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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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

Keywords

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asthma children home monitoring exhaled breath condensate non-invasive inflammatory markers volatile organic compounds

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Dompeling, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

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Maastricht University Hospital

Maastricht, , Netherlands

Site Status

Orbis Medical Centre

Sittard, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 24950912 (View on PubMed)

Other Identifiers

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10-2-064

Identifier Type: -

Identifier Source: org_study_id