Status:
COMPLETED
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
Lead Sponsor:
AstraZeneca
Conditions:
Hay Fever
Seasonal Allergic Rhinitis
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels on...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- General good health other than seasonal allergic rhinitis
- Positive standard skin prick test
- Main
Exclusion
- Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
- Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
- Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
- Use of any prohibited concomitant medications
- Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
- Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
- Study participation by more than one patient from the same household
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00305487
Start Date
March 1 2006
End Date
October 1 2006
Last Update
November 30 2016
Active Locations (71)
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1
Altana Pharma/Nycomed
Birmingham, Alabama, United States, 35235
2
Altana Pharma/Nycomed
Hot Springs, Arkansas, United States, 71913
3
Altana Pharma/Nycomed
Costa Mesa, California, United States, 92626
4
Altana Pharma/Nycomed
Huntington Beach, California, United States, 92647