Intranasal Steroids and the Nasal Ocular Response - Full Text View

Sponsors and Collaborators:	University of Chicago GlaxoSmithKline
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00473915

Purpose

Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.

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

MedlinePlus related topics: Hay Fever

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Intranasal Steroids Prevent Antigen-Induced Hyperresponsiveness of the Nasal Ocular Response

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Change in ocular symptoms [ Time Frame: between days 1 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of eosinophils [ Time Frame: between days 1 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

corticosteroid nasal spray

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: NCT00473915

Locations

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

Sponsors and Collaborators

University of Chicago

GlaxoSmithKline

Investigators

Principal Investigator:

Robert m Naclerio, MD

University of Chicago

More Information

Responsible Party:	University of Chicago ( Robert Naclerio, MD )
Study ID Numbers:	15061B
Study First Received:	May 14, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00473915
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal

Hypersensitivity, Immediate
Fluticasone
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009