- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115492
Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
January 19, 2017 updated by: GlaxoSmithKline
A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations.
This study will last up to 56 weeks, and subjects will visit the clinic 10 times.
Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards.
All study related medicines and medical examinations will be provided at no cost.
The two drugs used in this study have been approved by FDA for use in patients with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
Enrollment (Actual)
797
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3J5
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 3S8
- GSK Investigational Site
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New Brunswick
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Saint John, New Brunswick, Canada, E2M 3W5
- GSK Investigational Site
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
- GSK Investigational Site
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Holyrood, Newfoundland and Labrador, Canada, A0A 2R0
- GSK Investigational Site
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Ontario
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Grimsby, Ontario, Canada, L3M 1P3
- GSK Investigational Site
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London, Ontario, Canada, N6C 4Y7
- GSK Investigational Site
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Thunder Bay, Ontario, Canada, P7A 4V7
- GSK Investigational Site
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Quebec
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Bonaventure, Quebec, Canada, G0C 1E0
- GSK Investigational Site
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Chandler, Quebec, Canada, G0C 1K0
- GSK Investigational Site
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Charlesbourg, Quebec, Canada, G1G 4A2
- GSK Investigational Site
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Gatineau, Quebec, Canada, J8Y 6S8
- GSK Investigational Site
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Saint Leonard, Quebec, Canada, H1S 3A9
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 1Z1
- GSK Investigational Site
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Trois Rivieres, Quebec, Canada, G8T 7A1
- GSK Investigational Site
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Alabama
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Jasper, Alabama, United States, 35501
- GSK Investigational Site
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Mobile, Alabama, United States, 36608
- GSK Investigational Site
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Arizona
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Glendale, Arizona, United States, 85306
- GSK Investigational Site
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Phoenix, Arizona, United States, 85013
- GSK Investigational Site
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California
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Berkeley, California, United States, 94705
- GSK Investigational Site
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Fullerton, California, United States, 92835
- GSK Investigational Site
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Riverside, California, United States, 92506
- GSK Investigational Site
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Sacramento, California, United States, 95825
- GSK Investigational Site
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San Diego, California, United States, 92123
- GSK Investigational Site
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Vista, California, United States, 92084
- GSK Investigational Site
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Colorado
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Fort Collins, Colorado, United States, 80528
- GSK Investigational Site
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Connecticut
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Stamford, Connecticut, United States, 06902
- GSK Investigational Site
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Florida
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Atlantis, Florida, United States, 33462
- GSK Investigational Site
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Clear Water, Florida, United States, 33756
- GSK Investigational Site
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Deland, Florida, United States, 32720
- GSK Investigational Site
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Fort Lauderdale, Florida, United States, 33316
- GSK Investigational Site
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Pensacola, Florida, United States, 32504
- GSK Investigational Site
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Sarasota, Florida, United States, 34239
- GSK Investigational Site
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Tamarac, Florida, United States, 33321
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30342
- GSK Investigational Site
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Woodstock, Georgia, United States, 30189
- GSK Investigational Site
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Illinois
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Springfield, Illinois, United States, 62702
- GSK Investigational Site
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Indiana
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Elkhart, Indiana, United States, 46154
- GSK Investigational Site
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Evansville, Indiana, United States, 47714
- GSK Investigational Site
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Evansville, Indiana, United States, 47710
- GSK Investigational Site
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Indianapolis, Indiana, United States, 46208
- GSK Investigational Site
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South Bend, Indiana, United States, 46617
- GSK Investigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- GSK Investigational Site
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Kansas
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Olathe, Kansas, United States, 66061
- GSK Investigational Site
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Kentucky
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Madisonville, Kentucky, United States, 42431
- GSK Investigational Site
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Louisiana
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Lafayette, Louisiana, United States, 70503
- GSK Investigational Site
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New Orleans, Louisiana, United States, 70112
- GSK Investigational Site
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Shreveport, Louisiana, United States, 71103
- GSK Investigational Site
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Sunset, Louisiana, United States, 70584
- GSK Investigational Site
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Maine
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Auburn, Maine, United States, 04210
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21201
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02135
- GSK Investigational Site
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Michigan
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St. Joseph, Michigan, United States, 49085
- GSK Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- GSK Investigational Site
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Missouri
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Chesterfield, Missouri, United States, 63017
- GSK Investigational Site
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Jefferson City, Missouri, United States, 65101
- GSK Investigational Site
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St. Charles, Missouri, United States, 63301
