Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A stratified, randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of fluticasone propionate/salmeterol DISKUS combination product 100/50mcg once daily versus fluticasone propionate DISKUS 100mcg once daily and placebo in symptomatic pediatric subjects (4-11 years) with asthma
Trial description: To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline at endpoint in daily PM PEF
Timeframe: 12 weeks
Secondary outcomes:
Various pulmonary function endpoints
Timeframe: 12 weeks
Interventions:
Drug: FP 100mcg
Drug: FSC 100/50mcg
Drug: Placebo
Enrollment:
908
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2001 to January 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- Out-patients
- Asthma diagnosis
- Life-threatening asthma
- Specified asthma medications
Inclusion and exclusion criteria
Inclusion criteria:
- Out-patients
- Asthma diagnosis
- Reversibility
- Short-acting beta-agonist or asthma controlled medication use
Exclusion criteria:
- Life-threatening asthma
- Specified asthma medications
- Chickenpox
- Drug allergy
- Respiratory infections
- Tobacco use
- Clinical laboratory abnormalities
- Ophthalmologic conditions
- Investigation medications
- Affiliation with investigator site
Trial location(s)
Location
GSK Investigational Site
Edmonds, Washington, United States, 98026
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40222
Status
Recruiting
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Recruiting
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Recruiting
Location
GSK Investigational Site
San Jose, California, United States, 95117
Status
Recruiting
Location
GSK Investigational Site
Panorama City, California, United States, 91402
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55416
Status
Recruiting
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78749
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30309-7520
Status
Recruiting
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Recruiting
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19135
Status
Recruiting
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Recruiting
Location
GSK Investigational Site
Columbia, Missouri, United States, 65212
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Recruiting
Location
GSK Investigational Site
Taunton, Massachusetts, United States, 02780
Status
Recruiting
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Recruiting
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Recruiting
Location
GSK Investigational Site
Barnesville, Georgia, United States, 30204
Status
Recruiting
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Recruiting
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
Status
Recruiting
Location
GSK Investigational Site
Rockville Center, New York, United States, 11570
Status
Recruiting
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Recruiting
Location
GSK Investigational Site
Charleston, West Virginia, United States, 25301
Status
Recruiting
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15202
Status
Recruiting
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Recruiting
Location
GSK Investigational Site
Durham, North Carolina, United States, 27704
Status
Recruiting
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Recruiting
Location
GSK Investigational Site
San Francisco, California, United States, 94102
Status
Recruiting
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Recruiting
Location
GSK Investigational Site
Palmdale, California, United States, 93551
Status
Recruiting
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Recruiting
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Recruiting
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Recruiting
Location
GSK Investigational Site
Blue Belle, Pennsylvania, United States, 19422
Status
Recruiting
Location
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Recruiting
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Recruiting
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Recruiting
Location
GSK Investigational Site
San Antonio, Texas, United States, 78207
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
Status
Recruiting
Location
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60195
Status
Recruiting
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Recruiting
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Recruiting
Location
GSK Investigational Site
Glenview, Illinois, United States, 60025
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Recruiting
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63139
Status
Study Complete
Location
GSK Investigational Site
Sherman Oaks, California, United States, 91403
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
Status
Recruiting
Location
GSK Investigational Site
Martinez, Georgia, United States, 30907
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Recruiting
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Newton, Massachusetts, United States, 02462
Status
Recruiting
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Status
Recruiting
Location
GSK Investigational Site
New Hyde Park, New York, United States, 11042
Status
Recruiting
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Recruiting
Location
GSK Investigational Site
Galveston, Texas, United States, 77555-0188
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Recruiting
Location
GSK Investigational Site
Lewisburg, Pennsylvania, United States, 17837
Status
Recruiting
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Recruiting
Location
GSK Investigational Site
San Antonio, Texas, United States, 78233
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Recruiting
Location
GSK Investigational Site
Lawrence, Kansas, United States, 66047
Status
Study Complete
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
Status
Recruiting
Location
GSK Investigational Site
East Orange, New Jersey, United States, 7017
Status
Recruiting
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Recruiting
Location
GSK Investigational Site
Harrisburg, Pennsylvania, United States, 17110
Status
Study Complete
Location
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
Status
Recruiting
Location
GSK Investigational Site
Crescent City, California, United States, 95531
Status
Recruiting
Location
GSK Investigational Site
West Quincy, Massachusetts, United States, 02169
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Recruiting
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
Status
Recruiting
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Recruiting
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Recruiting
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16601
Status
Recruiting
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Recruiting
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Recruiting
Location
GSK Investigational Site
New Braunfels, Texas, United States, 78130
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37917
Status
Recruiting
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Recruiting
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Recruiting
Location
GSK Investigational Site
Beverly Hills, California, United States, 90212
Status
Recruiting
Location
GSK Investigational Site
Buffalo, New York, United States, 14222
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
2004-03-01
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.
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