Pulmonary Disease, Chronic ObstructivePhase 3NCT01376245

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

A Phase 3 study testing fluticasone furoate/vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 34 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: fluticasone furoate/vilanterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 646 participants
Where: 34 sitesin 4 countries
Study dates: Apr 2011to Sep 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

34 sites in 4 countries.

Country

City, postcode or hospital

34 sites in 4 countries

China21 sites

GSK Investigational Site
Beijing, 100020
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100048
GSK Investigational Site
Beijing, 100191
GSK Investigational Site
Changsha, Hunan, 410011
GSK Investigational Site
Changsha, 410013
GSK Investigational Site
Chengdu, 610041
GSK Investigational Site
Chongqing, 400037
GSK Investigational Site
Chongqing, 400038
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Guangzhou, Guangdong, 510515
GSK Investigational Site
Hangzhou, Zhejiang, 310003
GSK Investigational Site
Nanning, Guangxi, 530021
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200080
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Shenyang, Liaoning, 110001
GSK Investigational Site
Shenyang, Liaoning, 110015
GSK Investigational Site
Tianjin, 300052
GSK Investigational Site
Xi'an, Shaanxi, 710032
GSK Investigational Site
Xi'an, Shaanxi, 710061

Other trials in China

Taiwan8 sites

GSK Investigational Site
Changhua, 500
GSK Investigational Site
Kaohsiung City, 833
GSK Investigational Site
Taichung, 40201
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taichung, 40705
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Tau-Yuan County, 333

Other trials in Taiwan

South Korea3 sites

GSK Investigational Site
Jeonju-si, Jeollabuk-Do, 561-712
GSK Investigational Site
Seoul, 158-710
GSK Investigational Site
Suwon, Gyeonggi-do, 442-723

Other trials in South Korea

Philippines2 sites

GSK Investigational Site
Quezon City, 1100
GSK Investigational Site
Quezon City, 1109

Other trials in Philippines

About this study

Official title: 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: Pulmonary Disease, Chronic Obstructive
Being tested: fluticasone furoate/vilanterol, Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fluticasone furoate/vilanterolDrug
Inhaled corticosteroid/long acting beta-agonist
PlaceboDrug
matching placebo

Study groups in NCT01376245
Study group	Role	What they receive
fluticasone furoate/vilanterol	Experimental	Inhaled corticosteroid/long acting beta-agonist Receives: Drug: fluticasone furoate/vilanterol
placebo	Placebo comparator	matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Baseline (BL) and Day 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Sep 2012

First posted20 Jun 2011 (estimated)
Study startApr 2011
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 646 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01376245
Sponsor's protocol ID: 113684
Status last verified: Nov 2016
First submitted: 9 Jun 2011
Last updated: 11 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 25830381

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01376245
Acronym / sponsor ID: 113684
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 646 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 20 Jun 2011 (estimated)
Results: Posted 28 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
fluticasone furoate/vilanterol	Experimental	Drug: fluticasone furoate/vilanterolInhaled corticosteroid/long acting beta-agonist
placebo	Placebo comparator	Drug: Placebomatching placebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fluticasone furoate/vilanterolInhaled corticosteroid/long acting beta-agonist	Drug	fluticasone furoate/vilanterol
Placebomatching placebo	Drug	placebo

Primary outcome

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.

1 secondary outcome

Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
Time frame: Baseline (BL) and Day 168

Results and safety

Results posted to the registry on 28 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo- Run-in	744	643
Placebo	0	0
FF /VI 50/25 µg OD	0	0
FF/VI 100/25 µg OD	0	0
FF/VI 200/25 µg OD	0	0

Primary outcome: Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169

Time frame: Baseline to Day 169. Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 126	FF/VI 50/25 µg OD n = 134	FF/VI 100/25 µg OD n = 136	FF/VI 200/25 µg OD n = 131
Value	-0.027 (0.0184)	0.113 (0.0183)	0.152 (0.0181)	0.167 (0.0182)

Placebo vs FF/VI 50/25 µg OD: Least Squares Mean Difference: 0.140 (95% CI 0.089 to 0.191), p <0.001, Mixed Models Analysis
Placebo vs FF/VI 100/25 µg OD: Least Squares Mean Difference: 0.179 (95% CI 0.129 to 0.230), p <0.001, Mixed Models Analysis
Placebo vs FF/VI 200/25 µg OD: Least Squares Mean Difference: 0.194 (95% CI 0.143 to 0.245), p <0.001, Mixed Models Analysis

Population analysed: Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	14 of 162 (8.6%)	27 of 162 (16.7%)	Not reported
FF/VI 50/25 µg OD	9 of 160 (5.6%)	33 of 160 (20.6%)	Not reported
FF/VI 100/25 µg OD	7 of 161 (4.3%)	34 of 161 (21.1%)	Not reported
FF/VI 200/25 µg OD	14 of 160 (8.8%)	40 of 160 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25830381Zheng 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

34 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluticasone furoate/vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 34 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, Taiwan, South Korea, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169 (time frame: Baseline to Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01376245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.