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

November 14, 2013 updated by: Maastricht University Medical Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Maastricht University Hospital
      • Sittard, Netherlands
        • Orbis Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study is carried out in two hospitals in the Netherlands (Maastricht University Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Care as usual
Therapy is guided based on symptoms and lung function. Assessments: home monitoring, symptoms, lung function, FeNO, asthma control, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of exacerbations
Time Frame: 1 year
increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.
1 year
asthma control
Time Frame: 1 year
asthma control questionnaire
1 year
Quality of life
Time Frame: 1 year
Asthma Quality of Life questionnaire for children
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost-effectiveness
Time Frame: 1 year
incremental cost per exacerbation prevented
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Edward Dompeling, PhD MD, Maastricht UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (ESTIMATE)

November 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-2-064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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