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

This study is ongoing, but not recruiting participants.

First Received: November 13, 2008 Last Updated: May 6, 2009 History of Changes

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

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

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

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 ]

Enrollment:	15
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2009
Primary Completion Date:	April 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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males and females between 18 and 45 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin test to grass and/or ragweed antigen.
Positive response to screening nasal challenge.

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

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

No publications provided

Responsible Party:	University of Chicago ( Robert Naclerio, MD )
Study ID Numbers:	16367B (OC 3)
Study First Received:	November 13, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00791973 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Asthmatic Agents

Fluticasone
Rhinitis
Anti-Allergic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions

Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 10, 2009