Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation (PEACE-Peds)

June 6, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pulmicort

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Two years
Two years
Effects on growth rate and the adrenal cortical function, development of infections
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.
Time Frame: Two years
Two years
Variation of the parental questionnaire (score by factor) from the baseline score.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Shigeru Yoshida, AstraZenecaKK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 6, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D525AL00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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