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Breath Analysis in in Adults With Cystic Fibrosis (CF)

NCT ID: NCT02209571

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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Breath Tests

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cystic Fibrosis

Breath test and venous blood markers in cystic fibrosis patients

Group Type EXPERIMENTAL

Venous blood markers

Intervention Type OTHER

Routine venous blood sampling

Control

Breath test and venous blood markers in healthy subjects

Group Type ACTIVE_COMPARATOR

Venous blood markers

Intervention Type OTHER

Routine venous blood sampling

Interventions

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Venous blood markers

Routine venous blood sampling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm Kohler, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2014-0076

Identifier Type: -

Identifier Source: org_study_id