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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009579-36-NL
Enrollment
Unknown
Registered
2009-07-03
Start date
2009-10-20
Completion date
Unknown
Last updated
2012-03-19

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

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: 12.0 Level: LLT Classification code 1

Interventions

Trade Name: QVAR Pharmaceutical Form: Inhalation powder Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use

Sponsors

None listed

Eligibility

Sex/Gender
All

Inclusion criteria

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: 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)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026