drugset / Trial / NCT01757015

Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS

NCT01757015

Phase 3 Withdrawn Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).

Timeline

Start
2013-04
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrrolate Small molecule 50 ug Inhaled