Breath Analysis in in Adults With Cystic Fibrosis (CF)
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT02209571
- Lead Sponsor
- University of Zurich
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Clinical diagnosis of cystic fibrosis (for CF-patients)
- Age ≥ 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) up to 2 years Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
- Secondary Outcome Measures
Name Time Method Composite of clinical records up to 2 years 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)
Trial Locations
- Locations (1)
University Hospital Zurich, Pulmonary Division
🇨🇭Zurich, Switzerland
University Hospital Zurich, Pulmonary Division🇨🇭Zurich, Switzerland