Breath Analysis in in Adults With Cystic Fibrosis (CF)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02209571

Enrollment

Registered

2014-08-06

Start date

2014-10-31

Completion date

2015-12-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Breath Tests

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.

Interventions

OTHERVenous blood markers

Routine venous blood sampling

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026