Clinical trial NCT03850002: Lung Clearance Index and Lung Allograft Dysfunction
Official title: Lung Clearance Index for the Early Detection and Monitoring of Lung Allograft Dysfunction After Adult Lung Transplantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Transplantation
Chronic Lung Allograft Dysfunction
Rejection Lung Transplant
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult lung transplant patients from University Hospital Zurich will be invited to participate.

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)

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

Primary outcomes:
measure: Change in lung clearance index (LCI)
timeFrame: Change from baseline up to 3 years
Secondary outcomes:
measure: Change in slope of acinar airways (Sacin)
timeFrame: Change from baseline up to 3 years
measure: Change in slope of conducting airways (Scond)
timeFrame: Change from baseline up to 3 years
measure: Change in forced expiratory volume in 1s (FEV1)
timeFrame: Change from baseline up to 3 years
measure: Change in forced vital capacity (FVC)
timeFrame: Change from baseline up to 3 years
measure: Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)
timeFrame: Change from baseline up to 3 years
measure: Change in total lung capacity (TLC)
timeFrame: Change from baseline up to 3 years
measure: Change in residual volume (RV)
timeFrame: Change from baseline up to 3 years
measure: Change in total lung capacity (TLC) / residual volume (RV) ratio
timeFrame: Change from baseline up to 3 years
measure: Change in diffusing capacity for nitric oxide (DLNO)
timeFrame: Change from baseline up to 3 years
measure: Change in diffusing capacity for carbon monoxide oxide (DLCO)
timeFrame: Change from baseline up to 3 years
measure: Change in DLNO/DLCO ratio
timeFrame: Change from baseline up to 3 years
measure: Change in transfer coefficient for nitric oxide (DLNO/VA)
timeFrame: Change from baseline up to 3 years
measure: Change in transfer coefficient for carbon monoxide (DLCO/VA)
timeFrame: Change from baseline up to 3 years
measure: Change in computed tomography score
timeFrame: Change from baseline up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Zurich, Zurich, Switzerland
name: Christian Benden, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: