Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Fluticasone propionate Fexofenadine Fluticasone Fexofenadine hydrochloride

U.S. FDA Resources

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
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Fluticasone furoate and fexofenadine

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00435461 History of Changes
Other Study ID Numbers:	FFU109045
Study First Received:	February 14, 2007
Last Updated:	October 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

allergic rhinitis
mountain cedar
once daily
fluticasone furoate
fexofenadine

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Fexofenadine
Terfenadine
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012