Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

October 13, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00435461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Official Title ^ICMJE

A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hayfever
Allergic Rhinitis

Intervention ^ICMJE

Drug: Fluticasone furoate and fexofenadine

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

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

12 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

NCT00435461

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

FFU109045

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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