Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hayfever; Allergic Rhinitis
Intervention: Fluticasone furoate and fexofenadine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
The primary objective of this study is to compare the nighttime symptom relief of fluticasone
furoate nasal spray and oral fexofenadine
Clinical Details
Official title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Mean change from baseline over the two-week treatment period in the nighttime
symptoms score (NSS)
Secondary outcome: 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)
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Austin, Texas 78731, United States
GSK Clinical Trials Call Center, Austin, Texas 78750, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, New Braunsfels, Texas 78130, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78205, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Kerrville, Texas 78028, United States
Additional Information
Starting date: December 2006
Last updated: April 8, 2008
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