Breath Analysis in in Adults With Cystic Fibrosis (CF)

N/ACompletedNCT02209571

University of Zurich60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Venous blood markersOTHER

Routine venous blood sampling

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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)

Time frame: up to 2 years

Secondary Outcomes

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)

Time frame: up to 2 years

Data from ClinicalTrials.gov

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