Last updated: 11/04/2018 11:56:48
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.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Rate of moderate/severe exacerbations over a 52 week treatment period.
Timeframe: N/A
Secondary outcomes:
The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.
Timeframe: N/A
Interventions:
Drug: Salmeterol
Drug: Fluticasone Propionate/Salmeterol Combination Product
Enrollment:
740
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. (2008). Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med 102 (8); 1099-1108.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2004 to November 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Diagnosis of COPD (chronic obstructive pulmonary disease).
- Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- Current diagnosis of asthma.
- Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99202
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Study Complete
Location
GSK Investigational Site
Abingdon, Virginia, United States, 24210
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
Status
Study Complete
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Study Complete
Location
GSK Investigational Site
Cumberland, Rhode Island, United States, 02864
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
North Miami Beach, Florida, United States, 33179
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80204
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80113
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825-5480
Status
Study Complete
Location
GSK Investigational Site
Champaign, Illinois, United States, 61821
Status
Study Complete
Location
GSK Investigational Site
Statesville, North Carolina, United States, 28625
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32205
Status
Study Complete
Location
GSK Investigational Site
Saint Leonard, Québec, Canada, H1S 3A9
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61602
Status
Study Complete
Location
GSK Investigational Site
Sepulveda, California, United States, 91343
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63122
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Corona, California, United States, 92879
Status
Study Complete
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Larchmont, New York, United States, 10538
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Study Complete
Location
GSK Investigational Site
Lewistown, New York, United States, 14092
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Study Complete
Location
GSK Investigational Site
Gig Harbor, Washington, United States, 98335
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47710
Status
Study Complete
Location
GSK Investigational Site
Palmdale, California, United States, 93551
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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