Predictors of Asthma Exacerbations in Children

Completed

• Conditions: Asthma

• Registration Number: NCT01449435
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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).

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-07
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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
• steroids: 4 weeks
• leukotriene antagonist: 4 weeks

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of exacerbations	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 Outcome Measures

Name	Time	Method
Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP	1 year

Trial Locations

Locations (1)

Goethe University Hospital; 🇩🇪 Frankfurt, Hesse, Germany