Pulmonary Disease, Chronic ObstructivePhase 4NCT00857766

A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing ADVAIR DISKUS™ 250/50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 24 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: ADVAIR DISKUS™ 250/50mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: 24 sitesUnited States
Study dates: Mar 2009to Mar 2010
Phase: Phase 4
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
Males or females greater then or equal to 50 years of age.
A post-albuterol FEV1/FVC ratio of < or equal to 0.70
A post-albuterol FEV1 < 80% of predicted normal.
Patients can be current or fomer smoker and must have a cigarette smoking history of > greater then or equal to 10 pack-years .

Who cannot join

A current diagnosis of asthma
A body mass index (BMI) of > or equal to 35kg/m2
A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Downington, Pennsylvania, 19335
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
San Diego, California, 92103-8415
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Union, South Carolina, 29379

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Read the detailed description

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC) BID on arterial stiffness in COPD subjects. Following a 1 to 14 day run-in period, approximately 250 subjects will be randomly assigned to double-blind treatment for 12 weeks. After the 12 week treatment period, subjects in both treatment arms will receive open label Tiotropium bromide Handihaler18mcg (Tio)QD for 4 weeks in addition to their continued study drug (either FSC250/50 or placebo). The primary measure of efficacy is Pulse Wave Velocity (PWV) at Endpoint. Secondary efficacy measures include Augmentation Index (AIx), Biomarkers of cardiovascular disease, measures of lung function. (e.g. FEV1). Safety will be assessed through the collection of adverse events and COPD exacerbations. Exploratory endpoints include the effect of Tiotropium on PWV and AIx when added to placebo or FSC. Treatment groups will be stratified based on current smoking status. There will be a total of 6 study visits (screening, randomization, and after 4, 8, 12 and 16 weeks of treatment). A follow-up phone contact for collection of adverse event and pregnancy information (if applicable) will be conducted approximately 14 days following the last study visit.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: ADVAIR DISKUS™ 250/50mcg, Placebo
Keywords: Chronic Obstructive Pulmonary Disease, arterial stiffness, Computed Tomography, pulse wave velocity, Pulse wave analysis
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.

ADVAIR DISKUS™ 250/50mcgDrug
ADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
PlaceboOther
COPD subjects-Placebo DISKUS

Study groups in NCT00857766
Study group	Role	What they receive
ADVAIR DISKUS	Active comparator	Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER Receives: Drug: ADVAIR DISKUS™ 250/50mcg
Placebo	Placebo comparator	Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER Receives: Other: Placebo

What is being measured

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

Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint
The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.
Measured: Baseline and the 12-Week Endpoint (up to Week 12)

Secondary outcomes (2)

Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint
AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.
Measured: Baseline and the 12-Week Endpoint (up to Week 12)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint
FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.
Measured: Baseline and the 12-Week Endpoint (up to Week 12)

Timeline

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

Mar 2009Mar 2010

First posted9 Mar 2009 (estimated)
Study startMar 2009
Primary completionMar 2010
Study completionMar 2010

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 (2)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857766
Sponsor's protocol ID: 112355
Status last verified: Dec 2016
First submitted: 5 Mar 2009
Last updated: 30 Jan 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.

Publications

Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30. doi: 10.1016/j.rmed.2011.05.016. Epub 2011 Jun 22.
PubMed 21696934
Bhatt SP, Cole AG, Wells JM, Nath H, Watts JR, Cockcroft JR, Dransfield MT. Determinants of arterial stiffness in COPD. BMC Pulm Med. 2014 Jan 4;14:1. doi: 10.1186/1471-2466-14-1.
PubMed 24387157

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 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00857766
Acronym / sponsor ID: 112355
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease, arterial stiffness, Computed Tomography, pulse wave velocity, Pulse wave analysis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 9 Mar 2009 (estimated)
Results: Posted 23 Dec 2010

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
ADVAIR DISKUS	Active comparator	Drug: ADVAIR DISKUS™ 250/50mcgSubjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER
Placebo	Placebo comparator	Other: PlaceboSubjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
Males or females greater then or equal to 50 years of age.
A post-albuterol FEV1/FVC ratio of < or equal to 0.70
A post-albuterol FEV1 < 80% of predicted normal.
Patients can be current or fomer smoker and must have a cigarette smoking history of > greater then or equal to 10 pack-years .

Key exclusion criteria (3 listed)

A current diagnosis of asthma
A body mass index (BMI) of > or equal to 35kg/m2
A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).

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
ADVAIR DISKUS™ 250/50mcgADVAIR DISKUS™ 250/50mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS™ 250/50mcg is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.	Drug	ADVAIR DISKUS
PlaceboCOPD subjects-Placebo DISKUS	Other	Placebo

Primary outcome

Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint
Time frame: Baseline and the 12-Week Endpoint (up to Week 12)
The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.

2 secondary outcomes

Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint
Time frame: Baseline and the 12-Week Endpoint (up to Week 12)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint
Time frame: Baseline and the 12-Week Endpoint (up to Week 12)

Results and safety

Results posted to the registry on 23 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FSC DISKUS 250/50 mcg	123	92
Matching Placebo	126	96

Primary outcome: Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint

Time frame: Baseline and the 12-Week Endpoint (up to Week 12). Mean (Standard Error). Unit: meters per second (m/s)

Measure	FSC DISKUS 250/50 mcg n = 118	Matching Placebo n = 122
Baseline, n=118, 122	10.06 (0.26)	9.87 (0.25)
12-Week Endpoint, n=113, 110	9.83 (0.24)	9.95 (0.26)
Change from Baseline	-0.24 (0.194)	0.13 (0.157)

FSC DISKUS 250/50 mcg vs Matching Placebo: Least squares (LS) mean difference: -0.42 (95% CI -0.88 to 0.03), p = 0.065, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized to study drug. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 week observation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FSC DISKUS 250/50 mcg	8 of 123 (6.5%)	9 of 123 (7.3%)	Not reported
Matching Placebo	8 of 126 (6.3%)	7 of 126 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21696934Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30. doi: 10.1016/j.rmed.2011.05.016. Epub 2011 Jun 22.
Derived from this study: PubMed 24387157Bhatt SP, Cole AG, Wells JM, Nath H, Watts JR, Cockcroft JR, Dransfield MT. Determinants of arterial stiffness in COPD. BMC Pulm Med. 2014 Jan 4;14:1. doi: 10.1186/1471-2466-14-1.
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

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ADVAIR DISKUS™ 250/50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 24 sites in United States.

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 3 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 30 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 24 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 23 Dec 2010). 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 Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint (time frame: Baseline and the 12-Week Endpoint (up to Week 12)). 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 NCT00857766, which also lists 2 linked publications.

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 30 Jan 2017.