Effectiveness of inhaled corticosteroids in preschool children following hospital admission for acute dyspnea and wheeze - ICS@ADP

• Conditions: Dyspnea and wheeze in young children:Symptoms of dyspnea and wheeze occur frequently in young children. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections. The majority of children have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma.; MedDRA version: 12.0Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-009579-36-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
-Children that are admitted to the paediatric ward of the Isala Klinieken in Zwolle for the first time with acute dyspnea and wheezing.
-Age 1 - 4 years.
-Child and parents must understand the Dutch language well
-Informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
-Previous use of medication different than short-acting ß2-agonists before hospital admission
-Proven RSV bronchiolitis
-Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether inhaled corticosteroids after a first hospital admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these complaints in children aged 1 to 4 years. ;Secondary Objective: -;Primary end point(s): The primary outcomes is the number of unscheduled doctor visits for dyspnea and wheezing. The secondary outcome are the PACQLQ scores and the use of additional asthma medication, which can be prescribed by the attending physician throughout the study period.