Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

AstraZeneca633 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

633

Conditions

Bronchial Asthma

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Adverse Events

Time frame: Range of 3 years

Effects on growth rate

Variation of the height/weight from the baseline.

Time frame: Range of 3 years

Effects on the adrenal cortical function.

Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.

Time frame: Range of 3 years

Effects on development of infections.

Existence and type of infections.

Time frame: Range of 3 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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