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NCT03850002 Clinical Trial

Lung Clearance Index and Lung Allograft Dysfunction

Lung Transplantation Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03850002
Other study ID # 2018-02174
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date September 30, 2023

Study information
Verified date July 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Early detection of CLAD by Lung Clearance Index (LCI)
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Change in forced expiratory volume in 1s (FEV1) Measured by Spirometry (Geratherm Respiratory GmbH) Change from baseline up to 3 years
Secondary Change in forced vital capacity (FVC) Measured by Spirometry (Geratherm Respiratory GmbH) Change from baseline up to 3 years
Secondary 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
Secondary Change in total lung capacity (TLC) Measured by Bodyplethysmography (Geratherm Respiratory GmbH) Change from baseline up to 3 years
Secondary Change in residual volume (RV) Measured by Bodyplethysmography (Geratherm Respiratory GmbH) Change from baseline up to 3 years
Secondary Change in total lung capacity (TLC) / residual volume (RV) ratio Measured by Bodyplethysmography (Geratherm Respiratory GmbH) Change from baseline up to 3 years
Secondary Change in diffusing capacity for nitric oxide (DLNO) Single-breath measurements (Jaeger MasterScreenTM PFT system) Change from baseline up to 3 years
Secondary Change in diffusing capacity for carbon monoxide oxide (DLCO) Single-breath measurements (Jaeger MasterScreenTM PFT system) Change from baseline up to 3 years
Secondary Change in DLNO/DLCO ratio Single-breath measurements (Jaeger MasterScreenTM PFT system) Change from baseline up to 3 years
Secondary Change in transfer coefficient for nitric oxide (DLNO/VA) Single-breath measurements (Jaeger MasterScreenTM PFT system) Change from baseline up to 3 years
Secondary Change in transfer coefficient for carbon monoxide (DLCO/VA) Single-breath measurements (Jaeger MasterScreenTM PFT system) Change from baseline up to 3 years
Secondary 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
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