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

Johann Wolfgang Goethe University Hospital

Status: Withdrawn

Conditions: Bronchial Hyperresponsiveness; Intrinsic Asthma; Allergic Asthma; Allergy

Treatments: Other: methacholine challenge test

Study type: Observational

Funder types: Other

Identifiers

NCT01144910

KGU-317/09

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

BHR non-atopy

Description:

Patients from the outpatient Department of Allergy, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany. Over a time-span of 5 years the investigators will explore the lung function and the bronchial hyperresponsiveness. Bronchial methacholine challenges will be performed at baseline and after 1, 3 and 5 years.

Treatment:

Other: methacholine challenge test

Other: methacholine challenge test

BHR atopy

Description:

Patients from the outpatient Department of Allergy, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany. Over a time-span of 5 years the investigators will explore the lung function and the bronchial hyperresponsiveness. Bronchial methacholine challenges will be performed at baseline and after 1, 3 and 5 years.

Treatment:

Other: methacholine challenge test

Other: methacholine challenge test