The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration...
Date First Received: November 9, 2006
Last Updated: April 8, 2008
Verified by: GlaxoSmithKline, April 2008
Clinical Trial Phase: Phase 3 | Start Date: December 2006
Overall Status: Completed
Estimated Enrollment: 125
Brief Summary
Official Title: “A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis”
Condition Keyword(s):
Intervention(s):
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Intervention(s) in this Clinical Trial
- Drug: fluticasone propionate
- Drug: fluticasone furoate
Outcome Measures for this Clinical Trial
Primary Measures
- overall subject preference for nasal spray
Secondary Measures
- subject preference for individual attributes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- allergic rhinitis
- literate
Exclusion Criteria:
- clinical significant uncontrolled disease
- Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
- Use of intranasal medications <1 week
- Use of meds that significantly inhibit CYP4503A4
- Use of perfume or oral rinse on study day
- Allergy/intolerance to INS, antihistamines, or excipients
- Positive pregnancy test or female who is breastfeeding
- Affiliation with investigational site
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, M.D. Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00398476
Study ID Number: FFU108556
ClinicalTrials.gov Identifier: NCT00398476
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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