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

Phase 3

Completed

Interventions: Drug: 0.15% azelastine hydrochloride
Drug: Mometasone furoate

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	0.15% azelastine hydrochloride	0.15% azelastine hydrochloride 1644 mcg
2	Mometasone furoate	Mometasone furoate 200 mcg

Primary Outcome Measures

Name	Time	Method
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Change from baseline 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

Secondary Outcome Measures

Name	Time	Method

Locations (58): 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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Center of Research Excellence, LLC
🇺🇸Oxford, Alabama, United States