Abstract
BackgroundWe report the long-term effects of triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) vs glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF) on symptoms and health-related quality of life (HRQoL) over 52 weeks in the Phase III ETHOS study of patients with moderate-to-very severe COPD. MethodsETHOS was a randomized, double-blind, multi-center, parallel-group study in symptomatic patients with COPD who experienced ≥1 moderate/severe exacerbation in the previous year. Patients received twice-daily BGF 320/18/9.6 μg, BGF 160/18/9.6 μg, GFF 18/9.6 μg, or BFF 320/9.6 μg, administered via a single Aerosphere inhaler, for 52 weeks. ResultsThe modified intent-to-treat population included 8509 patients (mean age 64.7 years; 59.7% male; mean COPD Assessment Test score, 19.6). BGF significantly reduced rescue medication use vs GFF and BFF (−0.53 puffs/day [p < 0.0001] and −0.35 puffs/day [p = 0.0002], respectively, with BGF 320 over 52 weeks). BGF 320 also significantly improved St George's Respiratory Questionnaire (SGRQ) total score over 24 and 52 weeks vs dual therapies, resulting in the greatest proportion of SGRQ responders vs dual therapies over 24 weeks (52.5% vs 42.5% [GFF] and 45.2% [BFF]) and 52 weeks (47.0% vs 37.8% [GFF] and 41.0% [BFF]). Similar results were observed with BGF 160.Benefits were also observed vs dual therapies in symptomatic endpoints including Transition Dyspnea Index focal score, EXAcerbations of Chronic pulmonary disease Tool total scores and Evaluating Respiratory Symptoms in COPD total scores over 24 and 52 weeks. ConclusionsBGF triple therapy improved symptoms and HRQoL vs dual therapies over 24 and 52 weeks in patients with moderate-to-very severe COPD.
Highlights
Chronic obstructive pulmonary disease (COPD) is an increasing contributor to disability, morbidity, and mortality worldwide, ranking as the third global leading cause of death [1,2]
Significant improvements were observed for the EXAcerbations of Chronic pulmonary disease Tool (EXACT) total score for both doses of budesonide/glycopyrrolate/formoterol fumarate (BGF) vs glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF) over 24 weeks
We have shown that BGF, at two inhaled corticosteroid (ICS) dose levels, improved symptoms and health-related quality of life (HRQoL) compared with both GFF and BFF dual therapies over the 52-week study duration with, generally, no loss of effect over 52 weeks of treatment
Summary
Chronic obstructive pulmonary disease (COPD) is an increasing contributor to disability, morbidity, and mortality worldwide, ranking as the third global leading cause of death [1,2]. Patient-reported outcome measures such as rescue medication use, the St George’s Res piratory Questionnaire (SGRQ) [3], Transition Dyspnea Index (TDI) [4], EXAcerbations of Chronic pulmonary disease Tool (EXACT) and Evalu ating Respiratory Symptoms in COPD (E-RSTM:COPD) [5,6] can be assessed in patients with COPD to determine how the disease is impacting HRQoL. We report the long-term effects of triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) vs glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF) on symptoms and health-related quality of life (HRQoL) over 52 weeks in the Phase III ETHOS study of patients with moderate-to-very severe COPD. Benefits were observed vs dual therapies in symptomatic endpoints including Transition Dyspnea Index focal score, EXAcerbations of Chronic pulmonary disease Tool total scores and Evaluating Respiratory Symptoms in COPD total scores over 24 and 52 weeks. Conclusions: BGF triple therapy improved symptoms and HRQoL vs dual therapies over 24 and 52 weeks in patients with moderate-to-very severe COPD
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