AsthmaRASTERNCT01239238
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
An observational study of Asthma and Children, run by Maastricht University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma, Children, Home Monitoring
- How many people
- 102 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This study is carried out in two hospitals in the Netherlands (Maastricht University Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University Hospital
Maastricht, 6202 AZ
Orbis Medical Centre
Sittard
About this study
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.
- Conditions
- Asthma, Children, Home Monitoring, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds
- Keywords
- asthma, children, home monitoring, exhaled breath condensate, non-invasive inflammatory markers, volatile organic compounds
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of exacerbations
increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.
Measured: 1 year
asthma control
asthma control questionnaire
Measured: 1 year
Quality of life
Asthma Quality of Life questionnaire for children
Measured: 1 year
Secondary outcomes (1)
cost-effectiveness
incremental cost per exacerbation prevented
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Edward Dompeling, PhD MD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239238
- Sponsor's protocol ID
- 10-2-064
- Acronym
- RASTER
- Status last verified
- Nov 2013
- First submitted
- 20 Oct 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24950912
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
- ClinicalTrials.gov ID
- NCT01239238
- Acronym / sponsor ID
- RASTER / 10-2-064
- Conditions
- Asthma, Children, Home Monitoring, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds
- Keywords
- asthma, children, home monitoring, exhaled breath condensate, non-invasive inflammatory markers, volatile organic compounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study is carried out in two hospitals in the Netherlands (Maastricht University Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of exacerbations
Time frame: 1 year
increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.
asthma control
Time frame: 1 year
asthma control questionnaire
Quality of life
Time frame: 1 year
Asthma Quality of Life questionnaire for children
1 secondary outcome
cost-effectiveness
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
- Derived from this study: PubMed 24950912van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Dompeling, PhD MD principal investigator
Maastricht UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Children, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of exacerbations (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.