Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
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 two allergy medications are more effective than placebo.
Eligibility Criteria
Inclusion
- Male and female patients 12 years of age and older
- 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
- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT00712920
Start Date
January 1 2007
Last Update
June 8 2011
Active Locations (43)
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1
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
2
Allergy, Asthma and Respiratory Care medical Center
Long Beach, California, United States, 90806
3
Allergy Research Foundation
Los Angeles, California, United States, 90025
4
Southern California Research
Mission Viejo, California, United States, 92691