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Intranasal CO2 for Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00618410
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Collaborator:
Capnia, Inc.
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago

Brief Summary:

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 or disease Intervention/treatment Phase
Allergic Rhinitis Device: Carbon dioxide, USP Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Intranasal CO2 for Allergic Rhinitis
Study Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Carbon dioxide
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
Device: 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: Placebo
nasal placebo administered 30 minutes prior to nasal challenge
Other: Placebo
Nasal placebo




Primary Outcome Measures :
  1. Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge [ Time Frame: 10 minutes post diluent challenge and 10 minutes post antigen challenge ]
    Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Contralateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.


Secondary Outcome Measures :
  1. Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge [ Time Frame: 10 minutes post diluent challenge and 10 minutes post antigen challenge ]
    Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Ipsilateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.

  2. Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge [ Time Frame: 10 minutes post diluent challenge and 10 minutes post antigen challenge ]

    After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.

    Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.

    The number reported in this outcome measure was calculated by subtracting the ipsalateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative.


  3. Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge [ Time Frame: 10 minutes post diluent challenge and 10 minutes post antigen challenge ]

    After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.

    Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.

    The number reported in this outcome measure was calculated by subtracting the contralateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative.


  4. Eosinophil Influx [Pre-allergen] [ Time Frame: before antigen challenge ]
    The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.

  5. Eosinophil Influx [Post-allergen] [ Time Frame: after antigen challenge ]
    The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618410


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Capnia, Inc.
Investigators
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Principal Investigator: Robert Naclerio, M.D. University of Chicago

Publications of Results:
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Responsible Party: Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00618410     History of Changes
Other Study ID Numbers: 15835A
First Posted: February 20, 2008    Key Record Dates
Results First Posted: January 27, 2014
Last Update Posted: January 27, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases