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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 has been completed.
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: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition
Asthma
Children
Home Monitoring
Exhaled Breath Condensate
Non-invasive Inflammatory Markers
Volatile Organic Compounds

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:


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


Enrollment: 102
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: November 14, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on November 20, 2014