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

Completed · Phase 3

Conditions studied: Perennial Allergic Rhinitis

In brief

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

Key facts

Study ID

NCT00720382

Run by

Meda Pharmaceuticals

People needed

703

Starts

2007-03-01

Expected to finish

2008-07-01

Last updated by the study team

2015-05-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Center of Research Excellence, LLC — Oxford, Alabama, United States

Full record on ClinicalTrials.gov

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