The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children
- Conditions
- Intrinsic AsthmaAllergic AsthmaAllergyBronchial Hyperresponsiveness
- Interventions
- Other: methacholine challenge test
- Registration Number
- NCT01144910
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BHR non-atopy methacholine challenge test 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. BHR atopy methacholine challenge test 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.
- Primary Outcome Measures
Name Time Method Change of severe bronchial hyperresponsiveness over time of five years. five years Bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).
- Secondary Outcome Measures
Name Time Method eNO five years Influence of the level of exhaled NO on the time course of BHR.
Bronchial responsiveness of parents two years In parents at first visit bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).
Impact of atopy five years Influence of atopy on the time course of bronchial hyperresponsiveness.
Total-IgE five years Influence of the level of total-IgE on the time course of BHR
Trial Locations
- Locations (1)
Goethe University
🇩🇪Frankfurt am Main, Germany