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Original Research |

The Efficacy and Safety of the Novel Long-Acting β2 Agonist Vilanterol in Patients With COPDClinical Efficacy in COPD of Once-Daily Vilanterol: A Randomized Placebo-Controlled Trial

Nicola A. Hanania, MD, FCCP; Gregory Feldman, MD; Wolfgang Zachgo, MD; Jae-Jeong Shim, MD, PhD; Courtney Crim, MD, FCCP; Lisa Sanford, MSc; Sally Lettis, PhD; Frank Barnhart, DVM; Brett Haumann, MD
Author and Funding Information

From the Section of Pulmonary and Critical Care (Dr Hanania), Baylor College of Medicine, Houston, TX; S. Carolina Pharmaceutical Research (Dr Feldman), Spartanburg, SC; Pneumologisches Forschungsinstitut Hohegeest (Dr Zachgo), Geesthacht, Germany; the Department of Pulmonology, Allergy, and Critical Care Medicine (Dr Shim), Guro Hospital, Seoul, South Korea; the Respiratory and Medicines Development Center (Drs Crim and Barnhart), GlaxoSmithKline, Research Triangle Park, NC; and the Respiratory and Medicines Development Centre (Ms Sanford and Drs Lettis and Haumann), GlaxoSmithKline, Uxbridge, England.

Correspondence to: Nicola A. Hanania, MD, FCCP, Section of Pulmonary and Critical Care, Baylor College of Medicine, 1504 Taub Loop, Houston, TX 77030; e-mail: hanania@bcm.tmc.edu

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Hanania has received fees from GlaxoSmithKline for participation in the speakers bureau and on the National Advisory Board of GlaxoSmithKline; his institution has received remuneration for participation in clinical trials sponsored by GlaxoSmithKline. Dr Feldman has received funds as the principle investigator in a clinical trial sponsored by GlaxoSmithKline, which was administered by his employer, S. Carolina Pharmaceutical Research. Dr Zachgo has received lecture fees from GlaxoSmithKline; he has participated in clinical research studies sponsored by GlaxoSmithKline, Novartis AG, Boehringer Ingelheim, Nycomed, and AstraZeneca. Dr Shim has received funds for his participation in a clinical trial sponsored by GlaxoSmithKline, which was administered by his employer, Guro Hospital, Seoul, South Korea. Drs Crim, Lettis, Barnhart, and Haumann and Ms Sanford are employees of and hold stocks in GlaxoSmithKline.

Role of sponsors: The charge for color figures was paid for by GlaxoSmithKline. Editorial support in the form of development of draft outline, development of manuscript first draft, editorial suggestions to draft versions of this paper, assembling tables and figures, collating author comments, copyediting, fact checking, referencing and graphic services was provided by David Cutler at Gardiner-Caldwell Communications and was funded by GlaxoSmithKline.

Funding/Support: This study was funded by GlaxoSmithKline.


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

Funding/Support: This study was funded by GlaxoSmithKline.


Chest. 2012;142(1):119-127. doi:10.1378/chest.11-2231
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Background:  Vilanterol (GW642444M) (VI) is a novel, inhaled, long-acting β2 agonist with inherent 24-h activity under development as a once-daily combination therapy with an inhaled corticosteroid for COPD and asthma. This study assessed the dose response, efficacy, and safety of VI at doses of 3 to 50 μg in patients with moderate to severe COPD.

Methods:  Six hundred two patients (intent-to-treat) were randomized (double-blind) to VI 3, 6.25, 12.5, 25, or 50 μg or placebo once daily for 28 days. The primary end point was change from baseline in trough FEV1 at the end of the 28-day treatment period. Secondary end points included 0- to 24-h weighted mean FEV1 on days 1 and 28 and time to increases of ≥ 100 mL or ≥ 12% from baseline FEV1 on day 1. Safety assessments included adverse events, vital signs, ECG assessment, and clinical laboratory tests.

Results:  VI once daily for 28 days significantly improved trough FEV1 in a dose-dependent manner vs placebo. Clinically relevant treatment differences of ≥ 130 mL in trough and 0- to 24-h weighted mean FEV1 were observed with VI 25- and 50-μg doses vs placebo. All doses of VI were associated with a low incidence of treatment-related adverse events/serious adverse events, with no suggestion of effects on BP, pulse rate, QT intervals corrected for heart rate calculated by Fridericia formula, or blood glucose and potassium levels.

Conclusions:  VI 25 and 50 μg once daily provided both statistically and clinically relevant 24-h improvements in lung function in patients with COPD compared with placebo. All doses of VI had a safety and tolerability profile similar to placebo.

Trial registry:  ClinicalTrials.gov; No.: NCT00606684; URL: www.clinicaltrials.gov

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