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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Allergic Rhinitis
Interventions Device: Carbon dioxide, USP
Other: Placebo
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carbon Dioxide, Then Placebo Placebo, Then Carbon Dioxide
Hide Arm/Group Description

Intervention sequence:

  1. Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
  2. Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge

Intervention sequence:

  1. Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge
  2. Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
Period Title: First Intervention
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Washout Period (2 Weeks)
Started 7 6
Completed 7 5
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Period Title: Second Intervention
Started 7 5
Completed 7 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Study population includes subjects receiving interventions in either order.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
30.69  (8.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
2
  15.4%
Male
11
  84.6%
1.Primary Outcome
Title Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge
Hide Description 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.
Time Frame 10 minutes post diluent challenge and 10 minutes post antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes one patient who did not complete the second crossover intervention.
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: milligrams
6
(-3.1 to 54.1)
19.6
(0 to 55.2)
2.Secondary Outcome
Title Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge
Hide Description 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.
Time Frame 10 minutes post diluent challenge and 10 minutes post antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes one patient who did not complete the second crossover intervention.
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: milligrams
9
(-4.8 to 90.4)
32.6
(0 to 49.7)
3.Secondary Outcome
Title Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge
Hide Description

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.

Time Frame 10 minutes post diluent challenge and 10 minutes post antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes one patient who did not complete the second crossover intervention.
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: ng/mL
0
(-2.7 to 16.6)
2.04
(0 to 10.4)
4.Secondary Outcome
Title Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge
Hide Description

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.

Time Frame 10 minutes post diluent challenge and 10 minutes post antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes one patient who did not complete the second crossover intervention.
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: ng/mL
0
(-1.2 to 1.7)
0
(0 to 9.1)
5.Secondary Outcome
Title Eosinophil Influx [Pre-allergen]
Hide Description The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.
Time Frame before antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: percentage of white blood cells
0
(0 to 0)
0
(0 to 2)
6.Secondary Outcome
Title Eosinophil Influx [Post-allergen]
Hide Description The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.
Time Frame after antigen challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description:
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
nasal placebo administered 30 minutes prior to nasal challenge
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: percentage of white blood cells
0
(0 to 31)
0
(0 to 4)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbon Dioxide Placebo
Hide Arm/Group Description nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge nasal placebo administered 30 minutes prior to nasal challenge
All-Cause Mortality
Carbon Dioxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carbon Dioxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carbon Dioxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert M. Naclerio, MD
Organization: The University of Chicago
Phone: (773) 702-1865
EMail: rnacleri@surgery.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier: NCT00618410     History of Changes
Other Study ID Numbers: 15835A
First Submitted: February 6, 2008
First Posted: February 20, 2008
Results First Submitted: August 28, 2013
Results First Posted: January 27, 2014
Last Update Posted: January 27, 2014