Last updated: 11/07/2018 16:42:02

A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics

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GSK study ID
FFR100012
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Clinicaltrials.gov ID
NCT00116883
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 controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in children 2 to 11 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 GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.
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:
    Meltzer EO, Tripathy I, Máspero JF, Wu W and Philpot EE. Safety and Tolerability of Fluticasone Furoate Nasal Spray Once Daily in Pediatric Patients Aged 6 to 11 Years with Allergic Rhinitis. Clin Drug Invest. 2009;29(2):79-86.
    Tripathy I, Levy A, Ratner P, Clements D, Wu W and Philpot E. HPA axis safety of fluticasone furoate nasal spray once daily in children with perennial allergic rhinitis. Pediatric Allergy and Immunology. 2009;20(3):287–294.
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    February 2005 to July 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    2 - 11 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis and history of perennial allergic rhinitis.
    Inclusion and exclusion criteria
    Inclusion 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:
    • Significant concurrent medical conditions.
    • Certain medications such as corticosteroids and allergy medications.

    Trial location(s)

    Location
    Status
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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
    Long Beach, California, United States, 90806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hot Springs, Arkansas, United States, 71913
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33409
    Status
    Terminated/Withdrawn
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    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
    2005-07-07

    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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