Skip to main content
OpenTrials
Completed

NCT Number: NCT02209571

Breath Analysis in in Adults With Cystic Fibrosis (CF)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous blood markers

Other

Routine venous blood sampling

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.