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 language | English |
|---|---|
| Pages (from-to) | 119-127 |
| Number of pages | 9 |
| Journal | Chest |
| Volume | 142 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2012 Jan 1 |
| Externally published | Yes |
Fingerprint
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 journal › Article
}
TY - JOUR
T1 - The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD
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
PY - 2012/1/1
Y1 - 2012/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=84858957208&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84858957208&partnerID=8YFLogxK
U2 - 10.1378/chest.11-2231
DO - 10.1378/chest.11-2231
M3 - Article
C2 - 22241764
AN - SCOPUS:84858957208
VL - 142
SP - 119
EP - 127
JO - Chest
JF - Chest
SN - 0012-3692
IS - 1
ER -