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Completed

NCT Number: NCT01203904

Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

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.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Effects on growth rate and the adrenal cortical function, development of infections

    Time frame: Two years

Secondary outcomes

  1. Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.

    Time frame: Two years

  2. Variation of the parental questionnaire (score by factor) from the baseline score.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PEACE-Peds

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2010
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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