Lung Clearance Index and Lung Allograft Dysfunction

Lung Clearance Index for the Early Detection and Monitoring of Lung Allograft Dysfunction After Adult Lung Transplantation

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Transplantation; Chronic Lung Allograft Dysfunction; Rejection Lung Transplant
• Intervention / Treatment: Other: Early detection of CLAD by Lung Clearance Index (LCI)

Detailed Description

This single center study consists of three parts:

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

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)	Change from baseline up to 3 years
Change in forced expiratory volume in 1s (FEV1)	Measured by Spirometry (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in forced vital capacity (FVC)	Measured by Spirometry (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)	Measured by Spirometry (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in total lung capacity (TLC)	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in residual volume (RV)	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in total lung capacity (TLC) / residual volume (RV) ratio	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)	Change from baseline up to 3 years
Change in diffusing capacity for nitric oxide (DLNO)	Single-breath measurements (Jaeger MasterScreenTM PFT system)	Change from baseline up to 3 years
Change in diffusing capacity for carbon monoxide oxide (DLCO)	Single-breath measurements (Jaeger MasterScreenTM PFT system)	Change from baseline up to 3 years
Change in DLNO/DLCO ratio	Single-breath measurements (Jaeger MasterScreenTM PFT system)	Change from baseline up to 3 years
Change in transfer coefficient for nitric oxide (DLNO/VA)	Single-breath measurements (Jaeger MasterScreenTM PFT system)	Change from baseline up to 3 years
Change in transfer coefficient for carbon monoxide (DLCO/VA)	Single-breath measurements (Jaeger MasterScreenTM PFT system)	Change from baseline up to 3 years
Change in computed tomography score	Measured by Computed Tomography: Semiquantative score (i.e., Brody Score); Subscores including bronchiectasis, mucus plugging, airway wall thickening, consolidation, mosaic pattern and air trapping). Subscores will be expressed as the percentage of the maximum score on a scale of 0 (no disease) to 100 (maximal lung disease).	Change from baseline up to 3 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Christian Benden, Prof., MD, University Hospital of Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-02174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No