 mcg or fluticasone propionate/salmeterol 250/50 mcg), and who were then randomized to receive 62.5 or 125 mcg of umeclidinium or placebo.
GlaxoSmithKline funded the study.