A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal 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 (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Detailed Description
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This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray. Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.

Official Title
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Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Placebo
* Drug: azelastine Hcl
* Drug: azelastineHcl / fluticasone propionate
* Drug: fluticasone propionate


Participation Criteria
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Eligibility Criteria
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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 wiling and able to provide informed consent and to participate all study procedures Positive skin test to a prevalent spring allergen Exclusion criteria: On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum Nasal or sinus surgery within the previous 6 months Chronic sinus infection (more than 3 per year) Planned travel outside the study area during the study period Use of any investigational drug within 30 days of the first visit Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase) Women who are not using an acceptable method or birth control Women who are pregnant or nursing Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator Irregular heartbeat or other symptomatic heart conditions History of alcohol or drug abuse History of glaucoma 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluticasone propionate<br> | Drug: fluticasone propionate<br>* fluticasone propionate 200 mcg<br>* Other names: fluticasone;|
| Experimental: azelastineHcl/fluticasone propionate<br> | Drug: azelastineHcl / fluticasone propionate<br>* azelastine Hcl 548 mcg / fluticasone propionate 200 mcg<br>* Other names: MP29-02;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo<br>|
| Active Comparator: azelastine Hcl<br> | Drug: azelastine Hcl<br>* azelastine Hcl 548 mcg<br>* Other names: azelastine;|

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 (rTNSS) | change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result. | days 1 to 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result. | day 1 to day 14 | 
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result. | day 1 to day 14 |