Last updated: 11/07/2018 16:52:37

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

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GSK study ID
FFU109047
See study documents
Clinicaltrials.gov ID
NCT00502775
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 the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Mean Change from Baseline in the Nighttime Symptom Score (NSS)

Timeframe: Baseline and Weeks 1-2

Secondary outcomes:

Mean Change from Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)

Timeframe: Baseline and Weeks 1-2

Mean Change from Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)

Timeframe: Baseline and Weeks 1-2

Mean Change from Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)

Timeframe: Baseline and Weeks 1-2

Mean Change from Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)

Timeframe: Baseline and Weeks 1-2

Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Timeframe: Baseline, Day 15 or if Early Withdrawal Day

Interventions:
  • Drug: fluticasone furoate, fexofenadine
    • Enrollment:
    680
    Primary completion date:
    2007-18-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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.
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to November 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
    • Otherwise healthy outpatient with mountain cedar allergy
    • Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
    • Age 12 years or older at Visit 2
    • Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
    • Adequate exposure to mountain cedar pollen
    • Ability to comply with study procedures
    • Literate Exclusion criteria:
    • Significant concomitant medical conditions
    • Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
    • Use of other allergy medications within specific timeframes relative to Visit 1
    • Use of other medications that may affect allergic rhinitis or its symptoms
    • Use of immunosuppressive medications eight weeks prior to screening and during the study
    • Immunotherapy patients who are not stable on current dose
    • Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
    • Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
    • Use of contact lenses
    • Recent clinical trial/experimental medication experience within 30 days of Visit 1
    • Subject previously failed the 21-day screen period or failed to complete the treatment period
    • Positive or inconclusive pregnancy test or female who is breastfeeding
    • Employee or relative affiliation with investigational site
    • Current tobacco use
    • Active chickenpox or measles or exposure in the last 3 weeks

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68130
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Albany, Georgia, United States, 31707
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Plymouth, Minnesota, United States, 55441
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 42 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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-18-11
    Actual study completion date
    2007-18-11

    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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