drugset / Trial / NCT01613326

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

NCT01613326 ↗

Phase 3 Completed 657 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Timeline

Start
2012-06
Primary completion
2013-01
Completion
2013-01

Outcome

Met primary endpoint

paper Least squares mean trough FEV1 for both glycopyrronium and tiotropium was 1.405 L at Week 12, meeting the criterion for non-inferiority (mean treatment difference: 0 mL, 95% CI: -32, 31 mL). PMID 24438744 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrrolate Small molecule 50 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled
Background Salbutamol Unknown — Inhaled