The Efficacy and Safety of the Novel Long-Acting beta(2) Agonist Vilanterol in Patients With COPD A Randomized Placebo-Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | Hanania, Nicola A. | - |
dc.contributor.author | Feldman, Gregory | - |
dc.contributor.author | Zachgo, Wolfgang | - |
dc.contributor.author | Shim, Jae-Jeong | - |
dc.contributor.author | Crim, Courtney | - |
dc.contributor.author | Sanford, Lisa | - |
dc.contributor.author | Lettis, Sally | - |
dc.contributor.author | Barnhart, Frank | - |
dc.contributor.author | Haumann, Brett | - |
dc.date.accessioned | 2021-09-06T18:12:01Z | - |
dc.date.available | 2021-09-06T18:12:01Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2012-07 | - |
dc.identifier.issn | 0012-3692 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/108068 | - |
dc.description.abstract | Background: Vilanterol (GW642444M) (VI) is a novel, inhaled, long-acting beta(2) 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 mu g 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 mu g 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-mu g 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 mu g 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 CHEST 2012; 142(1):119-127 | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER | - |
dc.title | The Efficacy and Safety of the Novel Long-Acting beta(2) Agonist Vilanterol in Patients With COPD A Randomized Placebo-Controlled Trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Shim, Jae-Jeong | - |
dc.identifier.doi | 10.1378/chest.11-2231 | - |
dc.identifier.wosid | 000306209800021 | - |
dc.identifier.bibliographicCitation | CHEST, v.142, no.1, pp.119 - 127 | - |
dc.relation.isPartOf | CHEST | - |
dc.citation.title | CHEST | - |
dc.citation.volume | 142 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 119 | - |
dc.citation.endPage | 127 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalResearchArea | Respiratory System | - |
dc.relation.journalWebOfScienceCategory | Critical Care Medicine | - |
dc.relation.journalWebOfScienceCategory | Respiratory System | - |
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