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

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

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Fluticasone furoate and fexofenadine

Primary Measures

• Mean change from baseline over the two-week treatment period in the nighttime symptoms score (NSS)

Secondary Measures

• Mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

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

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 August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00435461

Study ID Number: FFU109045

ClinicalTrials.gov Identifier: NCT00435461

Health Authority: United States: Food and Drug Administration