Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01203904

Acronym

PEACE-Peds

Enrollment

301

Registered

2010-09-17

Start date

2010-09-30

Completion date

2015-09-30

Last updated

2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Keywords

bronchial asthma, Pulmicort, long term use, pediatrics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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

Countries

Japan

Outcome results