Last updated: 11/04/2018 06:59:54

A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

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GSK study ID
FFR20002
See study documents
Clinicaltrials.gov ID
NCT00116818
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, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of fluticasone furoate aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR)
Trial description: The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

Timeframe: N/A

Secondary outcomes:

Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Timeframe: N/A

Interventions:
  • Drug: GW685698X aqueous nasal spray
    • Enrollment:
    90
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).
    Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg
    Deepen Patel, Paul Ratner, Diane Clements, Wei Wu, Melissa Faris, Edward Philpot. Lack of effect on adult and adolescent HPA axis function with use of fluticasone furoate nasal spray. Ann Allergy Asthma Immunol. 2008;100(5):490-496.
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to May 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 65 years
    Accepts healthy volunteers
    No
    • Diagnosis and history of perennial allergic rhinitis.
    • Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
    • Use of tobacco products.
    • Work a rotating shift.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis and history of perennial allergic rhinitis.
    • Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
    • Must comply with all study procedures and be literate.
    Exclusion criteria:
    • Use of tobacco products.
    • Work a rotating shift.
    • Significant concurrent medical conditions.
    • Certain medications such as corticosteroids and allergy medications.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Mississauga, Ontario, Canada, L4W 1N2
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    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
    2005-31-05

    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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    Additional information
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