A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
NCT ID: NCT00720382
Last Updated: 2015-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
703 participants
INTERVENTIONAL
2007-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
0.15% azelastine hydrochloride 1644 mcg
0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
2
Mometasone furoate 200 mcg
Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Interventions
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0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lewis M. Fredane, MD
Role: STUDY_DIRECTOR
Meda Pharmaceuticals
Locations
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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
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
Allergy and Asthma Care of Florida
Ocala, Florida, United States
Allergy and Asthma DTC
Tallahassee, Florida, United States
Georgia Pollens Clinical Research Centers Inc
Albany, Georgia, United States
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, United States
RX R+D
Metairie, Louisiana, United States
Institute for Asthma and Allergy PC
Wheaton, Maryland, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
The Asthma and Allergy Center
Papillion, Nebraska, United States
Las Vegas Physicians Research Group
Henderson, Nevada, United States
Allergy and Asthma Research NJ inc
Mount Laurel, New Jersey, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Dr. Perin
Teaneck, New Jersey, United States
Medical Research Associates of CNY, PLLC
North Syracuse, New York, United States
AAIR Research Center
Rochester, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
New Horizon's Clinical Research
Cincinnati, Ohio, United States
Oklahoma Institute of Allergy and Asthma Clinical
Edmond, Oklahoma, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Allergy and Asthma Specialist PC
Blue Bell, Pennsylvania, United States
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 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
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, United States
Allergy and Asthma Associates
Austin, Texas, United States
AARA Research Center
Dallas, Texas, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
SWAAA Research Center
Houston, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
VA Adult and Pediatric Allergy and Asthma
Richmond, Virginia, United States
Asthma, Inc.
Seattle, Washington, United States
Advanced Healthcare
Milwaukee, Wisconsin, United States
Countries
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References
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Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Kumar Ramalingam R, Canonica GW, Berger WE. In perennial allergic rhinitis, RQLQ is improved similarly by Azelastine 0.15 and mometasone furoate. World Allergy Organ J. 2025 Jan 8;18(1):101021. doi: 10.1016/j.waojou.2024.101021. eCollection 2025 Jan.
Other Identifiers
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MP436
Identifier Type: -
Identifier Source: org_study_id
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