Predictors of Asthma Exacerbations in Children
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| ClinicalTrials.gov Identifier: NCT01449435 |
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Recruitment Status :
Completed
First Posted : October 10, 2011
Last Update Posted : April 25, 2013
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| Condition or disease | Intervention/treatment |
|---|---|
| Asthma | 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).
| Study Type : | Observational |
| Actual Enrollment : | 75 participants |
| Observational Model: | Case-Crossover |
| Time Perspective: | Prospective |
| Official Title: | Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
- Other: Methacholine challenge testing
Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mgOther Name: Aerosol Provocation System (Cardinal Health GmbH)
- 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.
- Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 4 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449435
| Germany | |
| Goethe University Hospital | |
| Frankfurt, Hesse, Germany, 60590 | |
| Responsible Party: | Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University Hospital |
| ClinicalTrials.gov Identifier: | NCT01449435 |
| Other Study ID Numbers: |
KGU-238/11 |
| First Posted: | October 10, 2011 Key Record Dates |
| Last Update Posted: | April 25, 2013 |
| Last Verified: | April 2013 |
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Asthma children predictors of exacerbation Methacholine challenge Pulmonary function testing |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Methacholine Chloride Miotics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |