Last updated: 11/04/2018 06:56:14

Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

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GSK study ID
FFR101816
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Clinicaltrials.gov ID
NCT00118729
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, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100mcg in Adolescent and Adult Subjects (12 years of age and older) with Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber
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 purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from baseline in subject-rated total nasal symptom score following a single dose of GW685698X aqueous nasal spray during exposure to ragweed pollen over a 12-hour period.

Timeframe: N/A

Secondary outcomes:

Change from baseline in the individual nasal symptom scores of rhinorrhea, nasal congestion, nasal itching and sneezing, assessed hourly during the 12-hour, post-dose exposure period to ragweed pollen in the allergen challenge chamber.

Timeframe: N/A

Interventions:
  • Drug: GW685698X Aqueous Nasal Spray
    • Enrollment:
    380
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    April 2005 to August 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Informed consent
    • Outpatient
    • Significant concomitant medical condition
    • Use of corticosteroids, allergy medications, or tobacco
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Informed consent
    • Outpatient
    • Females must use appropriate contraception
    • Diagnosis of seasonal allergic rhinitis
    • Able to comply with study procedures
    • Literate
    Exclusion criteria:
    • Significant concomitant medical condition
    • Use of corticosteroids, allergy medications, or tobacco
    • Clinically significant abnormal ECG
    • 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
    Woodstock, Georgia, United States, 30188
    Status
    Study Complete
    Contact us

    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
    2005-03-08

    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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