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Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hayfever; Allergic Rhinitis

Intervention: Fluticasone furoate and fexofenadine (Drug)

Phase: Phase 4

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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 Investigational Site, Austin, Texas 78731, United States

GSK Investigational Site, Austin, Texas 78750, United States

GSK Investigational Site, Kerrville, Texas 78028, United States

GSK Investigational Site, New Braunfels, Texas 78130, United States

GSK Investigational Site, San Antonio, Texas 78205, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

Additional Information

Starting date: December 2006
Last updated: October 1, 2010

Page last updated: August 23, 2015

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