Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00435461

Purpose

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

Condition	Intervention	Phase
Hayfever Allergic Rhinitis	Drug: Fluticasone furoate and fexofenadine	Phase IV

MedlinePlus related topics: Hay Fever

Drug Information available for: Fluticasone Fluticasone propionate Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	1000
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435461

Locations

United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Kerrville, Texas, United States, 78028
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
New Braunfels, Texas, United States, 78130
GSK Investigational Site
Austin, Texas, United States, 78731

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFU109045
Study First Received:	February 14, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00435461
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

allergic rhinitis
mountain cedar
once daily
fluticasone furoate
fexofenadine

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Rhinitis
Histamine
Hypersensitivity
Terfenadine
Respiratory Tract Diseases
Respiratory Tract Infections

Rhinitis, Allergic, Seasonal
Fexofenadine
Hypersensitivity, Immediate
Fluticasone
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases

Pharmacologic Actions
Histamine Antagonists
Autonomic Agents
Therapeutic Uses
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 13, 2009