The Effect of Nasal Carbon Dioxide (CO2) Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
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|ClinicalTrials.gov Identifier: NCT00917020|
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : August 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Nasal CO2 Drug: Inactive Placebo Gas||Phase 2|
This randomized, double-blind, placebo-controlled, multi-center, parallel group, pilot study will evaluate the efficacy and safety of as-needed 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 as-needed up to 6 times a day during waking hours (doses must be at least 2 hours apart) for 14 days. Patients will assess their nasal and non-nasal symptoms in a patient diary. Each patient's 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study to Evaluate the Efficacy and Safety of Nasal Carbon Dioxide Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2009|
|Experimental: Active: CO2 Gas||
Drug: Nasal CO2
As-Needed during the 14 day Treatment Period
|Placebo Comparator: Inactive Placebo Gas||
Drug: Inactive Placebo Gas
- To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR). [ Time Frame: 14 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917020
|United States, Missouri|
|Capnia Investigative Site|
|St. Louis, Missouri, United States|
|Study Director:||Anish Bhatnagar, MD||Capnia, Inc.|