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The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis

Primary Purpose

Perennial Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nasal Carbon Dioxide

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Allergic Rhinitis, Perennial Allergic Rhinitis, Allergies to perennial allergens, Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.
Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.)
Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test

Exclusion Criteria:

History of asthma (other than mild or intermittent)
Clinically significant nasal disorders
Acute or significant sinusitis or upper respiratory infection within 14 days of randomization
Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
Use of certain medication s prior to randomization and during study participation
Participation in prior study with Nasal CO2
Participation in another clinical study within 30 days of planned randomization date and for the duration of the study

Sites / Locations

Capnia Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)

The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)

The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)

The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)

Outcomes

Primary Outcome Measures

Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.

Secondary Outcome Measures

Change from baseline in olfactory test scores post-treatment

TNSS, TNNSS, and TSS comparisons at multiple timepoints

Full Information

NCT ID

NCT00638755

First Posted

March 13, 2008

Last Updated

August 17, 2010

Sponsor

Capnia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00638755

Brief Title

The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of Nasal Carbon Dioxide on Nasal Congestion Via Acoustic Rhinometry in Subjects With Perennial Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

July 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Capnia, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.

Detailed Description

A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis

Keywords

Allergic Rhinitis, Perennial Allergic Rhinitis, Allergies to perennial allergens, Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)

Arm Title

Arm Type

Experimental

Arm Description

The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)

Arm Title

Arm Type

Experimental

Arm Description

The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)

Arm Title

Arm Type

Experimental

Arm Description

The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)

Intervention Type

Drug

Intervention Name(s)

Nasal Carbon Dioxide

Intervention Description

Nasal Carbon Dioxide

Intervention Type

Drug

Intervention Name(s)

Nasal Carbon Dioxide

Intervention Description

Nasal Carbon Dioxide

Intervention Type

Drug

Intervention Name(s)

Nasal Carbon Dioxide

Intervention Description

Nasal Carbon Dioxide

Intervention Type

Drug

Intervention Name(s)

Nasal Carbon Dioxide

Intervention Description

Nasal Carbon Dioxide

Primary Outcome Measure Information:

Title

Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.

Time Frame

Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours

Secondary Outcome Measure Information:

Title

Change from baseline in olfactory test scores post-treatment

Time Frame

Baseline, Post Treatment: 1 hour & 3 hours

Title

TNSS, TNNSS, and TSS comparisons at multiple timepoints

Time Frame

Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy. Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.) Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test Exclusion Criteria: History of asthma (other than mild or intermittent) Clinically significant nasal disorders Acute or significant sinusitis or upper respiratory infection within 14 days of randomization Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study Use of certain medication s prior to randomization and during study participation Participation in prior study with Nasal CO2 Participation in another clinical study within 30 days of planned randomization date and for the duration of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Capnia Clinical Study Investigator

Organizational Affiliation

Capnia Investigative Site

Official's Role

Principal Investigator

Facility Information:

Facility Name

Capnia Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis

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