Allergy Clinical Trial
Official title:
A Prospective, Open Label, Single-center Study of the Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children.
The aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. Over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. The investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.
A positive family history with prevalence of atopy, eczema, wheezing are well-known factors
predicting asthma. Caudri et al. found more important predictors like perinatal
transmission, parental use of inhalative medications and wheezing/dyspnea out of viral
infections(5). Measurement of BHR in children was in most studies a second outcome
parameter.
Four visits will be performed, baseline and after 1, 3, and 5 years. At visit 1 the
investigators will characterize all patients by a ISAAC survey. At each visit in children a
methacholine challenge, a skin Prick test, eNO, RAST and total IgE will be performed. At
visit 3 and 4 sputum will be induced. In parents only at the first visit a methacholine
challenge will be performed. A genetic identification of ADAM33 gene from EDTA blood shall
be provided. ADAMs are multidomain proteins with a metalloprotease domain, associated with
airway remodelling. Visits should be kept in a time interval without asthma therapy and
respiratory infection.
To examine the feasibility of methacholine challenges in preschool children data measured in
2006 will be analysed.
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