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
    • Inclusion criteria:
    • History of asthma for at least 6 months.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    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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    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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