A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily Via a Dry Powder Inhaler Compared With Placebo in Subjects of Asian Ancestry With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 3
- Intervention
- fluticasone furoate/vilanterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 646
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
- •Subjects of Asian ancestry
- •Valid informed consent
- •Current or former smoker
- •\> or = 2 on the modified Medical Research Council Dyspnea Scale at Screening
Exclusion Criteria
- •Pregnancy
- •A current diagnosis of asthma
- •alpha1-antitrypsin deficiency as the underlying cause for COPD
- •Other active, respiratory disorders
- •Have lung volume reduction surgery within 12 months prior to Screening
- •A chest X-ray or CT (Computerised Tomography) scan reveals evidence of clinical significant abnormalities not believed to be due to the presence of COPD
- •Poorly controlled COPD: acute worsening of COPD managed by corticosteroids, antibiotics, or treatments prescribed by a physician 6 weeks prior to Screening, or requires hospitalisation due to poorly controlled COPD 12 weeks prior to Screening
- •Lower respiratory tract infection requires antibiotics within 4 weeks prior to Screening
- •Other disease or abnormalities, in the opinion of the investigator, would put the safety of the subject at risk during the study or would affect safety or efficacy analysis if the disease/condition exacerbated during the study
- •Subject with carcinoma that has not been in complete remission for at least 5 years, carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
Arms & Interventions
fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Intervention: fluticasone furoate/vilanterol
placebo
matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
Time Frame: Baseline to Day 169
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.
Secondary Outcomes
- Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168(Baseline (BL) and Day 168)