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Predictors of Asthma Exacerbations in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449435
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : April 25, 2013
Information provided by (Responsible Party):
Johannes Schulze MD, 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.

Condition or disease Intervention/treatment
Asthma Other: Methacholine challenge testing

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Other: Methacholine challenge testing
    Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
    Other Name: Aerosol Provocation System (Cardinal Health GmbH)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP [ Time Frame: 1 year ]

Information from the National Library of Medicine

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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
Study Population
Outpatients of departement of Pediatric Pulmonology and Allergology.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01449435

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Goethe University Hospital
Frankfurt, Hesse, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital

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Responsible Party: Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University Hospital 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
Keywords provided by Johannes Schulze MD, Johann Wolfgang Goethe University Hospital:
predictors of exacerbation
Methacholine challenge
Pulmonary function testing
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Methacholine Chloride
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action