A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
NCT ID: NCT00712920
Last Updated: 2011-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
581 participants
INTERVENTIONAL
2007-01-31
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
QUADRUPLE
Study Groups
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1
Placebo
Placebo
Placebo
2
0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 1644 mcg
3
0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
0.1% azelastine hydrochloride
0.1% azelastine hydrochloride 1096 mcg
Interventions
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0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 1644 mcg
0.1% azelastine hydrochloride
0.1% azelastine hydrochloride 1096 mcg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in protocol
* Must be willing and able to provide informed consent and participate in all study procedures
* 2-year history of PAR
* Positive skin test to cockroach, dust mite, mold or cat/dog dander
Exclusion Criteria
* Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
* Nasal surgery or sinus surgery within the previous year
* The use of any investigational drug within 30 days
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
* Women who are pregnant or nursing
* Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infection within 2 weeks of screening
* Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
* Patients with asthma with the exception of mild, intermittent
* Significant pulmonary disease including COPD
* Patients with arrhythmia
* Patients with a known history of alcohol or drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
* Clinically relevant abnormal physical findings within one week of randomization
* Overnight abscences from home for more than 3 nights
* Employees of the research center or private practice and family members are excluded
* Patients who received prohibited medications within specified timepoints in protocol.
12 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Meda Pharmaceuticals
Locations
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Allergy and Asthma Specialist Medical Group
Huntington Beach, California, United States
Allergy, Asthma and Respiratory Care medical Center
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 and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
The William Storms Allergy Clinic
Colorodo Springs, Colorado, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Kansas City Allergy and Asthma
Overland Park, Kansas, 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
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
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
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 Consultants of NJ/PA
Collegeville, 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
Central Texas Research
New Braunfels, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy and Asthma Center
Waco, Texas, United States
Virginia Adult & Pediactric Allergy & Asthma, PC
Richmond, Virginia, United States
Asthma, Inc.
Seattle, Washington, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, United States
Countries
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References
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Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023.
Other Identifiers
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MP434
Identifier Type: -
Identifier Source: org_study_id
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