Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

Bronchial Asthma Clinical Trial

Official title:

Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232322
• Other study ID #: D5257L00014
• 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

• Asthma
• Bronchial Asthma

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