NCT02209571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

July 18, 2014

Last Update Submit

December 10, 2015

Conditions

Cystic Fibrosis

Keywords

Breath Tests

Outcome Measures

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)

    up to 2 years

Secondary Outcomes (1)

  • Composite of clinical records

    up to 2 years

Study Arms (2)

Cystic Fibrosis

EXPERIMENTAL

Breath test and venous blood markers in cystic fibrosis patients

Other: Venous blood markers

Control

ACTIVE COMPARATOR

Breath test and venous blood markers in healthy subjects

Other: Venous blood markers

Interventions

Venous blood markersOTHER

Routine venous blood sampling

ControlCystic Fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Malcolm Kohler, MD, Prof

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

August 6, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

CH(1)