NCT03850002

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Status
withdrawn

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

February 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

February 14, 2019

Last Update Submit

July 24, 2019

Conditions

Lung TransplantationChronic Lung Allograft DysfunctionRejection Lung Transplant

Outcome Measures

Primary Outcomes (1)

  • 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 (14)

  • Change in slope of acinar airways (Sacin)

    Change from baseline up to 3 years

  • Change in slope of conducting airways (Scond)

    Change from baseline up to 3 years

  • Change in forced expiratory volume in 1s (FEV1)

    Change from baseline up to 3 years

  • Change in forced vital capacity (FVC)

    Change from baseline up to 3 years

  • Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)

    Change from baseline up to 3 years

  • +9 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Christian Benden, Prof., MD

    University Hospital of Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 21, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2022

Study Completion

September 30, 2023

Last Updated

July 25, 2019

Record last verified: 2019-07