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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nasapaque Nasal Solution

250 ul in each nostril at Day 1 and Day 8

Group Type EXPERIMENTAL

Nasapaque Nasal Solution

Intervention Type DRUG

Placebo Saline Nasal Solution

250 ul in each nostril at Day 1 and Day 8

Group Type ACTIVE_COMPARATOR

Placebo Saline Nasal Solution

Intervention Type DRUG

Interventions

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Nasapaque Nasal Solution

Intervention Type DRUG

Placebo Saline Nasal Solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No