A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD
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
1 other identifier
interventional
646
4 countries
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
January 28, 2014
CompletedJanuary 11, 2017
November 1, 2016
1.4 years
June 9, 2011
December 10, 2013
November 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
fluticasone furoate/vilanterol
EXPERIMENTALInhaled corticosteroid/long acting beta-agonist
placebo
PLACEBO COMPARATORmatching placebo
Interventions
Inhaled corticosteroid/long acting beta-agonist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (34)
GSK Investigational Site
Guangzhou, Guangdong, 510120, China
GSK Investigational Site
Guangzhou, Guangdong, 510515, China
GSK Investigational Site
Nanning, Guangxi, 530021, China
GSK Investigational Site
Changsha, Hunan, 410011, China
GSK Investigational Site
Shenyang, Liaoning, 110001, China
GSK Investigational Site
Shenyang, Liaoning, 110015, China
GSK Investigational Site
Xi'an, Shaanxi, 710032, China
GSK Investigational Site
Xi'an, Shaanxi, 710061, China
GSK Investigational Site
Hangzhou, Zhejiang, 310003, China
GSK Investigational Site
Beijing, 100020, China
GSK Investigational Site
Beijing, 100034, China
GSK Investigational Site
Beijing, 100048, China
GSK Investigational Site
Beijing, 100191, China
GSK Investigational Site
Changsha, 410013, China
GSK Investigational Site
Chengdu, 610041, China
GSK Investigational Site
Chongqing, 400037, China
GSK Investigational Site
Chongqing, 400038, China
GSK Investigational Site
Shanghai, 200025, China
GSK Investigational Site
Shanghai, 200080, China
GSK Investigational Site
Shanghai, 200433, China
GSK Investigational Site
Tianjin, 300052, China
GSK Investigational Site
Quezon City, 1100, Philippines
GSK Investigational Site
Quezon City, 1109, Philippines
GSK Investigational Site
Jeonju-si, Jeollabuk-Do, 561-712, South Korea
GSK Investigational Site
Seoul, 158-710, South Korea
GSK Investigational Site
Suwon, Gyeonggi-do, 442-723, South Korea
GSK Investigational Site
Changhua, 500, Taiwan
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 40201, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taichung, 40705, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Tau-Yuan County, 333, Taiwan
Related Publications (1)
Zheng J, de Guia T, Wang-Jairaj J, Newlands AH, Wang C, Crim C, Zhong N. Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Curr Med Res Opin. 2015 Jun;31(6):1191-200. doi: 10.1185/03007995.2015.1036016.
PMID: 25830381DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 20, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 11, 2017
Results First Posted
January 28, 2014
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.