Last updated: 11/04/2018 11:57:28

Study Of Asthma And Genetics In Patients To Be Treated With fluticasone propionate/salmeterol Or salmeterol xinafoate

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GSK study ID
SFA100062
See study documents
Clinicaltrials.gov ID
NCT00102882
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in subjects with ARG/ARG genotype 12 years of Age and Older with Presistent Asthma on Short-Acting Beta2-Agonists Alone
Trial description: This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: fluticasone propionate/salmeterol
Drug: salmeterol xinafoate
Enrollment:
547
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salbutamol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2004 to January 2007
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
12 years - 0 Not applicable
Accepts healthy volunteers
No
  • Diagnosis of persistent asthma for 3 months.
  • Use of short-acting beta-agonist medication like VENTOLIN.
  • Hospitalization for asthma 6 months before study.
  • Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
Inclusion and exclusion criteria
Inclusion criteria:
  • Diagnosis of persistent asthma for 3 months.
  • Use of short-acting beta-agonist medication like VENTOLIN.
Exclusion criteria:
  • Hospitalization for asthma 6 months before study.
  • Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
  • Current use of inhaled or oral corticosteroids.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
El Paso, Texas, United States, 79902
Status
Study Complete
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Location
GSK Investigational Site
Houston, Texas, United States, 77054
Status
Study Complete
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Location
GSK Investigational Site
Metairie, Louisiana, United States, 70002
Status
Study Complete
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Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
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Location
GSK Investigational Site
Miami, Florida, United States, 33136
Status
Study Complete
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Location
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
Status
Study Complete
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Location
GSK Investigational Site
South Miami, Florida, United States, 33143
Status
Study Complete
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Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
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Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
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Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Bayshore, New York, United States, 11706
Status
Study Complete
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Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
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Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
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Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
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Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
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Location
GSK Investigational Site
Papillion, Nebraska, United States, 68046
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237
Status
Study Complete
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Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
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Location
GSK Investigational Site
Nairobi, Kenya, 00200
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19143
Status
Study Complete
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Location
GSK Investigational Site
Hato Rey, Puerto Rico, Puerto Rico, 00917
Status
Study Complete
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Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
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Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
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Location
GSK Investigational Site
Dallas, Texas, United States, 75246
Status
Study Complete
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Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
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Location
GSK Investigational Site
Overland Park, Kansas, United States, 66210
Status
Study Complete
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Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
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Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
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Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
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Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
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Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
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Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
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Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
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Location
GSK Investigational Site
Sarasota, Florida, United States, 34233
Status
Study Complete
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Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
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Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
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Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
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Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
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Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
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Location
GSK Investigational Site
Lakewood, Colorado, United States, 80401
Status
Study Complete
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Location
GSK Investigational Site
Charleston, South Carolina, United States, 29414
Status
Study Complete
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Location
GSK Investigational Site
El Paso, Texas, United States, 79925
Status
Study Complete
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Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Study Complete
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Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
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Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
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Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
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Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
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Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
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Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Study Complete
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Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
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Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
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Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
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Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
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Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
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Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Study Complete
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Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
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Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
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Location
GSK Investigational Site
Medford, Oregon, United States, 97504
Status
Study Complete
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Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
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Location
GSK Investigational Site
Lima, Lima, Peru, Lima 1
Status
Study Complete
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Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
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Location
GSK Investigational Site
San Isidro, Lima, Peru, Lima 27
Status
Study Complete
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Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53219
Status
Study Complete
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
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Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
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Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
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Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
Status
Study Complete
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
Status
Study Complete
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Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
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Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
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Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Study Complete
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Location
GSK Investigational Site
Newark, New Jersey, United States, 07103-2499
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Tampa, Florida, United States, 33613
Status
Study Complete
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Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
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Location
GSK Investigational Site
Denver, Colorado, United States, 80209
Status
Study Complete
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Location
GSK Investigational Site
Lilburn, Georgia, United States, 30047
Status
Study Complete
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Location
GSK Investigational Site
Miami, Florida, United States, 33176
Status
Study Complete
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Location
GSK Investigational Site
Inglewood, California, United States, 90301
Status
Study Complete
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Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
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Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
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Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
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Location
GSK Investigational Site
Mobile, Alabama, United States, 36608
Status
Study Complete
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Location
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
Status
Study Complete
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Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
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Location
GSK Investigational Site
Kirkland, Washington, United States, 98034
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Atlanta, Georgia, United States, 30310
Status
Study Complete
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Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2007-23-01

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.

Additional information about the trial

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