Fluticasone Nasal Spray Patient Preference Study - Tabular View

Tracking Information

First Received Date ^ICMJE

November 9, 2006

Last Updated Date

April 8, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

overall subject preference for nasal spray

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00398476 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

subject preference for individual attributes

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Fluticasone Nasal Spray Patient Preference Study

Official Title ^ICMJE

A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Drug: fluticasone propionate
Drug: fluticasone furoate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

125

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00398476

Responsible Party

Study ID Numbers ^ICMJE

FFU108556

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP