Back to resultsAllergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nasapaque Nasal Solution
Placebo Saline Nasal Solution
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nasapaque Nasal Solution
Placebo Saline Nasal Solution
Arm Description
250 ul in each nostril at Day 1 and Day 8
250 ul in each nostril at Day 1 and Day 8
Outcomes
Primary Outcome Measures
TNSS Total Nasal Symptom Score
Secondary Outcome Measures
Nasal Inspiratory Flow
Nasal Inflammation Score
Full Information
NCT ID
NCT02377895
First Posted
February 27, 2015
Last Updated
January 25, 2017
Sponsor
3E Therapeutics Corporation
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02377895
Brief Title
Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3E Therapeutics Corporation
Collaborators
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasapaque Nasal Solution
Arm Type
Experimental
Arm Description
250 ul in each nostril at Day 1 and Day 8
Arm Title
Placebo Saline Nasal Solution
Arm Type
Active Comparator
Arm Description
250 ul in each nostril at Day 1 and Day 8
Intervention Type
Drug
Intervention Name(s)
Nasapaque Nasal Solution
Intervention Type
Drug
Intervention Name(s)
Placebo Saline Nasal Solution
Primary Outcome Measure Information:
Title
TNSS Total Nasal Symptom Score
Time Frame
Day 1 and Day 8
Secondary Outcome Measure Information:
Title
Nasal Inspiratory Flow
Time Frame
Day 1 and Day 8
Title
Nasal Inflammation Score
Time Frame
Day 1 and Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30881050
Citation
Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.
Results Reference
derived
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Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
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