Breath Analysis in Children by New Point-of-care Instruments

Asthma Clinical Trial

Official title:

The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377686
• Other study ID #: NL 53995.068.15
• Status: Completed
• Phase: N/A
• First received: January 29, 2016
• Last updated: December 18, 2017
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children aged 6 to 16 years

• Healthy group: See exclusion criteria

• Asthma group: Doctor's diagnosed asthma

• Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis

Exclusion criteria

• Recent course of prednisone or antibiotics (< 1 month before test)

• Passive smoking

• Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)

• Healthy children:

• No current or history of respiratory symptoms

• No current or history of allergic rhinitis

Related Conditions & MeSH terms

• Asthma
• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• inflammation markers in exhaled breath
non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.
Secondary	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.	Measurements will be analysed within 6 to 12 months
Secondary	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.	Measurements will be analysed within 6 to 12 months
Secondary	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.	Measurements will be analysed within 6 to 12 months
Secondary	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.	Measurements will be analysed within 6 to 12 months