Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.|
- Proportion of Patients With Adverse Events [ Time Frame: Follow-up visit at 3 - 5 weeks after treatment initiation ] [ Designated as safety issue: Yes ]An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.
|Study Start Date:||December 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Those with allergic rhinitis or chronic idiopathic urticaria.
2.5 ml (1.25 mg) once daily
Pediatric patients aged 1-5 years