NCT00618410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2014

Completed
Last Updated

January 27, 2014

Status Verified

December 1, 2013

Enrollment Period

2 months

First QC Date

February 6, 2008

Results QC Date

August 28, 2013

Last Update Submit

December 9, 2013

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change From Diluent Challenge Contralateral Secretion Weight at 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.

    10 minutes post diluent challenge and 10 minutes post antigen challenge

Secondary Outcomes (5)

  • Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge

    10 minutes post diluent challenge and 10 minutes post antigen challenge

  • Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge

    10 minutes post diluent challenge and 10 minutes post antigen challenge

  • Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge

    10 minutes post diluent challenge and 10 minutes post antigen challenge

  • Eosinophil Influx [Pre-allergen]

    before antigen challenge

  • Eosinophil Influx [Post-allergen]

    after antigen challenge

Study Arms (2)

Carbon dioxide

ACTIVE COMPARATOR

nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge

Device: Carbon dioxide, USP

Placebo

PLACEBO COMPARATOR

nasal placebo administered 30 minutes prior to nasal challenge

Other: Placebo

Interventions

Carbon dioxide, USPDEVICE

Carbon dioxide (CO2) delivered via a nosepiece at a flow rate of 0.5 (± 0.05) SLPM for 10 seconds /nostril

Carbon dioxide
PlaceboOTHER

Nasal placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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. doi: 10.2500/aap.2011.32.3442.

    PMID: 21703101RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr. Robert M. Naclerio, MD
Organization
The University of Chicago
rnacleri@surgery.bsd.uchicago.edu
(773) 702-1865

Study Officials

  • Robert Naclerio, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

September 1, 2008

Last Updated

January 27, 2014

Results First Posted

January 27, 2014

Record last verified: 2013-12

Locations

US(1)