A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- Registration Number
- NCT00720382
- Lead Sponsor
- Meda Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 703
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (58)
Allergy and Asthma DTC
🇺🇸Tallahassee, Florida, United States
Allergy and Consultants of NJ/PA
🇺🇸Collegeville, Pennsylvania, United States
Pharmaceutical Research & Consulting Inc
🇺🇸Dallas, Texas, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Asthma, Inc.
🇺🇸Seattle, Washington, United States
AABI Associates Medical Group
🇺🇸Fountain Valley, California, United States
Center of Research Excellence, LLC
🇺🇸Oxford, Alabama, United States
West Coast Clinical Trials
🇺🇸Long Beach, California, United States
Allergy Associates Medical Group Inc
🇺🇸San Diego, California, United States
Allergy and Asthma Specialist Medical Group
🇺🇸Huntington Beach, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Allergy Research Foundation
🇺🇸Los Angeles, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
🇺🇸San Jose, California, United States
Allergy and Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Asthma and Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Allergy and Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Allergy and Asthma Care of Florida
🇺🇸Ocala, Florida, United States
RX R+D
🇺🇸Metairie, Louisiana, United States
Georgia Pollens Clinical Research Centers Inc
🇺🇸Albany, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Kansas City Allergy and Asthma
🇺🇸Overland Park, Kansas, United States
Aeroallergy Research Laboratories of Savannah
🇺🇸Savannah, Georgia, United States
Sneeze, Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
Institute for Asthma and Allergy PC
🇺🇸Wheaton, Maryland, United States
Asthma and Allergy Research Associate
🇺🇸Upland, Pennsylvania, United States
Asthma, Nasal Disease & Allergy Research Center of New England
🇺🇸Providence, Rhode Island, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Live Oak Allergy and Asthma Clinic
🇺🇸San Antonio, Texas, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
The Asthma and Allergy Center
🇺🇸Papillion, Nebraska, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
SWAAA Research Center
🇺🇸Houston, Texas, United States
Allergy and Asthma Associates
🇺🇸Austin, Texas, United States
VA Adult and Pediatric Allergy and Asthma
🇺🇸Richmond, Virginia, United States
Allergy and Asthma Research NJ inc
🇺🇸Mount Laurel, New Jersey, United States
The Clinical Research Center
🇺🇸St. Louis, Missouri, United States
Atlantic Research Center
🇺🇸Ocean, New Jersey, United States
Dr. Perin
🇺🇸Teaneck, New Jersey, United States
Oklahoma Institute of Allergy and Asthma Clinical
🇺🇸Edmond, Oklahoma, United States
Allergy Asthma and Dermatology Research
🇺🇸Lake Oswego, Oregon, United States
Medical Research Associates of CNY, PLLC
🇺🇸North Syracuse, New York, United States
Allergy and Asthma Specialist PC
🇺🇸Blue Bell, Pennsylvania, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
New Horizon's Clinical Research
🇺🇸Cincinnati, Ohio, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
National Allergy, Asthma and Urticaria of Charleston
🇺🇸Charleston, South Carolina, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Las Vegas Physicians Research Group
🇺🇸Henderson, Nevada, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Advanced Healthcare
🇺🇸Milwaukee, Wisconsin, United States