Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00917020
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2009-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Nasal Carbon Dioxide (CO2) Used As-Needed in the Symptomatic Treatment of Seasonal Allergic Rhinitis
Sponsor:
Capnia, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of as-needed treatment with nasal carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: