asthma
Conditions
Interventions
A trial with inhaled corticosteroids is part of the diagnosis phase of this
study. Children in the experimental group will enter a controlled crossover
trial with inhaled corticosteroids. This trial
Sponsors
Academisch Ziekenhuis Maastricht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters: - asthma medication (dose, period) during the follow-up phase - presence of other allergic diseases like eczema and/or allergic rhinoconjunctivitis - hospital admissions because of respiratory problems | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the definite diagnosis of asthma at the age of 6 years. Morover, primary parameters are: - Nitric oxide (NO) in exhaled breath - Breathogram of volatile substances in expired air - Exhaled breath condensate - Lungfunction measurements of airway resistance - markers in venous blood for: white blood cell count, differentiation, number of eosinophils, total and specific IgE, cytokine profiles, the presence and function of regulatory T-cells, markers of oxidative stress, gene expression of markers of oxidative stress and inflammation - Respiratory symptoms and quality of life | — |
Countries
Netherlands
Outcome results
None listed