The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
703
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
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
Time frame: Change from baseline to 12 months
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Center of Research Excellence, LLC
Oxford, Alabama, United States
AABI Associates Medical Group
Fountain Valley, California, United States
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, United States
West Coast Clinical Trials
Long Beach, California, United States
Allergy Research Foundation
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
Allergy Associates Medical Group Inc
San Diego, California, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California, United States
Bensch Research Associates
Stockton, California, United States
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