Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation (PEACE-Peds)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01203904
First received: September 6, 2010
Last updated: May 28, 2013
Last verified: May 2013
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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 |
|---|
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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 ]
| Enrollment: | 301 |
| 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) |
| Groups/Cohorts |
|---|
| Pulmicort |
Eligibility| Ages Eligible for Study: | 5 Years to 14 Years |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203904
Locations
| Japan | |
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| Aichi, Japan | |
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| Chiba, Japan | |
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| Ehime, Japan | |
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| Fukui, Japan | |
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| Fukuoka, Japan | |
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| Fukushima, Japan | |
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| Gifu, Japan | |
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| Gunma, Japan | |
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| Hiroshima, Japan | |
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| Hokkaido, Japan | |
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| Hyogo, Japan | |
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| Ibaraki, Japan | |
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| Iwate, Japan | |
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| Kagawa, Japan | |
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| Kagoshima, Japan | |
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| Kanagawa, Japan | |
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| Kochi, Japan | |
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| Kyoto, Japan | |
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| Mie, Japan | |
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| Miyagi, Japan | |
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| Nagano, Japan | |
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| Niigata, Japan | |
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| Oita, Japan | |
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| Okayama, Japan | |
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| Osaka, Japan | |
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| Saga, Japan | |
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| Saitama, Japan | |
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| Shiga, Japan | |
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| Shimane, Japan | |
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| Shizuoka, Japan | |
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| Tochigi, Japan | |
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| Tokushima, Japan | |
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| Tokyo, Japan | |
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| Tottori, Japan | |
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| Toyama, Japan | |
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| Yamagata, Japan | |
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| 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: | May 28, 2013 |
| 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013