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

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ClinicalTrials.gov Identifier: NCT00857766

Recruitment Status : Completed

First Posted : March 9, 2009

Results First Posted : December 23, 2010

Last Update Posted : January 30, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: ADVAIR DISKUS™ 250/50mcg Other: Placebo	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	249 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Study Start Date :	March 2009
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Salmeterol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ADVAIR DISKUS Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER	Drug: ADVAIR DISKUS™ 250/50mcg 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.
Placebo Comparator: Placebo Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER	Other: Placebo COPD subjects-Placebo DISKUS

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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) ]
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.
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) ]
FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 .

Exclusion Criteria:

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).

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857766

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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