Predictors of Asthma Exacerbations in Children
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.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors|
- Number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Other: Methacholine challenge testing
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449435
|Goethe University Hospital|
|Frankfurt, Hesse, Germany, 60590|