The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: A randomized placebo-controlled trial

Nicola A. Hanania, Gregory Feldman, Wolfgang Zachgo, Jae Jeong Shim, Courtney Crim, Lisa Sanford, Sally Lettis, Frank Barnhart, Brett Haumann

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

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 FEV 1 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.

Original languageEnglish
Pages (from-to)119-127
Number of pages9
JournalChest
Volume142
Issue number1
DOIs
Publication statusPublished - 2012 Jan 1
Externally publishedYes

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Chronic Obstructive Pulmonary Disease
Randomized Controlled Trials
Placebos
Safety
Heart Rate
Vital Signs
Therapeutics
Registries
Blood Glucose
Potassium
Adrenal Cortex Hormones
Electrocardiography
Asthma
vilanterol
Lung
Incidence

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD : A randomized placebo-controlled trial. / Hanania, Nicola A.; Feldman, Gregory; Zachgo, Wolfgang; Shim, Jae Jeong; Crim, Courtney; Sanford, Lisa; Lettis, Sally; Barnhart, Frank; Haumann, Brett.

In: Chest, Vol. 142, No. 1, 01.01.2012, p. 119-127.

Research output: Contribution to journalArticle

Hanania, NA, Feldman, G, Zachgo, W, Shim, JJ, Crim, C, Sanford, L, Lettis, S, Barnhart, F & Haumann, B 2012, 'The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: A randomized placebo-controlled trial', Chest, vol. 142, no. 1, pp. 119-127. https://doi.org/10.1378/chest.11-2231
Hanania, Nicola A. ; Feldman, Gregory ; Zachgo, Wolfgang ; Shim, Jae Jeong ; Crim, Courtney ; Sanford, Lisa ; Lettis, Sally ; Barnhart, Frank ; Haumann, Brett. / The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD : A randomized placebo-controlled trial. In: Chest. 2012 ; Vol. 142, No. 1. pp. 119-127.
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T2 - A randomized placebo-controlled trial

AU - Hanania, Nicola A.

AU - Feldman, Gregory

AU - Zachgo, Wolfgang

AU - Shim, Jae Jeong

AU - Crim, Courtney

AU - Sanford, Lisa

AU - Lettis, Sally

AU - Barnhart, Frank

AU - Haumann, Brett

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N2 - 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 FEV 1 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.

AB - 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 FEV 1 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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