- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144911
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.
October 26, 2016 updated by: GlaxoSmithKline
A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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 the 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® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
Enrollment (Actual)
740
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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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R2K 3S8
- GSK Investigational Site
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Ontario
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Grimsby, Ontario, Canada, L3M 1P3
- GSK Investigational Site
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Toronto, Ontario, Canada, M5G 1N8
- GSK Investigational Site
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Quebec
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Cowansville, Quebec, Canada, J2K 2X9
- GSK Investigational Site
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La Malbaie, Quebec, Canada, G5A 1W7
- GSK Investigational Site
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Montreal, Quebec, Canada, H3T 1Y6
- GSK Investigational Site
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Saint Leonard, Quebec, Canada, H1S 3A9
- GSK Investigational Site
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Sainte Jerome, Quebec, Canada, J7Z 5T3
- GSK Investigational Site
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Sainte-Foy, Quebec, Canada, G1V 4G5
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 4J6
- GSK Investigational Site
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Sorel, Quebec, Canada, J3P 1N5
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35209
- GSK Investigational Site
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Birmingham, Alabama, United States, 35294-0012
- GSK Investigational Site
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Jasper, Alabama, United States, 35501
- 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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Scottsdale, Arizona, United States, 85258
- GSK Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- GSK Investigational Site
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California
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Corona, California, United States, 92879
- GSK Investigational Site
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Los Angeles, California, United States, 90095-1752
- GSK Investigational Site
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Palmdale, California, United States, 93551
- GSK Investigational Site
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Paramount, California, United States, 90723
- GSK Investigational Site
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Rancho Mirage, California, United States, 92270
- GSK Investigational Site
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Riverside, California, United States, 92506
- GSK Investigational Site
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Sacramento, California, United States, 95825-5480
- GSK Investigational Site
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San Diego, California, United States, 92120
- GSK Investigational Site
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Sepulveda, California, United States, 91343
- GSK Investigational Site
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Stockton, California, United States, 95207
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80907
- GSK Investigational Site
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Denver, Colorado, United States, 80206
- GSK Investigational Site
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Denver, Colorado, United States, 80204
- GSK Investigational Site
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Englewood, Colorado, United States, 80113
- GSK Investigational Site
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Wheat Ridge, Colorado, United States, 80033
- GSK Investigational Site
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Florida
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Deland, Florida, United States, 32720
- GSK Investigational Site
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Jacksonville, Florida, United States, 32205
- GSK Investigational Site
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Largo, Florida, United States, 33770
- GSK Investigational Site
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North Miami Beach, Florida, United States, 33179
- GSK Investigational Site
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Pensacola, Florida, United States, 32504
- GSK Investigational Site
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Tampa, Florida, United States, 33613
- GSK Investigational Site
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Idaho
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Coeur D'Alene, Idaho, United States, 83814
- GSK Investigational Site
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Illinois
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Champaign, Illinois, United States, 61821
- GSK Investigational Site
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Chicago, Illinois, United States, 60612
- GSK Investigational Site
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Peoria, Illinois, United States, 61602
- GSK Investigational Site
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Indiana
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Evansville, Indiana, United States, 47710
- 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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Des Moines, Iowa, United States, 50309
- GSK Investigational Site
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Louisiana
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Lafayette, Louisiana, United States, 70503
- GSK Investigational Site
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Slidell, Louisiana, United States, 70458
- GSK Investigational Site
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Maine
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Auburn, Maine, United States, 04210
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02118
- GSK Investigational Site
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Worcester, Massachusetts, United States, 01608
- GSK Investigational Site
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Michigan
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Kalamazoo, Michigan, United States, 49009
- GSK Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- GSK Investigational Site
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Rochester, Minnesota, United States, 55905
- GSK Investigational Site
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Missouri
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Kansas City, Missouri, United States, 64108
- 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, 63122
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68134
- GSK Investigational Site
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Omaha, Nebraska, United States, 68105
- GSK Investigational Site
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New Jersey
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Cherry Hill, New Jersey, United States, 08003
- GSK Investigational Site
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Summit, New Jersey, United States, 07091
- GSK Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- GSK Investigational Site
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New York
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Larchmont, New York, United States, 10538
- GSK Investigational Site
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Lewistown, New York, United States, 14092
- GSK Investigational Site
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North Carolina
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Elizabeth City, North Carolina, United States, 27909
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
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Statesville, North Carolina, United States, 28625
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45231
- GSK Investigational Site
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Cincinnati, Ohio, United States, 45219
- GSK Investigational Site
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Cleveland, Ohio, United States, 44109
- GSK Investigational Site
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Columbus, Ohio, United States, 43215
- GSK Investigational Site
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Toledo, Ohio, United States, 43614-5809
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74135
- GSK Investigational Site
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Oregon
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Eugene, Oregon, United States, 97401
- GSK Investigational Site
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Medford, Oregon, United States, 97504
- GSK Investigational Site
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Portland, Oregon, United States, 97213
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- GSK Investigational Site
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Pittsburgh, Pennsylvania, United States, 15243
- GSK Investigational Site
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Rhode Island
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Cumberland, Rhode Island, United States, 02864
- GSK Investigational Site
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Providence, Rhode Island, United States, 02906
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29406-7108
- 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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Johnson City, Tennessee, United States, 37601
- GSK Investigational Site
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Texas
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Corsicana, Texas, United States, 75110
- GSK Investigational Site
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Fort Worth, Texas, United States, 76104
- GSK Investigational Site
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Houston, Texas, United States, 77030
- GSK Investigational Site
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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Virginia
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Abingdon, Virginia, United States, 24210
- GSK Investigational Site
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Charlottesville, Virginia, United States, 22908
- GSK Investigational Site
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Newport News, Virginia, United States, 23606
- GSK Investigational Site
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Washington
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Gig Harbor, Washington, United States, 98335
- GSK Investigational Site
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Spokane, Washington, United States, 99202
- 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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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 (chronic obstructive pulmonary disease).
- Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- History of a 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:
- Current 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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Other Names:
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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.
General Publications
- Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9.
- 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 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
October 1, 2004
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
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
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Salmeterol Xinafoate
Other Study ID Numbers
- SCO40043
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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Study Protocol
Information identifier: SCO40043Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: SCO40043Information 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: SCO40043Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: SCO40043Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: SCO40043Information 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: SCO40043Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: SCO40043Information 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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