An observational study in Asthma and Cystic Fibrosis, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Maastricht University Medical Center · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies in Asthma by Maastricht University Medical Center — 1 open to participants now, 1 under way, none of them phase 3. Asthma · Maastricht University Medical Center.
Among the 11 studies in Asthma by Maastricht University Medical Center, this one is the only one that started in 2016, is one of 5 observational ones, and was the 10th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →1 of the 11 studies in Asthma by Maastricht University Medical Center is open now, in 1 country. Recruiting first, the newest first:
Maastricht University Medical Center · Sites in Netherlands
Ages 18–70
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2016.
This study's enrollment of 56 is below the median of 159 across 1,252 observational studies indexed under Asthma.
Median enrollment 100 across the 6 interventional studies, 100 across the 5 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 113 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Asthma by Maastricht University Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.
Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.
Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).
Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.
Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.
Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Healthy children:
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with doctor's diagnosed asthma
Diagnostic Test: inflammation markers in exhaled breath
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years with CF
Diagnostic Test: inflammation markers in exhaled breath
Inflammation markers in exhaled breath will be used in 20 children aged 6 to 16 years old without respiratory diseases
Diagnostic Test: inflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)
Number of participants with adverse events directly related to the various point-of-care tests used
Any adverse event of any kind will be noted. Furthermore, each participant will be asked whether the test was easy to perform. This question can be answered on a 5-point scale (0=totally agree that test was easy to perform, 4= totally disagree that test was easy to perform)
Time frame: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once.
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.
Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.
Aeonose eNose measurements will be analysed by in house software program (Aethena) developed by eNose company (Zutphen, Netherlands). To test sensitivity and specificity, first an area under the receiver operating curve must be calculated with the aforementioned software program. Hereafter sensitivity and specificity of the eNose can be calculated.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.
IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between asthma and healthy children can be calculated.
Time frame: Measurements will be analysed within 6 to 12 months
Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.
IMS measurements will be analysed by software program developed for using IMS data (Visual Now, Ganshorn, Dortmund, Germany). By IMS different VOCs peaks are generated. By using the aforementioned software, these peaks can be analysed and sensitivity and specificity between CF and healthy children can be calculated.
Time frame: Measurements will be analysed within 6 to 12 months
Plan to share: No
Ran from Mar 2016 to primary completion in Nov 2017, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center →