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Predictors of Asthma Exacerbations in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01449435
First received: October 7, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Asthma
 Other: Methacholine challenge testing

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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)
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).

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449435

Locations
Germany
Goethe University Hospital
Frankfurt, Hesse, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

Publications:

Responsible Party: Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01449435     History of Changes
Other Study ID Numbers: KGU-238/11
Study First Received: October 7, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Asthma
children
predictors of exacerbation
Methacholine challenge
Pulmonary function testing

Additional relevant MeSH terms:
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
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013