Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation
Completed
- Conditions
- Bronchial Asthma
- Registration Number
- NCT01232322
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 633
Inclusion Criteria
- Patients treated with Pulmicort Respules for the first time due to bronchial asthma
- Children of >= 6 months and < 5 years old age at the start of study treatment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Range of 3 years Effects on growth rate Range of 3 years Variation of the height/weight from the baseline.
Effects on the adrenal cortical function. Range of 3 years Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
Effects on development of infections. Range of 3 years Existence and type of infections.
- Secondary Outcome Measures
Name Time Method Clinical course under Pulmicort long-term use Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline