Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

N/ACompletedNCT01203904

AstraZeneca301 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

301

Conditions

Bronchial Asthma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (37)

Research Site

Aichi, Japan

Outcomes

Primary Outcomes

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.

Time frame: Two years

Effects on growth rate and the adrenal cortical function, development of infections

Time frame: Two years

Secondary Outcomes

Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.

Time frame: Two years

Variation of the parental questionnaire (score by factor) from the baseline score.

Time frame: Two years

Data from ClinicalTrials.gov

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