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

This study has been completed.
Sponsor:
Information provided by:
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00638755
First received: March 13, 2008
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Nasal Carbon Dioxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Capnia, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in olfactory test scores post-treatment [ Time Frame: Baseline, Post Treatment: 1 hour & 3 hours ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638755

Locations
United States, Nebraska
Capnia Investigative Site
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Capnia, Inc.
Investigators
Principal Investigator: Capnia Clinical Study Investigator Capnia Investigative Site
  More Information

No publications provided

Responsible Party: Kristen Yen- Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00638755     History of Changes
Other Study ID Numbers: C213
Study First Received: March 13, 2008
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Capnia, Inc.:
Allergic Rhinitis
Perennial Allergic Rhinitis
Allergies to perennial allergens
Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014