Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
Lead Sponsor:
Meda Pharmaceuticals
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
703 Patients enrolled
Trial Details
Trial ID
NCT00720382
Start Date
March 1 2007
End Date
July 1 2008
Last Update
May 21 2015
Active Locations (59)
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1
Center of Research Excellence, LLC
Oxford, Alabama, United States, 36203
2
AABI Associates Medical Group
Fountain Valley, California, United States, 92708
3
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
4
West Coast Clinical Trials
Long Beach, California, United States, 90806