Status:
COMPLETED
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Lead Sponsor:
Alcon Research
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis
Eligibility Criteria
Inclusion
- Inclusion:
- A history of spring/summer seasonal allergies.
- Positive skin prick test for the currently prevalent allergen of the area.
- Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
- For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.
- Exclusion:
- History of chronic sinusitis.
- Asthma, with the exception of intermittent asthma.
- Smokers.
- Known non-responders to antihistamines.
- Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
- Chronic use of long acting antihistamines.
- Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
- Relatives of study site staff or other individuals who had access to the clinical study protocol.
- Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00691665
Start Date
May 1 2008
Last Update
March 30 2010
Active Locations (1)
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1
Sacramento, CA
Sacramento, California, United States, 95819