Pulmonary Disease, Chronic ObstructivePhase 3NCT01323634

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg and Fluticasone Propionate 250mcg/ salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 50 sites in 6 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 this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with 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 100mcg / GW642444 (vilanterol) 25mcg and Fluticasone Propionate 250mcg/ salmeterol 50mcg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 519 participants
Where: 50 sitesin 6 countries
Study dates: 18 Mar 2011to 14 Dec 2011
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

Signed and dated written informed consent
Male or females ≥ 40 years of age
Established clinical history of COPD by ATS/ERS definition
Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
Former or current smoker > 10 pack years
Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)

Who cannot join

Current diagnosis of asthma
Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung volume reduction surgery within previous 12 months
Clinically significant abnormalities not due to COPD by chest x-ray
Hospitalized for poorly controlled COPD within 12 weeks of Screening
Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician

Show all 19Show fewer

Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
Carcinoma not in complete remission for at least 5 years
Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation
Known/suspected history of alcohol or drug abuse in the last 2 years
Women who are pregnant or lactating or plan to become pregnant
Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
Non-compliance or inability to comply with study procedures or scheduled visits
Affiliation with investigator site

Trial locations and contacts

50 sites in 6 countries.

Country

City, postcode or hospital

50 sites in 6 countries

United States12 sites

GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
Orlando, Florida, 32822
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Waco, Texas, 76712

Other trials in United States

Romania10 sites

GSK Investigational Site
Brasov, 500112
GSK Investigational Site
Brasov, 500283
GSK Investigational Site
Bucharest, 011794
GSK Investigational Site
Bucharest, 030317
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Bucharest, 70000
GSK Investigational Site
Cluj-Napoca, 400371
GSK Investigational Site
Iași, 700115
GSK Investigational Site
Suceava, 720284
GSK Investigational Site
Timișoara, 300310

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Czechia8 sites

GSK Investigational Site
Benešov, 256 30
GSK Investigational Site
Blansko, 678 31
GSK Investigational Site
Kroměříž, 767 55
GSK Investigational Site
Kyjov, 697 33
GSK Investigational Site
Mělník, 276 01
GSK Investigational Site
Nový Jičín, 741 01
GSK Investigational Site
Rokycany, 337 01
GSK Investigational Site
Třebíč, 674 01

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Poland7 sites

GSK Investigational Site
Działdowo, 13-200
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Inowrocław, 88-100
GSK Investigational Site
Katowice, 40-018
GSK Investigational Site
Krakow, 31-159
GSK Investigational Site
Poznan, 60-214
GSK Investigational Site
Wroclaw, 54-239

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Russia7 sites

GSK Investigational Site
Barnaul, 656024
GSK Investigational Site
Barnaul, 656038
GSK Investigational Site
Kaluga, 248007
GSK Investigational Site
Kemerovo, 650002
GSK Investigational Site
Kursk, 305035
GSK Investigational Site
Moscow, 125367
GSK Investigational Site
Saint Petersburg, 194291

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Germany6 sites

GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 14057
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Wiesbaden, Hesse, 65183

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About this study

Official title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Read the detailed description

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg/ salmeterol 50mcg
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 100mcg / GW642444 (vilanterol) 25mcgDrug
inhalation powder
Fluticasone Propionate 250mcg/ salmeterol 50mcgDrug
inhalation powder

Study groups in NCT01323634
Study group	Role	What they receive
Fluticasone Furoate / GW642444 (vilanterol)	Experimental	Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) Receives: Drug: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg
Fluticasone Propionate / salmeterol	Active comparator	Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) Receives: Drug: Fluticasone Propionate 250mcg/ salmeterol 50mcg

What is being measured

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

Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
Measured: Baseline (Day 1) and Day 84

Secondary outcomes (1)

Time to Onset on Treatment Day 1
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
Measured: Day 1

Timeline

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

18 Mar 201114 Dec 2011

First posted25 Mar 2011 (estimated)
Study start18 Mar 2011
Primary completion14 Dec 2011
Study completion14 Dec 2011

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: 519 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323634
Sponsor's protocol ID: 113109
Status last verified: Oct 2017
First submitted: 17 Mar 2011
Last updated: 8 Nov 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

Dransfield MT, Feldman G, Korenblat P, LaForce CF, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171-9. doi: 10.1016/j.rmed.2014.05.008. Epub 2014 Jun 19.
PubMed 24998880

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 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01323634
Acronym / sponsor ID: 113109
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 519 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Mar 2011 (actual)
Primary completion: 14 Dec 2011 (actual)
Study completion: 14 Dec 2011 (actual)
First posted: 25 Mar 2011 (estimated)
Results: Posted 30 Jul 2013

Clinical summary

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

Detailed description

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 / GW642444 (vilanterol)	Experimental	Drug: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcgInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Fluticasone Propionate / salmeterol	Active comparator	Drug: Fluticasone Propionate 250mcg/ salmeterol 50mcgInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)

Who may qualify

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

Key inclusion criteria (6 listed)

Signed and dated written informed consent
Male or females ≥ 40 years of age
Established clinical history of COPD by ATS/ERS definition
Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
Former or current smoker > 10 pack years

Key exclusion criteria (19 listed)

Current diagnosis of asthma
Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung volume reduction surgery within previous 12 months
Clinically significant abnormalities not due to COPD by chest x-ray
Hospitalized for poorly controlled COPD within 12 weeks of 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 100mcg / GW642444 (vilanterol) 25mcginhalation powder	Drug	Fluticasone Furoate / GW642444 (vilanterol)
Fluticasone Propionate 250mcg/ salmeterol 50mcginhalation powder	Drug	Fluticasone Propionate / salmeterol

Primary outcome

Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Time frame: Baseline (Day 1) and Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.

1 secondary outcome

Time to Onset on Treatment Day 1
Time frame: Day 1

Results and safety

Results posted to the registry on 30 Jul 2013, 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 + Salbutamol	733	521
FSC 250/50 µg BID	0	0
FF/VI 100/25 µg QD	0	0

Primary outcome: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84

Time frame: Baseline (Day 1) and Day 84. Least squares mean (Standard Error). Unit: Liters

Measure	FSC 250/50 µg BID n = 213	FF/VI 100/25 µg QD n = 228
Value	0.094 (0.0158)	0.174 (0.0153)

FSC 250/50 µg BID vs FF/VI 100/25 µg QD: Least square mean difference: 0.080 (95% CI 0.037 to 0.124), p <0.001, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only participants available at the indicated time point were assessed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious adverse events were collected from Baseline to the end of the study (up to 12 weeks).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FSC 250/50 µg BID	8 of 259 (3.1%)	18 of 259 (6.9%)	Not reported
FF/VI 100/25 µg QD	3 of 260 (1.2%)	23 of 260 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24998880Dransfield MT, Feldman G, Korenblat P, LaForce CF, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171-9. doi: 10.1016/j.rmed.2014.05.008. Epub 2014 Jun 19.
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

50 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 19 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Romania, Czechia, Poland, Russia and 1 more country. 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. 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 30 Jul 2013). 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?

Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (time frame: Baseline (Day 1) and Day 84). 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 NCT01323634, 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 8 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.