drugset / Trial / NCT01922271

Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01922271 ↗

Phase 4 Completed 152 enrolled Novartis Pharmaceuticals
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.

Timeline

Start
2013-08
Primary completion
2014-01
Completion
2014-01

Outcome

Met primary endpoint

paper Glycopyrronium was superior to tiotropium in terms of early bronchodilation. PMID 27940287 ↗

paper FEV1 AUC0-2h (least squares mean treatment difference = 37 mL; 95% CI: 16, 59 mL; p < 0.01) PMID 27940287 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrrolate Small molecule 44 ug Inhaled
Subject Tiotropium Other / unclassified 18 ug Inhaled
Background Salbutamol Unknown — —