Last updated: 11/04/2018 04:30:10

Study Of Patients With Allergic Rhinitis And Asthma

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GSK study ID
ADA103578
See study documents
Clinicaltrials.gov ID
NCT00296530
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, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Trial description: This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
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: fluticasone propionate
  • Drug: montelukast
    • Enrollment:
    600
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    September 2005 to July 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    No
    • Have asthma for at least 3 months prior to the study.
    • Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
    • Have a history of life-threatening asthma.
    • Been hospitalized for asthma within the 6 months prior to the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Have asthma for at least 3 months prior to the study.
    • Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
    • Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
    • Have a positive allergy skin test.
    Exclusion criteria:
    • Have a history of life-threatening asthma.
    • Been hospitalized for asthma within the 6 months prior to the study.
    • Have certain conditions that would make study participation unsafe. The study doctor will evaluate other inclusion and exclusion criteria.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    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
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Skillman, New Jersey, United States, 08558
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waco, Texas, United States, 76712
    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
    West Jordan, Utah, United States, 84084
    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
    Cincinnati, Ohio, United States, 45231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tempe, Arizona, United States, 85282
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stockton, California, United States, 95207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gibsonia, Pennsylvania, United States, 15044
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Murray, Utah, United States, 84107
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73104
    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
    Ozark, Alabama, United States, 36360
    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
    Colorado Springs, Colorado, United States, 80907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Germantown, Tennessee, United States, 38138
    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
    Killeen, Texas, United States, 76542
    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
    North Olmsted, Ohio, United States, 44070
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Providence, Rhode Island, United States, 02906
    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
    Long Beach, California, United States, 90808
    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
    Miami, Florida, United States, 33176
    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
    Charlotte, North Carolina, United States, 28204
    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
    Eugene, Oregon, United States, 97401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fountain Valley, California, United States, 92708
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rolla, Missouri, United States, 65401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30060
    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
    Omaha, Nebraska, United States, 68130
    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
    Austin, Texas, United States, 78704
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kenilworth, Illinois, United States, 60043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33613
    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
    Chevy Chase, Maryland, United States, 20815
    Status
    Study Complete
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    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    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
    Philadelphia, Pennsylvania, United States, 19115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    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
    Dallas, Texas, United States, 75231-4307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sylvania, Ohio, United States, 43560
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ithaca, New York, United States, 14850
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77070
    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
    Medford, Oregon, United States, 97504
    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
    Austin, Texas, United States, 78750
    Status
    Study Complete
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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
    North Andover, Massachusetts, United States, 01845
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plano, Texas, United States, 75093
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vista, California, United States, 92083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ocean, New Jersey, United States, 07712
    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
    Lake Oswego, Oregon, United States, 97035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22908
    Status
    Terminated/Withdrawn
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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
    Sarasota, Florida, United States, 34239
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Collegeville, Pennsylvania, United States, 19426
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90095-1752
    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
    Charleston, South Carolina, United States, 29406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ypsilanti, Michigan, United States, 48197
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37421
    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
    2007-16-07

    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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