Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

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.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of Adverse Events

Time frame: Range of 3 years
Effects on growth rate

Time frame: Range of 3 years

Variation of the height/weight from the baseline.
Effects on the adrenal cortical function.

Time frame: Range of 3 years

Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
Effects on development of infections.

Time frame: Range of 3 years

Existence and type of infections.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Nov 2, 2010
Registry last updated: Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed