Status:
COMPLETED
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
Lead Sponsor:
Capnia, Inc.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT00688441
Start Date
July 1 2008
End Date
November 1 2008
Last Update
August 20 2010
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