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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2008

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.

Interventions

  • Drug: Nasal Carbon Dioxide
    • Nasal Carbon Dioxide
  • Drug: Nasal Carbon Dioxide
    • Nasal Carbon Dioxide
  • Drug: Nasal Carbon Dioxide
    • Nasal Carbon Dioxide
  • Drug: Nasal Carbon Dioxide
    • Nasal Carbon Dioxide

Arms, Groups and Cohorts

  • Experimental: 1
    • The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)
  • Experimental: 2
    • The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)
  • Experimental: 3
    • The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)
  • Experimental: 4
    • The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change from baseline in olfactory test scores post-treatment
    • Time Frame: Baseline, Post Treatment: 1 hour & 3 hours
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Capnia, Inc.
  • Provider of Information About this Clinical Study
    • Kristen Yen- Associate Director, Clinical, Capnia, Inc.
  • Overall Official(s)
    • Capnia Clinical Study Investigator, Principal Investigator, Capnia Investigative Site

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