Last updated: 11/04/2018 07:18:00

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

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GSK study ID
FFU109045
See study documents
Clinicaltrials.gov ID
NCT00435461
See results summary
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 Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
Trial description: The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline over the two-week treatment period in Nighttime Symptoms Score (NSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Secondary outcomes:

Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in D-rTNSS

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from baseline over the two-week treatment period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Peak NasalIinspiratory Flow (PNIF)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Timeframe: Baseline (Day 1) and Day 15

Interventions:
  • Drug: Fluticasone furoate and fexofenadine
    • Enrollment:
    1000
    Primary completion date:
    2007-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Andrews C, Martin B, Jacobs R, Toler T, Prillaman B, Philpot E. Efficacy of fluticasone furoate nasal spray versus oral fexofenadine on nighttime sleep disturbance caused by seasonal allergic rhinitis (SAR) nasal symptoms. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A6 (abstract)
    Andrews CP, Martin BG, Jacobs RL, Diaz J, Toler WT, Prillaman BA, Dalal AA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvement in nocturnal quality of life in subjects with seasonal allergic rhinitis compared with oral fexofenadine. J Allergy Clin Immunol 2008;121(2) (Supplement 1): S53 (abstract)
    Andrews CP, Martin BG, Jacobs RL, Mohar DE, Diaz JD, Amar NJ, Kaiser HB, Vandewalker ML, Bernstein J, Toler WT, Prillaman BA, Dalal AA, Lee LA, Philpot EE.Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy.Allergy Asthma Proc.2009;30(2):128-38
    Martin BG, Andrews CP, Jacobs R, Mohar D, Toler WT, Prillaman BA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvements in relieving nighttime nasal symptoms and increasing peak nasal inspiratory flow versus oral fexofenadine in subjects with seasonal allergic rhinitis (SAR) J Allergy Clin Immunol 2008;121(2) (Supplement 1): S54-S55 (abstract)
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to February 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Informed consent.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Informed consent.
    • Outpatient.
    • Females of child-bearing potential must use appropriate contraception.
    • Diagnosis of seasonal allergic rhinitis to mountain cedar.
    • Adequate exposure to allergen.
    • Able to comply with study procedures.
    • Literate. Exclusion criteria:
    • Significant concomitant medical condition.
    • Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
    • Positive pregnancy test.
    • Allergy to any component of the investigational product.
    • Tobacco use
    • Contact lens use
    • Has chickenpox or measles or recent exposure
    • Other clinical trial drug exposure in last 30 days
    • Affiliation with clinic site

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78731
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kerrville, Texas, United States, 78028
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78750
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Braunfels, Texas, United States, 78130
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-28-02
    Actual study completion date
    2007-28-02

    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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