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

Withdrawn

Conditions: asthma
10024970

Registration Number: NL-OMON30167

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

Two groups are included:
- Children aged 2-3 years, with recurrent respiratory symptoms suggestive of
astma;
- Children aged 2-3 years, with no or minor respiratory symptoms

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter in this study is the definite diagnosis of<br /><br>asthma at the age of 6 years.<br /><br><br /><br><br /><br>Morover, primary parameters are:<br /><br>- Nitric oxide (NO) in exhaled breath<br /><br>- Breathogram of volatile substances in expired air<br /><br>- Exhaled breath condensate<br /><br>- Lungfunction measurements of airway resistance<br /><br>- markers in venous blood for: white blood cell count, differentiation, number<br /><br>of eosinophils, total and specific IgE, cytokine profiles, the presence and<br /><br>function of regulatory T-cells, markers of oxidative stress, gene expression of<br /><br>markers of oxidative stress and inflammation<br /><br>- Respiratory symptoms and quality of life</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters:<br /><br>- asthma medication (dose, period) during the follow-up phase<br /><br>- presence of other allergic diseases like eczema and/or allergic<br /><br>rhinoconjunctivitis<br /><br>- hospital admissions because of respiratory problems</p><br>