Goethe University Hospital
Frankfurt am Main, Hesse, 60590, Germany
NCT Number: NCT01449435
The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.
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Notify Me4 year–6 year
All sexes
Observational
Frankfurt am Main, Hesse, 60590, Germany
Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these parameters will be evaluated in prospective design.
One hundred children will be included in the study. Baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. If the patients fulfill the criteria for an exacerbation the children will present in our department. We expect that 44% of the children have an exacerbation. All children will present at a second visit after one year (visit 2).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
Other names: Aerosol Provocation System (Cardinal Health GmbH)
Time frame: 1 year
An exacerbations is defined as an increased need of salbutamol (more than two puffs per week or more than five puffs per two weeks). In this case patients will be followed up at our hospital and will start an anti-inflammatory therapy, if it is necessary.
Time frame: 1 year
Johann Wolfgang Goethe University Hospital
Other
Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors
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