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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Waco, Texas, United States, 76712
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    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
    2007-16-07

    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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