Last updated: 11/04/2018 07:00:22

A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

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GSK study ID
FFR30002
See study documents
Clinicaltrials.gov ID
NCT00103454
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, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
Trial description: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
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. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.

Timeframe: N/A

Secondary outcomes:

Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.

Timeframe: N/A

Interventions:
  • Drug: GW685698X
    • Enrollment:
    288
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
    Robert A Nathan, William Berger, William Yang, Amarjit Cheema, Mary Jane Silvey, Wei Wu, Edward Philpot. Effect of once-daily fluticasone furoate nasal spray relieves nasal symptoms in adults and adolescents with perennial allergic rhinitis . Ann Allergy Asthma Immunol. 2008;100(5):497-505.
    Wu W1 Walters RD, Nadeau GA, Botnick W, Broughton N. An integrated analysis of the efficacy of fluticasone furoate nasal spray versus placebo on the individual symptoms of perennial allergic rhinitis. Allergy Asthma Proc. 2013;34(3):283-91.
    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+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of perennial allergic rhinitis (PAR).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of perennial allergic rhinitis (PAR).
    • Must comply with study procedures and be literate. Exclusion criteria:
    • Significant concomitant medical conditions.
    • Use of corticosteroids.
    • Use of allergy medications and some other medications during the study.
    • Current tobacco use.
    • Clinically significant abnormal ECG or laboratory abnormality.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Ocean, New Jersey, United States, 07712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Providence, Rhode Island, United States, 02906
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orange, California, United States, 92868
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Showing 1 - 6 of 49 Results

    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
    2005-02-05

    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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