Trial intelligence / Profile preview

Efficacy and Safety of Fluticasone Furoate/Vilanterol in COPD

NCT01054885Phase 3

Key facts

Status: Completed
Start: Oct 2009
Primary completion: Feb 2011
Countries: 9
Sponsor: GSK
Modality: Orthosteric Ligands

Drugs: vilanterolfluticasone
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 3, randomised, double-blind trial of vilanterol and fluticasone in chronic obstructive pulmonary disease (COPD) (6 arms), sponsored by GSK. Primary endpoints: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 and Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169. Started Oct 2009; status: completed.

Design

6 arms

Study design: RandomizedDouble-blind

Fluticasone Furoate Inhalation Powder
Fluticasone Furoate Inhalation Powder
FF Inhalation Pwdr
Fluticasone Furoate Inhalation Powder (likely different dose)
Fluticasone Furoate/GW642444 Inhalation Powder
Fluticasone Furoate/Vilanterol Inhalation Powder
FF/GW642444 Inhalation Pwdr
Fluticasone Furoate/Vilanterol Inhalation Powder (likely different dose)
GW642444 Inhalation Powder
Vilanterol Inhalation Powder
Placebo
Placebo

Who it enrols

Patients aged 40 or older with a clinical history of COPD, >=10 pack-years smoking history, FEV1/FVC ratio <=0.70, FEV1 <=70% predicted, and mMRC score >=2. Excludes patients with asthma, other respiratory disorders, or poorly controlled COPD.

Endpoints

Primary

Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168Day 168
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169Day 169

Secondary

Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168Day 168
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1Day 1
Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1Day 1

Results

Primary endpoints met

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