Intranasal CO2 for Allergic Rhinitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by University of Chicago. Recruitment status was Active, not recruiting

First Received on February 6, 2008. Last Updated on May 27, 2008 History of Changes

Sponsor:	University of Chicago
Collaborator:	Capnia, Inc.
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00618410

Purpose

The purpose of this study is to better understand the way in which CO2 (carbon dioxide) affects the symptoms of allergic rhinitis or hayfever.

Our intent is to determine if CO2 has an effect on nasal challenge with antigen as a predictor of whether it will have a beneficial effect on the treatment of seasonal allergic rhinitis.

Condition	Intervention
Allergic Rhinitis	Other: Carbon dioxide, USP Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Intranasal CO2 for Allergic Rhinitis

Resource links provided by NLM:

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

change in the amount of secretions on the contralateral collection discs between the diluent response and the response after antigen [ Time Frame: 10 minutes post antigen challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

histamine release [ Time Frame: following antigen challenge ] [ Designated as safety issue: No ]
eosinophil influx [ Time Frame: following antigen challenge ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A nasal CO2 administered 30 minutes prior to nasal challenge	Other: Carbon dioxide, USP Carbon dioxide (CO2)delivered via a nosepiece at a flow rate of 0.5 (± 0.05) SLPM for 10 seconds /nostril
Placebo Comparator: B nasal placebo administered 30 minutes prior to nasal challenge	Other: Placebo Nasal placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: NCT00618410

Locations

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

Sponsors and Collaborators

University of Chicago

Capnia, Inc.

Investigators

Principal Investigator:

Robert Naclerio, M.D.

University of Chicago

More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baroody FM, Gavanescu L, Wang JH, DeTineo M, Naclerio RM. The effect of intranasal carbon dioxide on the acute response to nasal challenge with allergen. Allergy Asthma Proc. 2011 May-Jun;32(3):206-12.

Responsible Party:	Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00618410 History of Changes
Other Study ID Numbers:	15835A
Study First Received:	February 6, 2008
Last Updated:	May 27, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012