Last updated: 11/07/2018 16:43:57

Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

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GSK study ID
FFR103184
See study documents
Clinicaltrials.gov ID
NCT00225823
EudraCT ID
2004-004434-14
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 Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis in Europe
Trial description: Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as ‘hay fever’, it is characterized by 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:

Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).

Timeframe: N/A

Secondary outcomes:

Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.

Timeframe: N/A

Interventions:
  • Drug: GW685698X
    • Enrollment:
    288
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    W. J. Fokkens, R. Jogi, S. Reinartz, I. Sidorenko, B. Sitkauskiene, C. van Oene, M. A. Faris, A. Ellsworth, M. F. Caldwell. Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen . Allergy. September 2007;62, Issue 9:1078 - 1084.
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    May 2005 to August 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Informed consent.
    • Must be an outpatient.
    • A significant concomitant medical condition.
    • Use of corticosteroids or allergy or medications or tobacco.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Informed consent.
    • Must be an outpatient.
    • Females must be using appropriate contraception.
    • Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
    • Must be able to comply with study procedures.
    • Must be literate.
    Exclusion criteria:
    • A significant concomitant medical condition.
    • Use of corticosteroids or allergy or medications or tobacco.
    • Clinically significant abnormal ECG.
    • Laboratory abnormality.
    • Positive pregnancy test.
    • Allergy to any component of the investigational product.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Moscow, Russia, 115446
    Status
    Study Complete
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    Location
    GSK Investigational Site
    ASSEN, Netherlands, 9401 RK
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kaunas, Lithuania, LT-50009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Riga, Latvia, LV 1003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tartu, Estonia, 51014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    TILBURG, Netherlands, 5038 NM
    Status
    Recruiting
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    Showing 1 - 6 of 22 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2005-12-08

    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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