An early diagnosis of asthma in young children by using non-invasive biomarkers of oxidative stress/airway inflammation, and early lung function measurements - Early diagnosis of asthma in young childre

Conditions: children with recurrent respiratory symptoms)

Registration Number: EUCTR2006-006736-22-NL

Lead Sponsor: etherlands Asthma Foundation (NAF)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Children aged 2-3 years, with recurrent respiratory symptoms suggestive of
astma;
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

mental retardation, cardiac abnormalities, congenital anomalies, other respiratory diseases, chronic inflammatory diseases (e.g. Morbus Crohn, rheumatoid arthritis), inability to perform the exhaled air and lungfunction procedures properly

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: As good responsiveness to corticosteroids is a hallmark of asthma (1), this response is likely able to discriminate between asthmatic children and non-asthmatic subjects. So far, response to inhaled corticosteroids has not been used as a predictor of asthma in studies, although several international guidelines advocate a trial treatment with inhaled corticosteroids for a likely diagnosis of asthma in young children. This study can test whether such guideline advises hold in clinical practice. ;Secondary Objective: ;Primary end point(s): Effects of medication on:<br>- Nitric oxide (NO) in exhaled breath<br>- Breathogram of volatile substances in expired air<br>- Exhaled breath condensate<br>- Lungfunction measurements of airway resistance<br>- Respiratory symptoms and quality of life

Secondary Outcome Measures