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Efficacy of Umeclidinium Added to Fluticasone/Salmeterol in COPD
NCT01772134Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2013
- Primary completion
- Jul 2013
- Countries
- 4
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- umeclidinium
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised, double-blind trial of umeclidinium in chronic obstructive pulmonary disease (COPD) (3 arms), sponsored by GSK. Primary endpoint: Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85. Started Jan 2013; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Umeclidinium 62.5 + FP/SAL
Umeclidinium bromide 62.5mcg + Fluticasone propionate 250mcg/Salmeterol 50mcg
Umeclidinium 125 + FP/SAL
Umeclidinium bromide 125mcg + Fluticasone propionate 250mcg/Salmeterol 50mcg
Placebo + FP/SAL
Placebo + Fluticasone propionate 250mcg/Salmeterol 50mcg
03
Who it enrols
Patients 40 years or older with a clinical history of COPD, >=10 pack-year smoking history, FEV1/FVC < 0.70, FEV1 <= 70% predicted, and mMRC score >= 2. Patients with asthma or other significant respiratory conditions are excluded.
04
Endpoints
Primary
Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85
Secondary
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84
Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12
05
Results
Primary endpoints met
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