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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: January 16, 2012
Last verified: January 2012
History of Changes

September 6, 2010
January 16, 2012
September 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01203904 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Bronchial Asthma
Not Provided
Pulmicort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
301
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01203904
D525AL00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida AstraZenecaKK
AstraZeneca
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP