NCT00688441

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Capnia, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2008-06-03
• Last updated: 2010-08-20