Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00570778 ↗

Phase 2 Completed 154 enrolled Novartis Pharmaceuticals

RandomizedCrossoverTriple-blindTreatment

Summary

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Timeline

Start: 2007-12
Primary completion: 2008-09
Completion: 2008-09

Outcome

Met primary endpoint

paper The estimated treatment difference (95% CI) for trough FEV1 on day 7 between QVA149 and placebo was 226 ml (192 to 260; p<0.001). PMID 20978028 ↗

Publications

van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glycopyrrolate	Small molecule	50 ug	Inhaled
Comparator	Indacaterol	Other / unclassified	300 ug	Inhaled
Comparator	Indacaterol	Other / unclassified	600 ug	Inhaled