Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation
PEACE-Peds
1 other identifier
observational
301
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 7, 2016
June 1, 2016
5 years
September 6, 2010
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (1)
Pulmicort
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Aichi, Japan
Research Site
Chiba, Japan
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Ehime, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Kagawa, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kyoto, Japan
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Mie, Japan
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Miyagi, Japan
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Nagano, Japan
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Niigata, Japan
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Numakunai, Japan
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Okayama, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Tottori, Japan
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Toyama, Japan
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Yamagata, Japan
Research Site
Yamaguchi, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shigeru Yoshida
AstraZenecaKK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2010
First Posted
September 17, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 7, 2016
Record last verified: 2016-06