Clinical trial NCT01203904: Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation
Official title: Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: bronchial asthma, Pulmicort, long term use, pediatrics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 301
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Two years
measure: Effects on growth rate and the adrenal cortical function, development of infections
timeFrame: Two years
Secondary outcomes:
measure: Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.
timeFrame: Two years
measure: Variation of the parental questionnaire (score by factor) from the baseline score.
timeFrame: Two years
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZenecaKK
name: Shigeru Yoshida
role: STUDY_DIRECTOR
References: