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Completed

NCT Number: NCT01239238

Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study

The purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home monitor assessments to measure asthma control will be examined.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Hospital, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • already known with a diagnosis of asthma during at least 6 months
  • age between 6 and 17 years
  • reversibility to a bronchodilator (increase in FEV1 > 9% of predicted value and/or
  • bronchial hyperresponsiveness to histamine < 8 mg/ml.

Exclusion criteria

  • cardiac abnormalities
  • mental retardation, congenital abnormalities or existence of a syndrome
  • active smoking
  • no technical satisfactory performance of measurements
  • no phone line or internet assess available at home.

Treatment and study plan

Primary outcomes

  1. number of exacerbations

    Time frame: 1 year

    increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.

  2. asthma control

    Time frame: 1 year

    asthma control questionnaire

  3. Quality of life

    Time frame: 1 year

    Asthma Quality of Life questionnaire for children

Secondary outcomes

  1. cost-effectiveness

    Time frame: 1 year

    incremental cost per exacerbation prevented

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: RASTER

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 11, 2010
Registry last updated
Nov 15, 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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