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NCT01203904 Clinical Trial

Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

Bronchial Asthma Clinical Trial

— PEACE-Peds  

Official title:
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203904
Other study ID # D525AL00001
Secondary ID
Status Completed
Phase N/A
First received September 6, 2010
Last updated June 6, 2016
Start date September 2010
Est. completion date September 2015

Study information
Verified date June 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 301
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site 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 Hyogo
Japan Research Site Ibaraki
Japan Research Site Iwate
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 Oita
Japan Research Site Okayama
Japan Research Site Osaka
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary Effects on growth rate and the adrenal cortical function, development of infections Two years Yes
Secondary Variation of the asthma control status (total of JPAC:Japanese Pediatric Asthma Control Program score) from the baseline score. Two years No
Secondary Variation of the parental questionnaire (score by factor) from the baseline score. Two years No
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