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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01232322
Other study ID # D5257L00014
Secondary ID
Status Completed
Phase N/A
First received October 31, 2010
Last updated January 23, 2013
Start date October 2006
Est. completion date July 2011

Study information

Verified date January 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria:

- Patients treated with Pulmicort Respules for the first time due to bronchial asthma

- Children of >= 6 months and < 5 years old age at the start of study treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events Range of 3 years Yes
Primary Effects on growth rate Variation of the height/weight from the baseline. Range of 3 years Yes
Primary Effects on the adrenal cortical function. Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort. Range of 3 years Yes
Primary Effects on development of infections. Existence and type of infections. Range of 3 years Yes
Secondary Clinical course under Pulmicort long-term use Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline No
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