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FF/VI vs Tiotropium in COPD with Cardiovascular Risk
NCT01627327Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2012
- Primary completion
- Dec 2012
- Countries
- 6
- Sponsor
- GSK
- Modality
- Orthosteric Ligands
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised, double-blind trial of fluticasone and vilanterol in chronic obstructive pulmonary disease (COPD) (2 arms), sponsored by GSK. Primary endpoint: Change From Baseline Trough in 24-hour Weighted Mean Forced Expiratory Volume in 1 Second at 12 weeks. Started Apr 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Fluticasone Furoate/Vilanterol
FF/VI 100/25mcg once daily via DPI + Placebo via HandiHaler
Tiotropium Bromide
Tiotropium 18mcg once daily via HandiHaler + Placebo via DPI
03
Endpoints
Primary
Change From Baseline Trough in 24-hour Weighted Mean Forced Expiratory Volume in 1 Second
Secondary
Time to Onset of Action
Change From Baseline in Trough Forced Expiratory Volume in 1 Second
04
Results
Not all primary endpoints met
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