Chest
Original ResearchCOPDThe Efficacy and Safety of the Novel Long-Acting β2 Agonist Vilanterol in Patients With COPD: A Randomized Placebo-Controlled Trial
Section snippets
Study Population
Men and women aged 40 to 80 years with a history of COPD and ≥ 10 pack-years of smoking were enrolled. At screening, eligible patients had a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤ 0.70 and an FEV1 of ≥ 35% and ≤ 70% of predicted.
Medications not permitted during the study are detailed in e-Table 1. Reasons for exclusion included current diagnosis of asthma, α1-antitrypsin deficiency, and receipt of long-term oxygen therapy. Complete inclusion/exclusion criteria are detailed in
Study Population
A total of 605 patients were randomized; the ITT population comprised 602 patients, and 539 (90%) completed the study (Fig 1). The primary reasons for withdrawing early from the study were protocol deviation (n = 20), AE (n = 12), investigator discretion (n = 12), or reaching protocol-defined withdrawal criteria (n = 10).
Baseline demographic and clinical characteristics were similar across treatment groups (Table 1). The majority of patients in each treatment group were male, white, and graded
Discussion
Our study demonstrates that the novel long-acting β2 agonist VI is effective and well tolerated in patients with COPD. Treatment with VI once daily at doses ranging from 3 μg to 50 μg for 28 days produced statistically significant, dose-dependent improvements in trough FEV1 (primary outcome measure) compared with placebo. An improvement from baseline FEV1 of ≥ 100 mL represents a clinically relevant treatment difference.11 Adjusted mean treatment differences of ≥ 100 mL vs placebo in both
Acknowledgments
Author contributions: All authors vouch for the accuracy and completeness of the data and the data analysis.
Dr Hanania: contributed as a study principal investigator, had full access to and interpreted the data, and wrote the manuscript.
Dr Feldman: contributed as a study principal investigator, had full access to and interpreted the data, and wrote the manuscript.
Dr Zachgo: contributed as a study principal investigator, had full access to and interpreted the data, and wrote the manuscript.
Dr
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Funding/Support: This study was funded by GlaxoSmithKline.