Status:
COMPLETED
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
Lead Sponsor:
AstraZeneca
Conditions:
Rhinitis, Allergic, Seasonal
Hay Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of seasonal allergic...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- General good health
- History of SAR to short ragweed pollen for 2 years immediately preceding the study
- Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test
- Main
Exclusion
- Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery
- Known hypersensitivity to any corticosteroid
- History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit
- History of alcohol or drug abuse within 2 years preceding the Screening Visit
- Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs
- Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit
- Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00384475
Start Date
October 1 2006
End Date
January 1 2007
Last Update
November 30 2016
Active Locations (1)
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1
Altana Pharma/Nycomed
Ontario, Mississauga, Canada, L4W 1N2