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

NCT03377686 | Completed DMC

• 1 other identifier: NL 53995.068.15
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Cystic Fibrosis

Keywords

paediatrics; breath analysis; volatile organic compounds; respiratory diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.

  Measurements will be analysed within 6 to 12 months

• Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.

  Measurements will be analysed within 6 to 12 months

• Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.

  Measurements will be analysed within 6 to 12 months

• Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.

  Measurements will be analysed within 6 to 12 months

Study Arms (3)

Asthma

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

Cystic fibrosis

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

Healthy

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

Interventions

inflammation markers in exhaled breath DIAGNOSTIC_TEST

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

Asthma; Cystic fibrosis; Healthy

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Children aged 6 to 16 years

You may not qualify if:

• Asthma group: Doctor's diagnosed asthma
• Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

• Bannier MAGE, van de Kant KDG, Jobsis Q, Dompeling E. Feasibility and diagnostic accuracy of an electronic nose in children with asthma and cystic fibrosis. J Breath Res. 2019 May 8;13(3):036009. doi: 10.1088/1752-7163/aae158.

  PMID: 30213921 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

inflammation markers in exhaled breath

MeSH Terms

Conditions

Asthma; Cystic Fibrosis; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Edward Dompeling, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: December 19, 2017
• Study Start: March 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)