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Breath Analysis in in Adults With Cystic Fibrosis (CF)

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ClinicalTrials.gov Identifier: NCT02209571
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Venous blood markers Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Cystic Fibrosis
Breath test and venous blood markers in cystic fibrosis patients
Other: Venous blood markers
Routine venous blood sampling

Active Comparator: Control
Breath test and venous blood markers in healthy subjects
Other: Venous blood markers
Routine venous blood sampling




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209571


Locations
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Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Malcolm Kohler, MD, Prof University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02209571     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0076
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by University of Zurich:
Breath Tests
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases