Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchial Asthma

• Study Type: Observational
• Enrollment (Actual): 633

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of >=6months and <5 years old age at the start of study treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pulmicort Respules; Those with an exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events		Range of 3 years
Effects on growth rate	Variation of the height/weight from the baseline.	Range of 3 years
Effects on the adrenal cortical function.	Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.	Range of 3 years
Effects on development of infections.	Existence and type of infections.	Range of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Yoshida Shigeru, MD, AstraZeneca K.K.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 31, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: pediatrics; long term use; bronchial asthma; Pulmicort Respules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D5257L00014