Breath Analysis in in Adults With Cystic Fibrosis (CF)

Study Overview
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Brief Summary
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Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients with age and gender-matched healthy adults in order to identify a disease-specific exhaled breath pattern as well as to gain insight into pathophysiological and microbial contributions to exhaled breath composition.

Detailed Description
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Although there is some evidence that breath composition reflects aspects of CF pathology, so far a disease-specific molecular breath profile has not been identified. Real-time, whole breath analysis incorporating all of the thousands of potentially relevant volatile compounds is needed in order to identify reliable CF-specific breath patterns. These may be used in future clinical applications to greatly enhance cost-effectiveness and simplicity of diagnostic testing for CF.

Official Title
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Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Venous blood markers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of cystic fibrosis (for CF-patients) Age ≥ 18 years Exclusion Criteria: Previous lung transplantation (for CF-patients) Pulmonary exacerbation within the preceding 6 weeks (for CF-patients) Moribund or severe disease prohibiting protocol adherence (for CF-patients) Respiratory illness requiring physician consultation within the preceding 6 weeks (for controls) Chronic respiratory illness (for controls) Physical or intellectual impairment precluding informed consent or protocol adherence Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystic Fibrosis<br>Breath test and venous blood markers in cystic fibrosis patients | Other: Venous blood markers<br>* Routine venous blood sampling<br>|
| Active Comparator: Control<br>Breath test and venous blood markers in healthy subjects | Other: Venous blood markers<br>* Routine venous blood sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) | Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs) | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of clinical records | Clinical data assessed via questionaire, venous blood markers (clinical routine markers), sputum culture results (clinical routine bacteriology) (results to be reported as a single value for each Arm/Group) | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breath Tests