A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD) - NCT00857766-28207 (Clinical Trial 276701)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy276701.aspx
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| City: |
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Charlotte |
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State:
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NC |
| Zip Code: |
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28207 |
| Conditions: |
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Cardiovascular Disease - Chronic Bronchitis - Chronic Obstructive Pulmonary Disease (COPD) - CV Risk - Emphysema - Smoking |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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). |
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| Study is available at: |
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GSK Investigational Site
Charlotte, NC 28207
United States
Primary Contact:
US GSK Clinical Trials Call Center
Phone: 877-379-3718 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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