Fluticasone Nasal Spray Patient Preference Study

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):

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

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