Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

This study is not yet open for participant recruitment.

Verified by University of Chicago, November 2008

Sponsors and Collaborators:	University of Chicago GlaxoSmithKline
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00791973

Purpose

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: fluticasone furoate Drug: fluticasone furoate placebo	Phase IV

Drug Information available for: Fluticasone Fluticasone propionate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

Further study details as provided by University of Chicago:

Primary Outcome Measures:

The primary endpoint will be the difference in change in the level of tryptase after antigen challenge between fluticasone furoate and placebo [ Time Frame: following antigen challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The difference in change in symptom scores after antigen challenge between fluticasone furoate and placebo [ Time Frame: following antigen challenge ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	November 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator fluticasone furoate nasal spray once daily for a week	Drug: fluticasone furoate 2 puffs in each nostril once daily for 1 week
2: Placebo Comparator	Drug: fluticasone furoate placebo 2 puffs in each nostril once daily for 1 week

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791973

Contacts

Contact: Marcy deTineo, BSN

773-702-5889

Locations

United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

GlaxoSmithKline

Investigators

Principal Investigator:

Robert Naclerio, MD

University of Chicago

More Information

Responsible Party:	University of Chicago ( Robert Naclerio, MD )
Study ID Numbers:	16367B (OC 3)
Study First Received:	November 13, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00791973
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Fluticasone
Rhinitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009