- GSK Investigational Site
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St. Louis, Missouri, United States, 63110
- GSK Investigational Site
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Montana
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Billings, Montana, United States, 59102
- GSK Investigational Site
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Butte, Montana, United States, 59701
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68131
- GSK Investigational Site
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Omaha, Nebraska, United States, 68124
- GSK Investigational Site
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New Jersey
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Absecon, New Jersey, United States, 08201
- GSK Investigational Site
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New York
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Albany, New York, United States, 12205
- GSK Investigational Site
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Bayshore, New York, United States, 11706
- GSK Investigational Site
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Ithaca, New York, United States, 14850
- GSK Investigational Site
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Larchmont, New York, United States, 10538
- GSK Investigational Site
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New York, New York, United States, 10016
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- GSK Investigational Site
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Charlotte, North Carolina, United States, 28207
- GSK Investigational Site
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Elizabeth City, North Carolina, United States, 27909
- GSK Investigational Site
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High Point, North Carolina, United States, 27262
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27612
- GSK Investigational Site
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Winston-Salem, North Carolina, United States, 27157
- GSK Investigational Site
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Ohio
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Canton, Ohio, United States, 44718
- GSK Investigational Site
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Chardon, Ohio, United States, 44024
- GSK Investigational Site
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Mogadore, Ohio, United States, 44260
- GSK Investigational Site
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Oregon
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Lake Oswego, Oregon, United States, 97035
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, United States, 16508
- GSK Investigational Site
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Hershey, Pennsylvania, United States, 17033
- GSK Investigational Site
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McKeesport, Pennsylvania, United States, 15132
- GSK Investigational Site
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Pittsburgh, Pennsylvania, United States, 15243
- GSK Investigational Site
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Pittsburgh, Pennsylvania, United States, 15025
- GSK Investigational Site
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- GSK Investigational Site
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Providence, Rhode Island, United States, 2909
- GSK Investigational Site
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South Carolina
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Gaffney, South Carolina, United States, 29340
- GSK Investigational Site
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Greer, South Carolina, United States, 29651
- GSK Investigational Site
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Simpsonville, South Carolina, United States, 29681
- GSK Investigational Site
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Spartanburg, South Carolina, United States, 29303
- GSK Investigational Site
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Tennessee
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Bristol, Tennessee, United States, 37620
- GSK Investigational Site
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Chattanooga, Tennessee, United States, 37403
- GSK Investigational Site
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Johnson City, Tennessee, United States, 37601
- GSK Investigational Site
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Kingsport, Tennessee, United States, 37660
- GSK Investigational Site
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Texas
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Dallas, Texas, United States, 75390-9016
- GSK Investigational Site
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Houston, Texas, United States, 77074
- GSK Investigational Site
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New Braunfels, Texas, United States, 78130
- GSK Investigational Site
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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San Antonio, Texas, United States, 78217
- GSK Investigational Site
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San Marcos, Texas, United States, 78666
- GSK Investigational Site
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Virginia
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Abingdon, Virginia, United States, 24210
- GSK Investigational Site
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Lynchburg, Virginia, United States, 24501
- GSK Investigational Site
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Newport News, Virginia, United States, 23606
- GSK Investigational Site
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Richmond, Virginia, United States, 23225
- GSK Investigational Site
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Washington
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Bellingham, Washington, United States, 98226
- GSK Investigational Site
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Gig Harbor, Washington, United States, 98335
- GSK Investigational Site
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Kirkland, Washington, United States, 98034
- GSK Investigational Site
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Spokane, Washington, United States, 99204
- GSK Investigational Site
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West Virginia
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Morgantown, West Virginia, United States, 26505
- GSK Investigational Site
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- GSK Investigational Site
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Milwaukee, Wisconsin, United States, 53209
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Diagnosis of COPD.
- 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:
- Diagnosis of asthma.
- 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.
- Other inclusion and exclusion criteria will be evaluated at the first study visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of moderate/severe exacerbations over a 52 week treatment period
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Secondary Outcome Measures
Outcome Measure |
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The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
June 22, 2005
First Submitted That Met QC Criteria
June 22, 2005
First Posted (Estimate)
June 23, 2005
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 19, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Fluticasone
- Xhance
- Salmeterol Xinafoate
- Fluticasone-Salmeterol Drug Combination
Other Study ID Numbers
- SCO100250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Dataset Specification
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: SCO100250Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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