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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

2

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

Group Type EXPERIMENTAL

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

3

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

Group Type EXPERIMENTAL

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

4

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

Group Type EXPERIMENTAL

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

Interventions

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Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

Intervention Type DRUG

Nasal Carbon Dioxide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No