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Open Access 01-06-2016 | Original Research Article

Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Authors: Chris Kalberg, Dianne O’Dell, Dmitry Galkin, Amy Newlands, William A. Fahy

Published in: Drugs in R&D | Issue 2/2016

Abstract

Introduction

The fixed-dose, long-acting bronchodilator combination of umeclidinium/vilanterol (UMEC/VI) has not previously been compared with a combination of a long-acting muscarinic antagonist and long-acting β₂-agonist in patients with chronic obstructive pulmonary disease (COPD).

Methods

This 12-week, randomized, blinded, triple-dummy, parallel-group, non-inferiority study compared once-daily UMEC/VI 62.5/25 mcg with once-daily tiotropium (TIO) 18 mcg + indacaterol (IND) 150 mcg in patients with moderate-to-very-severe COPD. The primary endpoint was the trough forced expiratory volume in 1 s (FEV₁) on day 85 (predefined non-inferiority margin −50 mL), and the secondary endpoint was the 0- to 6-h weighted mean (WM) FEV₁ on day 84. Other efficacy endpoints [including rescue medication use, the Transition Dyspnea Index (TDI) focal score, and the St. George’s Respiratory Questionnaire (SGRQ) score] and safety endpoints [adverse events (AEs), vital signs, and COPD exacerbations] were also assessed.

Results

Trough FEV₁ improvements were comparable between treatment groups [least squares (LS) mean changes from baseline to day 85: UMEC/VI 172 mL; TIO + IND 171 mL; treatment difference 1 mL; 95 % confidence interval (CI) −29 to 30 mL], demonstrating non-inferiority between UMEC/VI and TIO + IND. The treatments produced similar improvements in the trough FEV₁ at other study visits and the 0- to 6-h WM FEV₁ (LS mean changes at day 84: UMEC/VI 235 mL; TIO + IND 258 mL; treatment difference −23 mL; 95 % CI −54 to 8 mL). The results for patient-reported measures (rescue medication use, TDI focal score, and SGRQ score) were comparable; both treatments produced clinically meaningful improvements in TDI and SGRQ scores. The incidence of AEs and COPD exacerbations, and changes in vital signs were similar for the two treatments.

Conclusion

UMEC/VI and TIO + IND, given once daily, provided similar improvements in lung function and patient-reported outcomes over 12 weeks in patients with COPD, with comparable tolerability and safety profiles.

Trial numbers

ClinicalTrials.gov study ID NCT02257385; GSK study no. 116961.

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Title: Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Authors: Chris Kalberg
Dianne O’Dell
Dmitry Galkin
Amy Newlands
William A. Fahy
Publication date: 01-06-2016
Publisher: Springer International Publishing
Published in: Drugs in R&D / Issue 2/2016
Print ISSN: 1174-5886
Electronic ISSN: 1179-6901
DOI: https://doi.org/10.1007/s40268-016-0131-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Dual Bronchodilator Therapy with Umeclidinium/Vilanterol Versus Tiotropium plus Indacaterol in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Abstract

Introduction

Methods

Results

Conclusion

Trial numbers

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

Trial numbers

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