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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Study complete
    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.

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