Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis

Study Overview
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Brief Summary
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The objectives of this study were to: Examine the tolerability of two formulations and two dose concentrations of epinastine. Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study. Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: epinastine 0.1%
* Drug: epinastine 0.1% with taste masking agent
* Drug: epinastine 0.2%
* Drug: epinastine 0.2% with taste masking agent
* Drug: azelastine 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between ages 18-70 history of SAR or PAR for 1 year mild symptoms Exclusion Criteria: asthma or RAD respiratory tract infection within 14 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epinastine 0.1%<br>nasal spray 2 sprays to each nostril for a total of 3 doses | Drug: epinastine 0.1%<br>* nasal spray 2 sprays to each nostril for a total of 3 doses<br>|
| Experimental: epinastine 0.1% with taste masking agent<br>nasal spray 2 sprays to each nostril for a total of 3 doses | Drug: epinastine 0.1% with taste masking agent<br>* nasal spray 2 sprays to each nostril for a total for a 3 doses<br>|
| Experimental: epinastine 0.2%<br>nasal spray 2 sprays to each nostril for a total of 3 doses | Drug: epinastine 0.2%<br>* nasal spray 2 sprays to each nostril for a total of 3 doses<br>|
| Experimental: epinastine 0.2% with taste masking agent<br>nasal spray 2 sprays to each nostril for a total of 3 doses | Drug: epinastine 0.2% with taste masking agent<br>* nasal spray 2 sprays to each nostril for a total of 3 doses<br>|
| Active Comparator: azelastine 0.1%<br>nasal spray 2 sprays in each nostril for a total of 3 doses | Drug: azelastine 0.1%<br>* nasal spray 2 sprays to each nostril for a total of 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall preference rank at the completion of the study using the Overall Nasal Spray Evaluation Questionnaire (NSEQ) |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores from each individual response from the NSEQ of all administered formulations (two formulations and two concentrations of epinastine and azelastine). |  | 2 days |