Last updated: 11/07/2018 16:42:39

Study of GW685698X In Patients With Seasonal Allergic Rhinitis

GSK study ID
FFR100652
See study documents
Clinicaltrials.gov ID
NCT00363740
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: Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 over Fluticasone Propionate Using a Double-blind Manner-
Trial description: This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW685698X Aqueous Nasal Spray
    • Enrollment:
    38
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Keisuke Masuyama, Yoriko Morioka, Terufumi Hara. Drug Use Investigation on Fluticasone Furoate (Allermist®) 27.5 µg 56 Metered Nasal Spray. Allergol Immunol. 2012;19(12):88-101.
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to April 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    16+ years
    Accepts healthy volunteers
    No
    • Informed consent
    • Outpatient
    • Significant concomitant medical condition
    • Use of corticosteroids/allergy medications
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Informed consent
    • Outpatient
    • Diagnosis of seasonal allergic rhinitis with symptoms
    • Able to comply with study procedures
    Exclusion criteria:
    • Significant concomitant medical condition
    • Use of corticosteroids/allergy medications
    • Laboratory abnormality
    • Positive pregnancy test
    • Allergy to any component of investigational product

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us

    Study documents

    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
    2005-13-04

    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

    Additional information
    Not applicable
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