Lung Clearance Index and Lung Allograft Dysfunction | NCT03850002

Studies
Lung Clearance Index and Lung Allograft Dysfunction

NCT03850002

Sponsor

University of Zurich

Status

Withdrawn

Last Update Posted

Jul 25, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Transplantation
Chronic Lung Allograft Dysfunction
Rejection Lung Transplant

Interventions

Early detection of CLAD by Lung Clearance Index (LCI)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI leaving institution

Expanded Access Info

Start Date

Mar 1, 2019Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Feb 14, 2019

First Submission Date that Met QC Criteria

Feb 19, 2019

First Posted Date

Feb 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2019

Last Update Posted Date

Jul 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.

Detailed Description

This single center study consists of three parts:

Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)
Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)
Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early detection of CLAD by Lung Clearance Index (LCI)	Other	Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in lung clearance index (LCI)	Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)	Change from baseline up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Change in slope of acinar airways (Sacin)	Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)	Change from baseline up to 3 years
Change in slope of conducting airways (Scond)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female lung transplant recipients
Written informed consent by the participant after information about the research project

Exclusion Criteria:

Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)
Acute airway infection
Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult lung transplant patients from University Hospital Zurich will be invited to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Benden, Prof., MD	University Hospital of Zurich, Zurich, Switzerland	Principal Investigator

Locations

Not provided