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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    El Paso, Texas, United States, 79902
    Status
    Study Complete
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    West Allis, Wisconsin, United States, 53227
    Status
    Study Complete
    Contact us
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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.

    Additional information about the trial

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