A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease; Chronic Bronchitis; Chronic Obstructive Pulmonary Disease (COPD); CV Risk; Emphysema; Smoking
Intervention: ADVAIR DISKUS™ 250/50mcg (Drug); Placebo (Other)
Phase: N/A
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718
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.
Clinical Details
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 design: Case-Only, Prospective
Primary outcome: The primary outcome measure is Pulse Wave Velocity.
Secondary outcome: The secondary outcome measures are Augmentation Index (AIx) and Forced Expiratory Volume in 1 second (FEV1)
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718
GSK Investigational Site, Birmingham, Alabama 35294, United States; Recruiting
GSK Investigational Site, Jasper, Alabama 35501, United States; Recruiting
GSK Investigational Site, Florence, Alabama 35630, United States; Not yet recruiting
GSK Investigational Site, Mobile, Alabama 36608, United States; Recruiting
GSK Investigational Site, Phoenix, Arizona 85006, United States; Recruiting
GSK Investigational Site, Torrance, California 90505, United States; Recruiting
GSK Investigational Site, San Diego, California 92103-8415, United States; Recruiting
GSK Investigational Site, Hartford, Connecticut 06105, United States; Recruiting
GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States; Recruiting
GSK Investigational Site, Sunset, Louisiana 70584, United States; Recruiting
GSK Investigational Site, Minneapolis, Minnesota 55407, United States; Recruiting
GSK Investigational Site, Chesterfield, Missouri 63017, United States; Recruiting
GSK Investigational Site, St. Louis, Missouri 63141, United States; Recruiting
GSK Investigational Site, St. Charles, Missouri 63301, United States; Recruiting
GSK Investigational Site, Charlotte, North Carolina 28207, United States; Recruiting
GSK Investigational Site, Downington, Pennsylvania 19335, United States; Recruiting
GSK Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting
GSK Investigational Site, Union, South Carolina 29379, United States; Recruiting
GSK Investigational Site, Charleston, South Carolina 29406-7108, United States; Recruiting
GSK Investigational Site, Greenville, South Carolina 29615, United States; Recruiting
GSK Investigational Site, Gaffney, South Carolina 29340, United States; Recruiting
GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Recruiting
GSK Investigational Site, Johnson City, Tennessee 37601, United States; Recruiting
GSK Investigational Site, Spokane, Washington 99204, United States; Recruiting
GSK Investigational Site, Morgantown, West Virginia 26505, United States; Recruiting
Additional Information
Starting date: March 2009
Ending date: September 2010
Last updated: August 13, 2009
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