Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
NCT ID: NCT00115492
Last Updated: 2017-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
797 participants
INTERVENTIONAL
2004-12-31
2007-06-30
Brief Summary
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ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.
NCT00144911
ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers Are Trademarks of the GSK Group of Companies.
NCT00346749
Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
NCT01110200
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease
NCT00403286
A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50
NCT03562923
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Fluticasone Propionate/Salmeterol Combination Product
Salmeterol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
* History of at least 1 COPD exacerbation in the 12 months prior to screening.
* Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.
Exclusion Criteria
* Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
* Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
* Lung resection surgery within 1 year of screening.
* Abnormal and clinically significant ECG findings at screening.
40 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Jasper, Alabama, United States
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Mobile, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Berkeley, California, United States
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Fullerton, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Vista, California, United States
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Fort Collins, Colorado, United States
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Stamford, Connecticut, United States
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Atlantis, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Pensacola, Florida, United States
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Sarasota, Florida, United States
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Tamarac, Florida, United States
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Atlanta, Georgia, United States
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Woodstock, Georgia, United States
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Springfield, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Olathe, Kansas, United States
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Madisonville, Kentucky, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Sunset, Louisiana, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Saint Joseph, Michigan, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Absecon, New Jersey, United States
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Albany, New York, United States
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Bay Shore, New York, United States
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Ithaca, New York, United States
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Larchmont, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Chardon, Ohio, United States
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Mogadore, Ohio, United States
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Lake Oswego, Oregon, United States
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Erie, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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McKeesport, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Gaffney, South Carolina, United States
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Greer, South Carolina, United States
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Simpsonville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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New Braunfels, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Abingdon, Virginia, United States
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Lynchburg, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Bellingham, Washington, United States
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Gig Harbor, Washington, United States
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Kirkland, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Holyrood, Newfoundland and Labrador, Canada
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Grimsby, Ontario, Canada
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London, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Bonaventure, Quebec, Canada
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Chandler, Quebec, Canada
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Charlesbourg, Quebec, Canada
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Gatineau, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Sherbrooke, Quebec, Canada
GSK Investigational Site
Trois-Rivières, Quebec, Canada
Countries
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References
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Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.
Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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SCO100250
Identifier Type: -
Identifier Source: org_study_id
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