Official Title: “A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis”

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: fluticasone furoate
• Drug: fexofenadine
• Drug: placebo

Primary Measures

• Mean Change From Baseline in the Nighttime Symptom Score (NSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
  • Time Frame: Baseline and Weeks 1-2
    Safety Issue?: No
• Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
  • Time Frame: Baseline, Day 15 or if Early Withdrawal Day
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00502775

Study ID Number: FFU109047

ClinicalTrials.gov Identifier: NCT00502775

Health Authority: United States: Food and Drug Administration