Last updated: 11/07/2018 16:44:32

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)

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GSK study ID
FFR104861
See study documents
Clinicaltrials.gov ID
NCT00197262
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, Single-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 mcg for 2 Weeks in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis
Trial description: Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW685698X Aqueous Nasal Spray
    • Enrollment:
    288
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kaiser HB, Naclerio RM, Given J, Philpot E, Toler T, Ellsworth A. Once-daily fluticasone furoate* nasal spray (FFNS) is effective for the treatment of seasonal allergic rhinitis (SAR) caused by ragweed. *USAN-approved name. J Allergy Clin Immunol. 2007;
    Kaiser HB, Naclerio RM, Given J, Toler T, Ellsworth A, Philpot EE. Fluticasone furoate nasal spray: A single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007;119:1430-1437.
    Naclerio R, Kaiser H, Lumry W, Philpot E, Toler T, Ellsworth A. Fluticasone furoate nasal spray provided 24-hr relief of nasal and ocular symptoms of seasonal allergic rhinitis (SAR) caused by ragweed. Allergy 2007;62(Suppl. 83): 134 (abstract).
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to October 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must be outpatients.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must be outpatients.
    • Diagnosis of SAR.
    • Literate in English or native language. Exclusion criteria:
    • Have a significant concomitant medical condition.
    • Use corticosteroids or other allergy medications during the study.
    • Use tobacco products.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Rolla, Missouri, United States, 65401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Missouri, United States, 65203
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Allis, Wisconsin, United States, 53227
    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
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Showing 1 - 6 of 17 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
    2005-18-10

    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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