Lung Clearance Index and Lung Allograft Dysfunction

Withdrawn

• Conditions: Chronic Lung Allograft Dysfunction; Rejection Lung Transplant; Lung Transplantation

• Registration Number: NCT03850002
• Lead Sponsor: University of Zurich

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:

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 Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-03-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25
• Primary Completion: 2022-12-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in slope of acinar airways (Sacin)	Change from baseline up to 3 years	Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Change in residual volume (RV)	Change from baseline up to 3 years	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Change in slope of conducting airways (Scond)	Change from baseline up to 3 years	Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)	Change from baseline up to 3 years	Measured by Spirometry (Geratherm Respiratory GmbH)
Change in total lung capacity (TLC) / residual volume (RV) ratio	Change from baseline up to 3 years	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Change in transfer coefficient for nitric oxide (DLNO/VA)	Change from baseline up to 3 years	Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change in total lung capacity (TLC)	Change from baseline up to 3 years	Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Change in diffusing capacity for nitric oxide (DLNO)	Change from baseline up to 3 years	Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change in DLNO/DLCO ratio	Change from baseline up to 3 years	Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change in forced expiratory volume in 1s (FEV1)	Change from baseline up to 3 years	Measured by Spirometry (Geratherm Respiratory GmbH)
Change in forced vital capacity (FVC)	Change from baseline up to 3 years	Measured by Spirometry (Geratherm Respiratory GmbH)
Change in transfer coefficient for carbon monoxide (DLCO/VA)	Change from baseline up to 3 years	Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change in diffusing capacity for carbon monoxide oxide (DLCO)	Change from baseline up to 3 years	Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change in computed tomography score	Change from baseline up to 3 years	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).