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.
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)
1 other identifier
interventional
740
2 countries
97
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2004
Typical duration for phase_4
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 28, 2016
October 1, 2016
2.2 years
September 1, 2005
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of moderate/severe exacerbations over a 52 week treatment period.
Secondary Outcomes (1)
The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (97)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35294-0012, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Scottsdale, Arizona, 85258, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Corona, California, 92879, United States
GSK Investigational Site
Los Angeles, California, 90095-1752, United States
GSK Investigational Site
Palmdale, California, 93551, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Rancho Mirage, California, 92270, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95825-5480, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Sepulveda, California, 91343, United States
GSK Investigational Site
Stockton, California, 95207, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Denver, Colorado, 80204, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Englewood, Colorado, 80113, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Largo, Florida, 33770, United States
GSK Investigational Site
North Miami Beach, Florida, 33179, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Champaign, Illinois, 61821, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Evansville, Indiana, 47710, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Des Moines, Iowa, 50309, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
Slidell, Louisiana, 70458, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Worcester, Massachusetts, 01608, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Rochester, Minnesota, 55905, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
St Louis, Missouri, 63122, United States
GSK Investigational Site
Omaha, Nebraska, 68105, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08003, United States
GSK Investigational Site
Summit, New Jersey, 07091, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Larchmont, New York, 10538, United States
GSK Investigational Site
Lewistown, New York, 14092, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Tulsa, Oklahoma, 74135, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Cumberland, Rhode Island, 02864, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Gig Harbor, Washington, 98335, United States
GSK Investigational Site
Spokane, Washington, 99202, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Calgary, Alberta, T2N 4N1, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8, Canada
GSK Investigational Site
Grimsby, Ontario, L3M 1P3, Canada
GSK Investigational Site
Toronto, Ontario, M5G 1N8, Canada
GSK Investigational Site
Cowansville, Quebec, J2K 2X9, Canada
GSK Investigational Site
La Malbaie, Quebec, G5A 1W7, Canada
GSK Investigational Site
Montreal, Quebec, H3T 1Y6, Canada
GSK Investigational Site
Saint-Léonard, Quebec, H1S 3A9, Canada
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6, Canada
GSK Investigational Site
Sorel-Tracy, Quebec, J3P 1N5, Canada
Related Publications (2)
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.
PMID: 18614347BACKGROUNDDisantostefano 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.
PMID: 23613569DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
October 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.