Official Title: “Early Diagnosis of Asthma in Young Children”

The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2011

Intervention(s) in this Clinical Trial

• Drug: beclomethasondipropionate
  • 2 x 100 ug dd for two months, via aerochamber

Primary Measures

• - definite asthma diagnosis - biomarkers in exhaled breath
  • Time Frame: 6 years of age
    Safety Issue?: Yes

Inclusion Criteria:

• Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
• Children aged 2-3 years, with no or minor respiratory symptoms

Exclusion Criteria:

• Mental retardation
• Cardiac anomalies
• Congenital malformations
• Other diseases of the lungs/airways
• Chronic systemic inflammatory diseases like M. Crohn
• The inability to perform lung function measurements and/or exhaled air collection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 4 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Maastricht University Medical Center

Overall Clinical Trial Officials and Contacts

Edward Dompeling, dr Principal Investigator Dept. of Paediatric Pulmonology, University Hospital Maastricht  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422747

Study ID Number: NL17407.000.07/2007-001817-40

ClinicalTrials.gov Identifier: NCT00422747

Health Authority: Netherlands: Ministry of Health, Welfare and Sport