The Effect of Nasal Carbon Dioxide (CO2) in the Symptomatic Treatment of Seasonal Allergic Rhinitis
|Seasonal Allergic Rhinitis||Drug: Nasal CO2 Drug: Inactive Placebo Gas||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide Used Four Times a Day in the Symptomatic Treatment of Seasonal Allergic Rhinitis|
- To assess the efficacy of four times a day treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR). [ Time Frame: 14 Days ]
|Study Start Date:||July 2009|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|Experimental: CO2 Gas||
Drug: Nasal CO2
Four times a day for 14 days
|Placebo Comparator: Inactive Placebo Gas||
Drug: Inactive Placebo Gas
This randomized, double-blind, placebo-controlled, multi-center, parallel group, pilot study will evaluate the efficacy and safety of a four times a day treatment with nasal, non-inhaled administration of CO2 (nasal CO2) in patients with SAR. Approximately 50 patients who meet the eligibility criteria will be enrolled into this study at up to 4 sites to ensure that approximately 30 patients complete the study.
Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser.
All patients will administer study drug for 10 seconds to each nostril once on Day 0 in the clinic then four times a day during waking hours (approximately 4 hours apart) for 14 days. Patients will assess their nasal and non-nasal symptoms in a patient diary. Each patients participation in the study may last up to 72 days.
There will be a total of 5 scheduled clinic visits:
- Visit 1 Screening
- Visit 2 Enrollment (within 42 days of Visit 1)
- Visit 3 Randomization (after the completion of a 3-7 day run-in period)
- Visit 4 Mid-Treatment (Day 7 ± 1 day)
- Visit 5 End of Treatment (within 1-3 days of last study drug administration) Sites will follow-up with randomized patients via telephone 7 ± 1 days after the last study drug administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917111
|United States, Nebraska|
|Capnia Investigative Site|
|Omaha, Nebraska, United States|
|Study Director:||Anish Bhatnagar, MD||Capnia, Inc.|