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

This study has been completed.
Sponsor:
Information provided by:
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00688441
First received: May 29, 2008
Last updated: August 18, 2010
Last verified: August 2010

May 29, 2008
August 18, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688441 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
453
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00688441
C215
No
Kristen Yen, Associate Director, Clinical, Capnia, Inc.
Capnia, Inc.
Not Provided
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