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CompletedNCT02209571Updated Dec 11, 2015

Breath Analysis in in Adults With Cystic Fibrosis (CF)

An interventional study of Venous blood markers in Cystic Fibrosis, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-11.

Sponsored by University of Zurich · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cystic Fibrosis

Keywords

  • Breath Tests
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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's planned enrollment of 60 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Clinical diagnosis of cystic fibrosis (for CF-patients)
  • Age ≥ 18 years

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Cystic Fibrosis

    Breath test and venous blood markers in cystic fibrosis patients

    Other: Venous blood markers

  • Active comparator
    Control

    Breath test and venous blood markers in healthy subjects

    Other: Venous blood markers

Interventions

  • OtherVenous blood markers

    Routine venous blood sampling

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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

1 site
  • University Hospital Zurich, Pulmonary Division
    Zurich, 8091, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02209571
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Aug 6, 2014
Start date
Oct 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Dec 11, 2015

Study contacts

Malcolm Kohler, MD, Prof
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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