Last updated: 11/07/2018 16:41:46

Seasonal Allergic Rhinitis In Pediatric Subjects

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GSK study ID
FFR100010
See study documents
Clinicaltrials.gov ID
NCT00107757
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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years with Seasonal Allergic Rhinitis (SAR)
Trial description: The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW685698X
    • Enrollment:
    576
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    EO Meltzer, J Lee, I Tripathy, J Lim, A Ellsworth, E Philpot. Efficacy and safety of once-daily fluticasone furoate nasal spray in children with seasonal allergic rhinitis treated for 2 weeks. Pediatric Allergy and Immunology. 2009;20(3):279–286.
    Meltzer EO, Tripathy I, Máspero JF, Wu W and Philpot EE. Safety and Tolerability of Fluticasone Furoate Nasal Spray Once Daily in Pediatric Patients Aged 6 to 11 Years with Allergic Rhinitis. Clin Drug Invest. 2009;29(2):79-86.
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    March 2005 to November 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 12 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of seasonal allergic rhinitis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of seasonal allergic rhinitis.
    • Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area. Exclusion criteria:
    • Have significant concomitant medical conditions.
    • Use of corticosteroids, other allergy meds during the study.
    • Have abnormal ECG or laboratory abnormality.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Warrensburg, Missouri, United States, 64093
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Costa Mesa, California, United States, 92626
    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
    Canton, Ohio, United States, 44718
    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
    Brockton, Massachusetts, United States, 02301
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 65 Results

    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
    2005-01-11

    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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