Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
Phase 1
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: Placebo Saline Nasal SolutionDrug: Nasapaque Nasal Solution
- Registration Number
- NCT02377895
- Lead Sponsor
- 3E Therapeutics Corporation
- Brief Summary
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria
- Must be 18 years of age and provide written informed consent and sign the HIPAA form
- Must have history of allergic rhinitis
- Must have positive response to Allergen BioCube
Key
Exclusion Criteria
- Must not have a significant illness such as moderate to severe allergic asthmatic reactions
- Must not have compromised lung function
- Must not use any disallowed medications
- Must not have been in an investigational study in the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline Nasal Solution Placebo Saline Nasal Solution 250 ul in each nostril at Day 1 and Day 8 Nasapaque Nasal Solution Nasapaque Nasal Solution 250 ul in each nostril at Day 1 and Day 8
- Primary Outcome Measures
Name Time Method TNSS Total Nasal Symptom Score Day 1 and Day 8
- Secondary Outcome Measures
Name Time Method Nasal Inspiratory Flow Day 1 and Day 8 Nasal Inflammation Score Day 1 and Day 8