A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Official Title
-----------------
Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Placebo nasal spray
* Drug: 0.15% azelastine hydrochloride Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis Must be in generally good health Must meet minimum symptom requirements, as specified in the protocol Must be willing and able to provide informed consent and to participate in all study procedures Positive skin test to a prevalent fall allergen Exclusion Criteria: On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study. Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities. Nasal Surgery or sinus surgery within the previous year Chronic sinusitis-more than 3 episodes a year Planned travel outside of the study area during the study period The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener) Women who are pregnant or nursing Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception Respiratory tract infection within 14 days prior to screening Respiratory tract infections requiring antibiotic treatment 14 days prior to screening Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment Significant pulmonary disease including COPD Clinically significant arrythmia or symptomatic cardiac conditions A known history of alcohol or drug abuse within the last 2 years Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Nasal Spray<br>0mg Placebo Nasal Spray | Drug: Placebo nasal spray<br>* Placebo<br>|
| Active Comparator: 0.15% azelastine hydrochloride nasal spray<br>0.15% azelastine hydrochloride | Drug: 0.15% azelastine hydrochloride Nasal Spray<br>* 0.15% azelastine hydrochloride 822 mcg<br>* Other names: astepro 0.15%;|

What is the study measuring?
-----------------
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 14 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 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 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo | End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Least square means 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 baseline as a covariate. | baseline and 14 days | 
| Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 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. Least square means 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 14-days | 
| Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined) | Reflective secondary symptom 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. Least square means 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 14-days | 
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days | A 28-item RQLQ was completed on Day 1 and Day 14 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. Total overall score is not calculated by adding all subscales scores for an overall score. 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 14 Days | 
| Change From Baseline on Direct Visual Nasal Exams at 14 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 14 days |