Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation
Completed
- Conditions
- Bronchial Asthma
- Registration Number
- NCT01203904
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and \<15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
Inclusion Criteria
- Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
Exclusion Criteria
-None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use. Two years Effects on growth rate and the adrenal cortical function, development of infections Two years
- Secondary Outcome Measures
Name Time Method Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score. Two years Variation of the parental questionnaire (score by factor) from the baseline score. Two years
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamaguchi, Japan