Status:
COMPLETED
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
Lead Sponsor:
AstraZeneca
Conditions:
Perennial Allergic Rhinitis
Allergic Rhinitis
Eligibility:
All Genders
6-11 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 perennial allergi...
Eligibility Criteria
Inclusion
- Main
- General good health, other than perennial allergic rhinitis
- History and diagnosis of perennial allergic rhinitis by skin prick test
- Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
- Main
Exclusion
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
- Use of any prohibited concomitant medications as defined by the study protocol
- Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00163514
Start Date
May 1 2004
End Date
July 1 2005
Last Update
December 2 2016
Active Locations (74)
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1
Altana Pharma/Nycomed
Oxford, Alabama, United States, 36203
2
Altana Pharma/Nycomed
Huntington Beach, California, United States, 92647
3
Altana Pharma/Nycomed
Mission Viejo, California, United States, 92691
4
Altana Pharma/Nycomed
Newport Beach, California, United States, CA 92660