Pulmonary Disease, Chronic ObstructivePhase 3NCT01336608

A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD

A Phase 3 study testing Fluticasone Furoate/Vilanterol and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 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 the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above. 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 and Vilanterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 446 participants
Where: 72 sitesin 6 countries
Study dates: 4 Mar 2011to 4 Nov 2014
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 defined by ATS/ERS
Former or current smoker
A measured aortic pulse wave velocity = or > 11.0 m/s at Screening

Who cannot join

Pregnancy
A current diagnosis of asthma
alpha1-antitrypsin deficiency as the underlying cause of COPD
subjects with other and active respiratory disorders
A cardiovascular event occurred in the 6 months prior to Visit 1
Current severe heart failure (New York Heart Association Class IV) and have a known ejection fraction of < 30 %

Show all 26Show fewer

Clinical significant and uncontrolled hypertension
Abnormal and clinical significant 12-lead ECG findings at Visit 1
Have lung volume reduction or lung transplantation within 12 months prior to Visit 1
Poorly controlled COPD: Acute worsening of COPD that is managed by subject with antibiotics or corticosteroids, or requires treatment prescribed by a physician in the 6 weeks prior to Visit 1; or subject needs to be hospitalised due to poorly controlled COPD within 12 weeks prior to Visit 1
Lower respiratory tract infection that required use of antibiotics within 6 weeks prior to Visit 1
Participate in the acute phase of a pulmonary rehabilitation within 4 weeks prior to Visit 1 or who will enter the acute phase of pulmonary rehabilitation during the study.
Other diseases or abnormalities in the opinion of the investigator would put safety of the subject at risk through participation; or would affect the safety or efficacy analysis if the disease/condition exacerbated during the study.
subjects with carcinoma has not been in complete remission for at least 5 years. Carcinoma in site 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.
subjects with a history of hypersensitivity to any of the study medications or components of the inhalation powder.
subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
subjects are medically unable to withhold albuterol or ipratropium for 4 hours prior to spirometry testing at each study visit
subjects are medically unable to stop the 'excluded medications' listed in the protocol
subjects started, discontinued certain medications listed in the protocol or have not been on a stable dose in the past three months prior to Screening, or are not anticipated to remain on a stable dose during the study treatment period.
Long term oxygen therapy requiring >12 hour per day or a flow rate > 2 L/min
A body mass index = or >35 kg/m2
Fasting lipid level LDL>3.3 mmol/L, total cholesterol >5.2 mmol/L, and triglycerides > 2.24mmol/L
Non-compliance
Questionable validity of consent
Prior use of study medication or other investigational drugs.
Affiliation with investigator site

Trial locations and contacts

72 sites in 6 countries.

Country

City, postcode or hospital

72 sites in 6 countries

United States36 sites

GSK Investigational Site
Abingdon, Virginia, 24210
GSK Investigational Site
Avon, Indiana, 46123
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Duluth, Georgia, 30096
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Edinburg, Texas, 78539
GSK Investigational Site
Fort Mill, South Carolina, 29707
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Lafayette, Indiana, 47904
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Muncie, Indiana, 47304-5547
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Orlando, Florida, 32825
GSK Investigational Site
Ormond Beach, Florida, 32174
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Seneca, South Carolina, 29678
GSK Investigational Site
Shelby, North Carolina, 28152
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Traverse City, Michigan, 49684
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Winter Park, Florida, 32789

Other trials in United States

Germany11 sites

GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 10789
GSK Investigational Site
Dresden, Saxony, 01069
GSK Investigational Site
Elsterwerda, Brandenburg, 04910
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Hamburg, 20253
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112

Other trials in Germany

South Korea8 sites

GSK Investigational Site
Ansan, 425-707
GSK Investigational Site
Gwangju, 501-757
GSK Investigational Site
Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411706
GSK Investigational Site
Pusan, 614-735
GSK Investigational Site
Seoul, 134-090
GSK Investigational Site
Seoul, 134060
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Seoul, 152-703

Other trials in South Korea

Thailand7 sites

GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Muang, 11000
GSK Investigational Site
Muang, 65000
GSK Investigational Site
Nan, 55000

Other trials in Thailand

Philippines6 sites

GSK Investigational Site
Dagupan, 2400
GSK Investigational Site
Jaro, Iloilo City, 5000
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Marilao, Bulacan, 3019
GSK Investigational Site
Pasig, 1600
GSK Investigational Site
Quezon City, 1100

Other trials in Philippines

Norway4 sites

GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Kløfta, 2040
GSK Investigational Site
Moss, 1501
GSK Investigational Site
Stavanger, 4005

