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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01239238
First received: October 20, 2010
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of the present proposal is to improve care to children with asthma by including regular assessments of non-invasive inflammatory markers during the management of asthma. In this case, treatment is also guided by inflammatory markers (besides symptoms and lung function). In case an exacerbation is expected (because of signs of increased airway inflammation), therapy is already increased in order to prevent an exacerbation. When stable disease is present, tapering of medication can occur.


Condition Intervention
Asthma
Children
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds
 Other: non-invasive inflammatory markers in exhaled breath (condensate)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.

  • asthma control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    asthma control questionnaire

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Asthma Quality of Life questionnaire for children


Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    incremental cost per exacerbation prevented


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diagnostic intervention with standard therapy
diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate in addition to symptoms/lung function to guide treatment (active intervention group) compared to usual care (guiding of treatment by symptoms and lung function only). Thus, in the intervention group therapy is guided by symptoms, lung function and inflammatory markers in exhaled breath (condensate).
 Other: non-invasive inflammatory markers in exhaled breath (condensate)
regular assessments of non-invasive inflammatory markers in exhaled breath (condensate) to titrate treatment in children with asthma
Placebo Comparator: lungfunction and asthma symptoms Other: non-invasive inflammatory markers in exhaled breath (condensate)
regular assessments of non-invasive inflammatory markers in exhaled breath (condensate) to titrate treatment in children with asthma

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. already known with a diagnosis of asthma during at least 6 months
  2. age between 6 and 16 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239238

Locations
Netherlands
Maastricht University Hospital
Maastricht, Netherlands, 6202 AZ
Orbis Medical Centre
Sittard, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Edward Dompeling, PhD MD Maastricht UMC
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01239238     History of Changes
Other Study ID Numbers: 10-2-064
Study First Received: October 20, 2010
Last Updated: March 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
asthma
children
exhaled breath condensate
non-invasive inflammatory markers
volatile organic compounds

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013