Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis

3E Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo Saline Nasal Solution; Drug: Nasapaque Nasal Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02377895

14-100-0008

Details and patient eligibility

About

Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Nasapaque Nasal Solution

Experimental group

Description:

250 ul in each nostril at Day 1 and Day 8

Treatment:

Drug: Nasapaque Nasal Solution

Placebo Saline Nasal Solution

Active Comparator group

Description:

250 ul in each nostril at Day 1 and Day 8

Treatment:

Drug: Placebo Saline Nasal Solution