NCT02377895
Completed
Phase 1
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis
ConditionsSeasonal Allergic Rhinitis
Overview
- Phase
- Phase 1
- Intervention
- Nasapaque Nasal Solution
- Conditions
- Seasonal Allergic Rhinitis
- Sponsor
- 3E Therapeutics Corporation
- Enrollment
- 73
- Primary Endpoint
- TNSS Total Nasal Symptom Score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Nasapaque Nasal Solution
250 ul in each nostril at Day 1 and Day 8
Intervention: Nasapaque Nasal Solution
Placebo Saline Nasal Solution
250 ul in each nostril at Day 1 and Day 8
Intervention: Placebo Saline Nasal Solution
Outcomes
Primary Outcomes
TNSS Total Nasal Symptom Score
Time Frame: Day 1 and Day 8
Secondary Outcomes
- Nasal Inspiratory Flow(Day 1 and Day 8)
- Nasal Inflammation Score(Day 1 and Day 8)
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