Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Lead Sponsor:
Meda Pharmaceuticals
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
Detailed Description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, si...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 wiling and able to provide informed consent and to participate all study procedures
- Positive skin test to a prevalent spring allergen
- Exclusion criteria:
- On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
- Nasal or sinus surgery within the previous 6 months
- Chronic sinus infection (more than 3 per year)
- Planned travel outside the study area during the study period
- Use of any investigational drug within 30 days of the first visit
- Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
- Women who are not using an acceptable method or birth control
- Women who are pregnant or nursing
- Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
- Irregular heartbeat or other symptomatic heart conditions
- History of alcohol or drug abuse
- History of glaucoma
- Use of medications that could affect the study results
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT00651118
Start Date
March 1 2008
End Date
July 1 2008
Last Update
September 26 2012
Active Locations (43)
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1
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States, 85251
2
Clinical Research Center
Encinitas, California, United States, 92024
3
Allergy Research Foundation
Los Angeles, California, United States, 90025
4
Southern California Research
Mission Viejo, California, United States, 92691