Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3 Completed 108 enrolled Novartis Pharmaceuticals

RandomizedCrossoverDouble-blindTreatment

Summary

The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

Timeline

Start: 2010-06
Primary completion: 2011-02
Completion: 2011-02

Outcome

Met primary endpoint

paper On Day 21, a 21% difference in endurance time was observed between patients treated with NVA237 and those treated with placebo (P < 0.001); PMID 22973092 ↗

paper NVA237 50 μg once daily produced immediate and significant improvement in exercise tolerance from Day 1. PMID 22973092 ↗

release “GLOW3試験では、NVA237（１日１回投与、50μg）の運動耐容能に対する効果が評価され、試験終了時（21日目）に、NVA237はプラセボに対して21%の運動耐容能の改善を示し、主要評価項目を達成しました” nxera.life ↗

Publications

Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012;7:503-13. doi: 10.2147/COPD.S32451. Epub 2012 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glycopyrrolate	Small molecule	50 ug	Inhaled