drugset / Trial / NCT01757015
Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 50 ug | Inhaled |