Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Johann Wolfgang Goethe University Hospital
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of exacerbations
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Johannes Schulze MD
Cosultant Pediatric Allergy and Pulmonolgy
Johann Wolfgang Goethe University Hospital
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •Age \>3 and \<7 years
- •Diagnosis of intermittent asthma
- •In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
- •The ability to perform three reproducible spirometries
- •Examination in infection-free interval (\> 4 weeks infection-free)
- •Minimum distance to the following asthma medications:
- •Short-acting beta 2-agonists: 8 hours
- •Ipratropium bromide: 24 hours
- •Long-acting beta 2-agonists: 24 hours
Exclusion Criteria
- •Age older than 6 years or younger than 4
- •The inability to perform spirometry
- •Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
- •Participation in another study
Outcomes
Primary Outcomes
Number of exacerbations
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.
Secondary Outcomes
- Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP(1 year)