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Original Research: COPD |

Once-Daily Umeclidinium/Vilanterol 125/25 μg Therapy in COPDUmeclidinium/Vilanterol 125/25 03BCg in COPD: A Randomized, Controlled Study

Bartolome Celli, MD, FCCP; Glenn Crater, MD, FCCP; Sally Kilbride, MSc; Rashmi Mehta, PhD; Maggie Tabberer, MSc; Chris J. Kalberg, PhD; Alison Church, MD
Author and Funding Information

From the Brigham and Women’s Hospital (Dr Celli), Boston, MA; Medical Division (Dr Crater), GlaxoSmithKline, Mississauga, ON, Canada; GlaxoSmithKline (Mss Kilbride and Tabberer), Stockley Park, Uxbridge, England; and Respiratory (Drs Mehta, Kalberg, and Church), GlaxoSmithKline, Research Triangle Park, NC.

Correspondence to: Bartolome Celli, MD, FCCP, Pulmonary Division, Brigham and Women’s Hospital, 75 Francis St, PBB Clinics 3, Boston, MA 02115; e-mail: BCelli@copdnet.org


Dr Crater is currently at Clinical Development, Aerocrine (Morrisville, NC).

Funding/Support: GlaxoSmithKline funded the design/concept/conduct of the study and manuscript development.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(5):981-991. doi:10.1378/chest.13-1579
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Background:  Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in COPD. Our objectives were to compare the efficacy and safety of once-daily umeclidinium bromide (UMEC)/vilanterol (VI) 125/25 μg with placebo and UMEC or VI monotherapy in COPD.

Methods:  This was a double-blind, placebo-controlled, parallel-group study. A total of 1,493 patients were randomized (3:3:3:2) to 24 weeks of treatment with UMEC/VI 125/25 μg, UMEC 125 μg, VI 25 μg, or placebo once daily via dry powder inhaler.

Results:  Primary efficacy end point was trough FEV1 on day 169 (23-24 h postdose). Additional lung-function, symptomatic, and health-related quality-of-life end points were also assessed. Safety evaluations included adverse events, vital signs, ECG, and clinical laboratory measurements. All active treatments significantly improved trough FEV1 vs placebo (0.124-0.238 L, all P < .001). Improvements with UMEC/VI 125/25 μg were significantly greater than for UMEC 125 μg or VI 25 μg (0.079 L and 0.114 L, both P ≤ .001). Improvements for UMEC/VI 125/25 μg vs placebo were observed for the Transition Dyspnea Index (1.0 unit, P < .001), rescue albuterol use at weeks 1 to 24 (−1.5 puffs/d), and St. George’s Respiratory Questionnaire (−3.60 units, P < .001). No safety signals were observed.

Conclusions:  Once-daily UMEC/VI 125/25 μg was well tolerated and provided greater improvements in lung function, health status, and dyspnea scores compared with monotherapy components and placebo over 24 weeks. This study supports the use of UMEC/VI 125/25 μg for the maintenance treatment of COPD.

Trial registry:  ClinicalTrials.gov; No.: NCT01313637; URL: www.clinicaltrials.gov.

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