Seasonal Allergic Rhinitis
Conditions
Keywords
Randomized, Double-Blind, Multi-Center, Phase II, Nasal Carbon Dioxide, Carbon Dioxide, Efficacy, Safety, Total Nasal Symptom Score
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.
Interventions
DRUGNasal CO2
As-Needed during the 14 day Treatment Period
Placebo
Sponsors
Capnia, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following inclusion criteria to be considered eligible for study enrollment: * Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB/EC-approved informed consent form * Males or females ages 18 - 65 years * Able to comply with the requirements of the protocol * Minimal 2-year history of seasonal allergic rhinitis requiring pharmacotherapy * Positive skin test to one or more seasonal allergens prevalent in the respective local geographical area by either prick or intradermal methods within 12 months prior to enrollment * Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile
Exclusion criteria
* Patients must not meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of as-needed treatment with nasal carbon dioxide (CO2) in patients with seasonal allergic rhinitis (SAR). | 14 Days |
Countries
United States
Outcome results
None listed