drugset / Trial / NCT00929110
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
RandomizedParallel-groupTriple-blindTreatment
Summary
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-04
- Completion
- 2011-04
Outcome
Met primary endpoint
paper At week 12, trough FEV(1) increased significantly by 97 mL with NVA237 (95% CI 64.6-130.2; p<0.001). PMID 23060624 ↗
release “GLOW2 met its primary endpoint by demonstrating NVA237 provided superior 24 -hour bronchodilation compared to p lacebo at 12 weeks” nxera.life ↗
Publications
- D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.
- Kerwin E, Hebert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012 Nov;40(5):1106-14. doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrronium | Unknown | 50 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |