The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children
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.
Inclusion Criteria:

 -  informed consent

 -  age 3 to 6 years

 -  diagnosis asthma

 -  pulmonary function: FEV1 (% pred.)≥ 70%

 -  ability to carry out 2 reproducible flow volume loops

 -  moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine)

 -  more than 4 weeks interval since last infection

 -  8 hours washout period of Short Acting Beta Agonist

 -  1 week washout period of Ipratropium Bromide

 -  1 week washout period of Long Acting Beta Agonist

 -  4 weeks washout period of Systemic Corticosteroids

 -  4 weeks washout period of Leukotriene Antagonists

 Exclusion Criteria:

 -  Age < 3 and > 6 Years

 -  Pulmonary function test: FEV1 (% pred.) < 70%

 -  Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)

 -  Incapability to perform spirometry

 -  Current participation in another clinical trial