A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

Study Overview
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Brief Summary
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The purpose of this study is to determine if two allergy medications are more effective than placebo.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 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: 0.1% azelastine hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 12 years of age and older Must be in generally good health Must meet minimum symptom requirements, as specified in protocol Must be willing and able to provide informed consent and participate in all study procedures 2-year history of PAR Positive skin test to cockroach, dust mite, mold or cat/dog dander Exclusion Criteria: On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities Nasal surgery or sinus surgery within the previous year The use of any investigational drug within 30 days Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose Women who are pregnant or nursing Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception Respiratory tract infection within 2 weeks of screening Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening Patients with asthma with the exception of mild, intermittent Significant pulmonary disease including COPD Patients with arrhythmia Patients with a known history of alcohol or drug abuse Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug. Clinically relevant abnormal physical findings within one week of randomization Overnight abscences from home for more than 3 nights Employees of the research center or private practice and family members are excluded Patients who received prohibited medications within specified timepoints in protocol.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br>0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks | Drug: 0.15% azelastine hydrochloride<br>* 0.15% azelastine hydrochloride 1644 mcg<br>|
| Experimental: 3<br>0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks | Drug: 0.1% azelastine hydrochloride<br>* 0.1% azelastine hydrochloride 1096 mcg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. | Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. | baseline and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days | instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. | baseline and 28 days | 
| Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days | Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day. | baseline and 28 days | 
| Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days | A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items. | baseline and 28 Days | 
| Change From Baseline on Direct Visual Nasal Exams and 28 Days | 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 irratation 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 | baseline and 28 days |