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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
History of Changes

March 13, 2008
August 17, 2010
February 2008
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00638755 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
Drug: Nasal Carbon Dioxide
Nasal Carbon Dioxide
  • Experimental: 1
    The following treatment sequence: A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo)
    Intervention: Drug: Nasal Carbon Dioxide
  • Experimental: 2
    The following treatment sequence: B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide)
    Intervention: Drug: Nasal Carbon Dioxide
  • Experimental: 3
    The following treatment sequence: C (Nasal Carbon Dioxide), D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide)
    Intervention: Drug: Nasal Carbon Dioxide
  • Experimental: 4
    The following treatment sequence: D (placebo), A (Nasal Carbon Dioxide), B (Nasal Carbon Dioxide), C (Nasal Carbon Dioxide)
    Intervention: Drug: Nasal Carbon Dioxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00638755
C213
No
Kristen Yen- Associate Director, Clinical, Capnia, Inc.
Capnia, Inc.
Not Provided
Principal Investigator: Capnia Clinical Study Investigator Capnia Investigative Site
Capnia, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP