Status:
COMPLETED
A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Lead Sponsor:
Meda Pharmaceuticals
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
FEMALE
12+ years
Phase:
PHASE3
Brief Summary
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
Eligibility Criteria
Inclusion
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- 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
- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT00719862
Start Date
August 1 2007
End Date
November 1 2007
Last Update
February 2 2010
Active Locations (34)
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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 and Asthma Medical Group and Research Center
San Diego, California, United States, 92123
4
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
San Jose, California, United States, 95117