Trial Outcomes & Findings for Intranasal CO2 for Allergic Rhinitis (NCT NCT00618410)
NCT ID: NCT00618410
Last Updated: 2014-01-27
Results Overview
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.
COMPLETED
NA
13 participants
10 minutes post diluent challenge and 10 minutes post antigen challenge
2014-01-27
Participant Flow
Participant milestones
| Measure |
Carbon Dioxide, Then Placebo
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
|
Placebo, Then Carbon Dioxide
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
|
|---|---|---|
|
First Intervention
STARTED
|
7
|
6
|
|
First Intervention
COMPLETED
|
7
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period (2 Weeks)
STARTED
|
7
|
6
|
|
Washout Period (2 Weeks)
COMPLETED
|
7
|
5
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
7
|
5
|
|
Second Intervention
COMPLETED
|
7
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Carbon Dioxide, Then Placebo
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
|
Placebo, Then Carbon Dioxide
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
|
|---|---|---|
|
Washout Period (2 Weeks)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Intranasal CO2 for Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=13 Participants
Study population includes subjects receiving interventions in either order.
|
|---|---|
|
Age, Continuous
|
30.69 years
STANDARD_DEVIATION 8.13 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 10 minutes post diluent challenge and 10 minutes post antigen challengePopulation: Excludes one patient who did not complete the second crossover intervention.
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.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge
|
6 milligrams
Interval -3.1 to 54.1
|
19.6 milligrams
Interval 0.0 to 55.2
|
SECONDARY outcome
Timeframe: 10 minutes post diluent challenge and 10 minutes post antigen challengePopulation: Excludes one patient who did not complete the second crossover intervention.
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.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge
|
9 milligrams
Interval -4.8 to 90.4
|
32.6 milligrams
Interval 0.0 to 49.7
|
SECONDARY outcome
Timeframe: 10 minutes post diluent challenge and 10 minutes post antigen challengePopulation: Excludes one patient who did not complete the second crossover intervention.
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.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge
|
0 ng/mL
Interval -2.7 to 16.6
|
2.04 ng/mL
Interval 0.0 to 10.4
|
SECONDARY outcome
Timeframe: 10 minutes post diluent challenge and 10 minutes post antigen challengePopulation: Excludes one patient who did not complete the second crossover intervention.
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.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge
|
0 ng/mL
Interval -1.2 to 1.7
|
0 ng/mL
Interval 0.0 to 9.1
|
SECONDARY outcome
Timeframe: before antigen challengeThe number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Eosinophil Influx [Pre-allergen]
|
0 percentage of white blood cells
Interval 0.0 to 0.0
|
0 percentage of white blood cells
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: after antigen challengeThe number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.
Outcome measures
| Measure |
Carbon Dioxide
n=12 Participants
nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
|
Placebo
n=12 Participants
nasal placebo administered 30 minutes prior to nasal challenge
|
|---|---|---|
|
Eosinophil Influx [Post-allergen]
|
0 percentage of white blood cells
Interval 0.0 to 31.0
|
0 percentage of white blood cells
Interval 0.0 to 4.0
|
Adverse Events
Carbon Dioxide
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place