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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01232322

Enrollment

633

Registered

2010-11-02

Start date

2006-10-31

Completion date

2011-07-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Keywords

bronchial asthma, Pulmicort Respules, long term use, pediatrics

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 5 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	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

Outcome results