A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: fluticasone furoate/vilanterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. Subject has a history of hypersensitivity to any of the study medications or components of the inhalation powder. Subject has a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded. Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening Subjects who are medically unable to withhold albuterol, ipratropium for 4 hrs and/or theophylline for 12 hrs prior to spirometry testing. Subjects use a list of prohibited medications specified in the study protocol, including but not limited to traditional or herbal medications for the treatment of COPD Subject requires long-term oxygen therapy or nocturnal oxygen therapy for greater than 12 hours a day Pulmonary rehabilitation: subjects who are in the maintenance phase are not excluded. Non-compliance Questionable validity of the Informed Consent Prior use of study medication or other investigational drugs Affiliation with investigator site

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluticasone furoate/vilanterol<br>Inhaled corticosteroid/long acting beta-agonist | Drug: fluticasone furoate/vilanterol<br>* Inhaled corticosteroid/long acting beta-agonist<br>|
| Placebo Comparator: placebo<br>matching placebo | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at 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. | Baseline to Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168 | CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions. | Baseline (BL) and Day 168 |