NCT02603393

Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	QVA149	QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
DRUG	Tiotropium	Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®
DRUG	Salmeterol/fluticasone	Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Timeline

• Start date: 2015-11-20
• Primary completion: 2017-07-18
• Completion: 2017-07-18
• First posted: 2015-11-11
• Last updated: 2019-04-29
• Results posted: 2019-04-29

Locations

167 sites across 21 countries: Argentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Germany, Greece, Hungary, Latvia, Lithuania, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, United Kingdom