Breath Analysis in in Adults With Cystic Fibrosis (CF)
Overview
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.
Full Title of Study: “Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
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.
Interventions
- Other: Venous blood markers
- Routine venous blood sampling
Arms, Groups and Cohorts
- Experimental: Cystic Fibrosis
- Breath test and venous blood markers in cystic fibrosis patients
- Active Comparator: Control
- Breath test and venous blood markers in healthy subjects
Clinical Trial Outcome Measures
Primary Measures
- Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
- Time Frame: up to 2 years
- Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
Secondary Measures
- Composite of clinical records
- Time Frame: 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)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Zurich
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Malcolm Kohler, MD, Prof, Principal Investigator, University of Zurich
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