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
    • Diagnosis of seasonal allergic rhinitis.
    • Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.
    • Have significant concomitant medical conditions.
    • Use of corticosteroids, other allergy meds during the study.
    Inclusion and exclusion 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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    Location
    GSK Investigational Site
    Richland, Michigan, United States, 49083
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72202
    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
    Indianapolis, Indiana, United States, 46208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hackensack, New Jersey, United States, 07601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    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
    Durham, North Carolina, United States, 27710
    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
    Long Beach, California, United States, 90806
    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
    Englewood, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cudahy, California, United States, 90201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203-1424
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80526
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cranberry Township, Pennsylvania, United States, 16066
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Scottsdale, Arizona, United States, 85251
    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
    Ypsilanti, Michigan, United States, 48197
    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
    Greenfield, Wisconsin, United States, 53228
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    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
    Gainesville, Georgia, United States, 30501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stockbridge, Georgia, United States, 30281
    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
    Altoona, Pennsylvania, United States, 16601
    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
    Charleston, South Carolina, United States, 29406
    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
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mineola, New York, United States, 11501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71105
    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
    Raleigh, North Carolina, United States, 27607
    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
    Denver, Colorado, United States, 80206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Dartmouth, Massachusetts, United States, 02747
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Massachusetts, United States, 01107
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Topeka, Kansas, United States, 66606
    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
    Tampa, Florida, United States, 33613
    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
    Centennial, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jackson, Mississippi, United States, 39202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Utica, New York, United States, 13502
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lakewood, Colorado, United States, 80401
    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
    Madison, Wisconsin, United States, 53792
    Status
    Study Complete
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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
    Walnut Creek, California, United States, 94598
    Status
    Terminated/Withdrawn
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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
    Lawrenceville, Georgia, United States, 30045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37922
    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
    Woodstock, Georgia, United States, 30188
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orange, California, United States, 92868
    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
    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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