Other trials in Norway

About this study

Official title: A 24-week Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder Delivered Once-daily Via a Novel Dry Powder Inhaler on Arterial Stiffness Compared With Placebo and Vilanterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Fluticasone Furoate/Vilanterol, 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
VilanterolDrug
Inhaled long acting beta-agonist
PlaceboDrug
Placebo

Study groups in NCT01336608
Study group	Role	What they receive
Fluticasone Furoate/Vilanterol	Experimental	Inhaled corticosteroid/long acting beta-agonist Receives: Drug: Fluticasone Furoate/Vilanterol
vilanterol	Experimental	Inhaled long acting beta-agonist Receives: Drug: Vilanterol
placebo	Placebo comparator	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 (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)
PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.
Measured: BL to Day 168

Secondary outcomes (2)

Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.
Measured: BL to Day 168
Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period
Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.
Measured: BL (Week -1), Week 1 to Week 24

Timeline

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

4 Mar 20114 Nov 2014

First posted18 Apr 2011 (estimated)
Study start4 Mar 2011
Primary completion4 Nov 2014
Study completion4 Nov 2014

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.
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: 446 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01336608
Sponsor's protocol ID: 113108
Status last verified: Oct 2017
First submitted: 31 Mar 2011
Last updated: 8 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
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.

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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All Pulmonary Disease, Chronic Obstructive trials

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 24-week Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder Delivered Once-daily Via a Novel Dry Powder Inhaler on Arterial Stiffness Compared With Placebo and Vilanterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
ClinicalTrials.gov ID: NCT01336608
Acronym / sponsor ID: 113108
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 446 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Mar 2011 (actual)
Primary completion: 4 Nov 2014 (actual)
Study completion: 4 Nov 2014 (actual)
First posted: 18 Apr 2011 (estimated)
Results: Posted 10 Jul 2015

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: 3

Arm	Type	Receives
Fluticasone Furoate/Vilanterol	Experimental	Drug: Fluticasone Furoate/VilanterolInhaled corticosteroid/long acting beta-agonist
vilanterol	Experimental	Drug: VilanterolInhaled long acting beta-agonist
placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (3 listed)

COPD diagnosis defined by ATS/ERS
Former or current smoker
A measured aortic pulse wave velocity = or > 11.0 m/s at Screening

Key exclusion criteria (26 listed)

Pregnancy
A current diagnosis of asthma
alpha1-antitrypsin deficiency as the underlying cause of COPD
subjects with other and active respiratory disorders
A cardiovascular event occurred in the 6 months prior to Visit 1

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
VilanterolInhaled long acting beta-agonist	Drug	vilanterol
PlaceboPlacebo	Drug	placebo

Primary outcome

Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)
Time frame: BL to Day 168
PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.

2 secondary outcomes

Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168
Time frame: BL to Day 168
Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period
Time frame: BL (Week -1), Week 1 to Week 24

Results and safety

Results posted to the registry on 10 Jul 2015, 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	559	444
Placebo QD	0	0
VI 25 µg QD	0	0
FF/VI 100/25 µg QD	0	0

Primary outcome: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)

Time frame: BL to Day 168. Least squares mean (Standard Error). Unit: meters per second (m/sec)

Measure	Placebo QD n = 85	VI 25 µg QD n = 117	FF/VI 100/25 µg QD n = 103
Value	-1.97 (0.279)	-1.95 (0.241)	-1.75 (0.256)

Placebo QD vs VI 25 µg QD: Least Squares Mean Difference: 0.01 (95% CI -0.71 to 0.74), p = 0.969, Mixed Models Analysis
Placebo QD vs FF/VI 100/25 µg QD: Least Squares Mean Difference: 0.22 (95% CI -0.53 to 0.96), p = 0.568, Mixed Models Analysis
VI 25 µg QD vs FF/VI 100/25 µg QD: Least Squares Mean Difference: 0.20 (95% CI -0.49 to 0.89), p = 0.566, Mixed Models Analysis

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment serious adverse events (SAE) and non-serious AEs were collected from the start of the double-blind (DB) treatment period (Visit 2) through the follow-up contact (7 days after Visit 6 [Week 25]).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo QD	5 of 145 (3.4%)	24 of 145 (16.6%)	Not reported
VI 25 µg QD	12 of 158 (7.6%)	27 of 158 (17.1%)	Not reported
FF/VI 100/25 µg QD	9 of 141 (6.4%)	34 of 141 (24.1%)	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.
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.

Related trials for Pulmonary Disease, Chronic Obstructive

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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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

72 sites in 6 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 and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 72 sites in 6 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 3 inclusion and 26 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 72 sites in United States, Germany, South Korea, Thailand, Philippines 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. 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 10 Jul 2015). 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 (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168) (time frame: BL to Day 168). 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 NCT01336608.

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.