At a glance
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A Study to Assess the Market Potential of a Carbon Dioxide Nasal Spray in Congested Subjects
In Brief
A Phase 2 clinical trial evaluating Carbon Dioxide for Nasal Congestion. Completed, enrolled 147 participants across 4 sites.
Detailed Summary
Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic rhinitis have shown that nasally administered CO2 may provide relief of the associated symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration, and may persist for four to six hours. This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who qualify and choose to participate in the clinical study will be administered nasal CO2 under medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and completion of assessment questionnaires.
Study Details
Timeline
Interventions
Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds