A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT ID: NCT00719862
Last Updated: 2010-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
481 participants
INTERVENTIONAL
2007-08-31
2007-11-30
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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Placebo Nasal Spray
0mg Placebo Nasal Spray
Placebo nasal spray
Placebo
0.15% azelastine hydrochloride nasal spray
0.15% azelastine hydrochloride
0.15% azelastine hydrochloride Nasal Spray
0.15% azelastine hydrochloride 822 mcg
Interventions
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Placebo nasal spray
Placebo
0.15% azelastine hydrochloride Nasal Spray
0.15% azelastine hydrochloride 822 mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in the protocol
* Must be willing and able to provide informed consent and to participate in all study procedures
* Positive skin test to a prevalent fall allergen
Exclusion Criteria
* Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
* Nasal Surgery or sinus surgery within the previous year
* Chronic sinusitis-more than 3 episodes a year
* Planned travel outside of the study area during the study period
* The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
* Respiratory tract infection within 14 days prior to screening
* Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
* Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
* Significant pulmonary disease including COPD
* Clinically significant arrythmia or symptomatic cardiac conditions
* A known history of alcohol or drug abuse within the last 2 years
* Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
* Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
12 Years
FEMALE
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Medical and Scientific Affairs
Principal Investigators
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Lewis M Fredane, MD
Role: STUDY_DIRECTOR
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 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
Colorado Allergy and Asthma centers, PC
Lakewood, Colorado, United States
University of South Florida
Tampa, Florida, United States
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, 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
RX R+D
Metairie, Louisiana, United States
Chesapeake Clinical Research, Inc
Baltimore, Maryland, United States
Institute for Asthma and Allergy PC
Wheaton, Maryland, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, 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
Allergy Consultants PA
Verona, New Jersey, United States
AAIR Research Center
Rochester, New York, United States
OIAA Clinical Research, LLC
Edmond, Oklahoma, United States
Asthma and Allergy Research Associates
Chester, Pennsylvania, United States
Valley Clinical Research
Easton, Pennsylvania, United States
UPMC-ENT
Pittsburgh, Pennsylvania, United States
Asthma, Nasal Disease & Allergy Research Center of New England
Providence, Rhode Island, United States
Pharmaceutical Research & Consulting Inc
Dallas, Texas, United States
Jane Lee, MD, PA Research Center
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Allergy Asthma Research Institute
Waco, Texas, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, United States
Allergy and Asthma Center of Michigan
Novi, Wisconsin, United States
Countries
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Other Identifiers
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MP439
Identifier Type: -
Identifier Source: org_study_id
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