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Completed

NCT Number: NCT01449435

Predictors of Asthma Exacerbations in Children

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methacholine challenge testing

Other

Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg

Other names: Aerosol Provocation System (Cardinal Health GmbH)

Primary outcomes

  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 outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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