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NCT01239238 Clinical Trial

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

Asthma Clinical Trial

— RASTER  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01239238
Other study ID # 10-2-064
Secondary ID
Status Completed
Phase N/A
First received October 20, 2010
Last updated November 14, 2013
Start date November 2010
Est. completion date March 2013

Study information
Verified date November 2013
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Maastricht University Hospital Maastricht
Netherlands Orbis Medical Centre Sittard

Sponsors (2)
Lead Sponsor Collaborator
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of exacerbations increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value. 1 year No
Primary asthma control asthma control questionnaire 1 year No
Primary Quality of life Asthma Quality of Life questionnaire for children 1 year No
Secondary cost-effectiveness incremental cost per exacerbation prevented 1 year No
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