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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00857766 |
Purpose
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 | Intervention |
|---|---|
|
Cardiovascular Disease Chronic Bronchitis Chronic Obstructive Pulmonary Disease (COPD) CV Risk Emphysema Smoking |
Drug: ADVAIR DISKUS™ 250/50mcg Other: Placebo |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| 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) |
DNA derived from blood will be stored
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Placebo
Subjects will receive placebo ADVAIR DISKUS. At 4 months subjects will receive open label SPIRIVA HANDIHALER
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Other: Placebo
COPD subjects-Placebo DISKUS
|
|
ADVAIR DISKUS
Subjects receive blinded Fluticasone Propionate/Salmeterol. At 4 months subjects will receive open label SPIRIVA HANDIHALER
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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.
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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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects with COPD who have at least a 10 pack year smoking history and obstruction as defined by pulmonary function test.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 25 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 112355 |
| Study First Received: | March 5, 2009 |
| Last Updated: | August 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00857766 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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pulse wave velocity arterial stiffness Chronic Obstructive Pulmonary Disease Computed Tomography Pulse wave analysis |
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Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Albuterol Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Pulmonary Emphysema Lung Diseases, Obstructive Pathologic Processes Tocolytic Agents Respiratory Tract Infections |
Respiratory Tract Diseases Therapeutic Uses Fluticasone Cardiovascular Diseases Bronchitis Dermatologic Agents Emphysema Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Bronchitis, Chronic Autonomic Agents |