Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation
This study has been completed.
Information provided by (Responsible Party):
First received: October 31, 2010
Last updated: January 23, 2013
Last verified: January 2013
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics|
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Incidence of Adverse Events [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]
- Effects on growth rate [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]Variation of the height/weight from the baseline.
- Effects on the adrenal cortical function. [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
- Effects on development of infections. [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]Existence and type of infections.
Secondary Outcome Measures:
- Clinical course under Pulmicort long-term use [ Designated as safety issue: No ]Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline
|Study Start Date:||October 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Those with an exposure
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