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

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

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

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Nasal Carbon Dioxide

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Capnia Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)	Drug: Nasal Carbon Dioxide; Nasal Carbon Dioxide
EXPERIMENTAL: 2; The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)	Drug: Nasal Carbon Dioxide; Nasal Carbon Dioxide
EXPERIMENTAL: 3; The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)	Drug: Nasal Carbon Dioxide; Nasal Carbon Dioxide
EXPERIMENTAL: 4; The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)	Drug: Nasal Carbon Dioxide; Nasal Carbon Dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the dose-related effects of CO2 on nasal congestion assessed by acoustic rhinometry.	Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in olfactory test scores post-treatment	Baseline, Post Treatment: 1 hour & 3 hours
TNSS, TNNSS, and TSS comparisons at multiple timepoints	Baseline, Post Treatment: 15 mins, 30 mins, 45 mins, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, 24 hours

Collaborators and Investigators

• Sponsor: Capnia, Inc.
• Investigators: Principal Investigator: Capnia Clinical Study Investigator, Capnia Investigative Site

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion: July 1, 2008

Study Registration Dates

• First Submitted: March 13, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (ESTIMATE): March 19, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 19, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Perennial Allergic Rhinitis; Allergies to perennial allergens; Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: C213