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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of Seasonal Allergic Rhinitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capnia, Inc.

Criteria

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