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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01203904
First received: September 6, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition
Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Effects on growth rate and the adrenal cortical function, development of infections [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Variation of the asthma control status (total of JPAC:Japanese Pediatric Asthma Control Program score) from the baseline score. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Variation of the parental questionnaire (score by factor) from the baseline score. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203904

Locations
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, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida AstraZenecaKK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01203904     History of Changes
Other Study ID Numbers: D525AL00001
Study First Received: September 6, 2010
Last Updated: September 22, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
bronchial asthma, Pulmicort, long term use, pediatrics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014