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

Completed

• Conditions: Non-invasive Inflammatory Markers; Asthma; Children; Volatile Organic Compounds; Home Monitoring; Exhaled Breath Condensate

• Registration Number: NCT01239238
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness	1 year	incremental cost per exacerbation prevented

Trial Locations

Locations (2)

Orbis Medical Centre; 🇳🇱 Sittard, Netherlands

Maastricht University Hospital; 🇳🇱 Maastricht, Netherlands