The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688441
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : August 20, 2010
Information provided by:
Capnia, Inc.

May 29, 2008
June 3, 2008
August 20, 2010
July 2008
October 2008   (Final data collection date for primary outcome measure)
The mean change in reflective Total Nasal Symptom Score (TNSS) over the Treatment Period compared to baseline in nasal CO2 or placebo [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT00688441 on Archive Site
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The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide in the Treatment of Seasonal Allergic Rhinitis
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis
This multi-center, randomized, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in patients with seasonal allergic rhinitis. An estimated 500 patients who meet the eligibility criteria will be enrolled into this study at approximately 25 sites to ensure that approximately 400 patients are randomized and complete the study.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Nasal CO2
    Twice daily during the 14 day Treatment Period
  • Drug: Placebo
    Use of the study drug dispenser at the same frequency as the active arm
  • Experimental: Active
    CO2 Gas
    Intervention: Drug: Nasal CO2
  • Placebo Comparator: Placebo
    Inactive Placebo Gas
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to read and understand informed consent and voluntarily consent to sign the informed consent form
  • Able to comply with the requirements of the protocol (e.g., complete the diary within the protocol-specified window)
  • Minimal 2-year history of Fall seasonal allergic rhinitis requiring pharmacotherapy
  • Positive skin test to one or more Fall seasonal allergen (e.g., ragweed, birch pollen, 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 intermittent)
  • Acute or significant sinusitis or upper respiratory infection within 14 days of enrollment
  • Existing serious medical condition (e.g., severe emphysema) that precludes participation
  • Females who are pregnant or breast-feeding and/or who plan to become pregnant or to breast-feed during the study participation or within 7 days after the last study drug administration
  • Initiation of immunotherapy or have a change in immunotherapy dose within the 6 months preceding enrollment (if on immunotherapy, the same dose must be maintained throughout the trial)
  • Planned travel outside the study area for the duration of study period
  • Participation in another clinical study within 30 days of planned enrollment date and for the duration of the study
  • Participation in a previous study with Nasal CO2
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Kristen Yen, Associate Director, Clinical, Capnia, Inc.
Capnia, Inc.
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Study Chair: S. David Miller, MD Northeast Medical Research Associates, Inc.
Capnia, Inc.
August 2010

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