Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
RASTER
1 other identifier
observational
102
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2010
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 15, 2013
November 1, 2013
2.1 years
October 20, 2010
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
number of exacerbations
increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.
1 year
asthma control
asthma control questionnaire
1 year
Quality of life
Asthma Quality of Life questionnaire for children
1 year
Secondary Outcomes (1)
cost-effectiveness
1 year
Study Arms (1)
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 Criteria
This study is carried out in two hospitals in the Netherlands (Maastricht University Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Maastricht University Hospital
Maastricht, 6202 AZ, Netherlands
Orbis Medical Centre
Sittard, Netherlands
Related Publications (1)
van Vliet D, van Horck M, van de Kant K, Vaassen S, Gulikers S, Winkens B, Rosias P, Heynens J, Muris J, Essers B, Jobsis Q, Dompeling E. Electronic monitoring of symptoms and lung function to assess asthma control in children. Ann Allergy Asthma Immunol. 2014 Sep;113(3):257-262.e1. doi: 10.1016/j.anai.2014.05.015. Epub 2014 Jun 18.
PMID: 24950912DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Dompeling, PhD MD
Maastricht UMC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2010
First Posted
November 11, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
November 15, 2013
Record last verified: 2013-11