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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmicort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria: -None
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Patients treated with Pulmicort Turbuhaler for the firtst time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Yoshida | AstraZenecaKK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| Chiba |
| Japan |
| Research Site | Ehime | Japan |
| Research Site | Fukui | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Fukushima | Japan |
| Research Site | Gifu | Japan |
| Research Site | Gunma | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Kagawa | Japan |
| Research Site | Kagoshima | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kochi | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Nagano | Japan |
| Research Site | Niigata | Japan |
| Research Site | Numakunai | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saga | Japan |
| Research Site | Saitama | Japan |
| Research Site | Shiga | Japan |
| Research Site | Shimane | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tochigi | Japan |
| Research Site | Tokushima | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Tottori | Japan |
| Research Site | Toyama | Japan |
| Research Site | Yamagata | Japan |
| Research Site | Yamaguchi | Japan |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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