Last updated: 11/04/2018 11:58:21

Study Of Asthma In Patients Of African Descent

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GSK study ID
SFA103153
See study documents
Clinicaltrials.gov ID
NCT00102765
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: A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone
Trial description: This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
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 powder
  • Drug: fluticasone propionate powder
    • Enrollment:
    479
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bailey W, Castro M, Matz J, et al. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin 2008;24(6):1669–82.
    Wayne Anderson, Beena Koshy, Lingkang Huang, Mike Mosteller, Sandy Stinnett, Lynn Condreay, Hector Ortega. A Genetic Analysis of Asthma Exacerbations .Ann Allergy Asthma Immunol.2013;110(6):416–422
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to April 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 65 years
    Accepts healthy volunteers
    No
    • History of asthma for at least 6 months.
    • Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).
    • History of life-threatening asthma.
    • Hospitalized for asthma within 3 months prior to the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • History of asthma for at least 6 months.
    • Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).
    Exclusion criteria:
    • History of life-threatening asthma.
    • Hospitalized for asthma within 3 months prior to the study.
    • Current respiratory tract infection.
    • Will not be able to attend clinic visits for the entire length of the study.
    • Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55455
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    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
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flossmoor, Illinois, United States, 60422
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02114
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Picayune, Mississippi, United States, 39466
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10032
    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
    Little Rock, Arkansas, United States, 72204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muscle Shoals, Alabama, United States, 35662
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104-6160
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78750
    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
    West Sayville, New York, United States, 11796
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37909
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294-0012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Georgia, United States, 31904
    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
    Los Angeles, California, United States, 90048
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Ypsilanti, Michigan, United States, 48197
    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
    Verona, New Jersey, United States, 07044
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21236
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette, Louisiana, United States, 70503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Francisco, California, United States, 94102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29406-7108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20060
    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
    High Point, North Carolina, United States, 27262
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23507
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31406
    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
    Hartford, Connecticut, United States, 06105
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    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
    Mobile, Alabama, United States, 36608
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37421
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37208
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Martinez, Georgia, United States, 30907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, Virginia, United States, 23601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jenkintown, Pennsylvania, United States, 19406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37920
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29607
    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
    Montgomery, Alabama, United States, 36106
    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
    Jackson, Mississippi, United States, 39202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palmdale, California, United States, 93551
    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
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20010
    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
    Riverside, California, United States, 92506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brooklyn, New York, United States, 11215
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sylvania, Ohio, United States, 43560
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Elizabeth City, North Carolina, United States, 27909
    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
    2007-12-04

    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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