A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Official Title
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Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: 0.15% azelastine hydrochloride
* Drug: Mometasone furoate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies. Must be willing and able to provide informed consent and to participate in all study procedures Must be in generally good health Positive skin test to a prevalent perennial allergen Exclusion Criteria: On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation Use of any investigational drug within 30 days of the first visit Any nasal surgery or sinus surgery within the previous year Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose Women who are pregnant or nursing Women who are not using an acceptable method of birth control Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities. Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator. Patients with Arrythmia Patients with know history of alcohol and drug abuse Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study. Use of medications that could affect the study results

Ages Eligible for Study
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Minimum Age: 12 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.15% azelastine hydrochloride 1644 mcg | Drug: 0.15% azelastine hydrochloride<br>* 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM<br>|
| Experimental: 2<br>Mometasone furoate 200 mcg | Drug: Mometasone furoate<br>* 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on Direct Visual Nasal Exams to 12 Months | Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation | Change from baseline to 12 months |