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

January 25, 2017 updated by: 3E Therapeutics Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasapaque Nasal Solution
250 ul in each nostril at Day 1 and Day 8
Drug: Nasapaque Nasal Solution
Active Comparator: Placebo Saline Nasal Solution
250 ul in each nostril at Day 1 and Day 8
Drug: Placebo Saline Nasal Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TNSS Total Nasal Symptom Score
Time Frame: Day 1 and Day 8
Day 1 and Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Nasal Inspiratory Flow
Time Frame: Day 1 and Day 8
Day 1 and Day 8
Nasal Inflammation Score
Time Frame: Day 1 and Day 8
Day 1 and Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3E Therapeutics Corporation

Collaborators

ORA, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-100-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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