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NCT05375149 Clinical Trial

Exhaled Breath Particles in Lung Transplantation

Lung Transplant Rejection Clinical Trial

Official title:
Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05375149
Other study ID # LTxPEx
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2018
Est. completion date September 2026

Study information
Verified date February 2022
Source Lund University Hospital
Contact Sandra Lindstedt, MD, PhD
Phone +46737220580
Email sandra.lindstedt_ingemansson@med.lu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lung transplantation (LTx) is the only effective treatment for patients with end stage lung disease. Of the major organs transplanted, survival following LTx is the lowest with a mean of 5 years. Despite improvements, primary graft dysfunction (PGD) remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) that remains the leading cause of late mortality. Earlier detection of rejection after LTx is of substantial importance as it would improve the possibilities of treatment and could increase survival. The investigators have shown in previous work that exhaled breath particles (EBP) reflect the composition of respiratory tract lining fluid (RTLF). EBP and particle flow rate (PFR) can be used as non-invasive methods for early detection and monitoring of airway diseases such as acute respiratory distress syndrome (ARDS). It has also been shown that the particle flow prolife after lung transplantation differs between patients who develop PGD and those who do not and that the composition of EBP differs between patients with and without bronchiolitis obliterans syndrome (BOS), an obstructive form of CLAD. Samples of EBP and measurements of PFR will be collected from lung transplanted patients. Membranes with EBP will be saved for molecular analysis. The investigators aim to identify potential particle flow patterns and biomarkers for earlier detection of rejection after lung transplantation.

Description:

Samples of EBP and measurement of PFR will be done on patients undergoing lung transplantation at Skåne University Hospital (SUS) Lund. Measurements of EBP and PFR and collection of blood will be done repeatedly postoperatively when the patient is still in the hospital, at three months post-transplantation, at six months post-transplantation, at 12 months post-transplantation and annually after that. An additional preoperative blood sample will also be obtained. Furthermore, the investigators will collect bronchoalveolar lavage fluid (BALF) and lung biopsies when the patient is scheduled for routine bronchoscopies in the follow-up period. This study involves measurements of EBP and PFR done by the particles in exhaled air (PExA) system on lung transplanted patients with and without acute or chronic rejection. The patients who do not develop any form of rejection will serve as a control group to the ones who develop rejection. Furthermore, each patient will serve as their own control. The purpose of this study is to find better means of identifying rejection of transplanted lungs in earlier stages, and to explore candidate biomarkers. Earlier diagnosis of rejection of the transplanted organ can lead to better treatment possibilities and a positive impact on survival after LTx.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date September 2026
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria: - Patients who have undergone LTx at Skåne University Hospital, SUS Lund Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Skåne University Hospital Lund Skåne Län

Sponsors (1)
Lead Sponsor Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Behndig AF, Mirgorodskaya E, Blomberg A, Olin AC. Surfactant Protein A in particles in exhaled air (PExA), bronchial lavage and bronchial wash - a methodological comparison. Respir Res. 2019 Sep 26;20(1):214. doi: 10.1186/s12931-019-1172-1. — View Citation

Broberg E, Hyllén S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11. — View Citation

Ericson PA, Mirgorodskaya E, Hammar OS, Viklund EA, Almstrand AR, Larsson PJ, Riise GC, Olin AC. Low Levels of Exhaled Surfactant Protein A Associated With BOS After Lung Transplantation. Transplant Direct. 2016 Aug 26;2(9):e103. eCollection 2016 Sep. — View Citation

Stenlo M, Hyllén S, Silva IAN, Bölükbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. Pre-transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. Day 1-3 after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 1 month after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 3 months after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 6 months after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 9 months after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 12 months after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 18 months after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 2 years after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 3 years after lung transplantation
Primary Concentration of proteins in EBP Proteins from exhaled air are collected onto a membrane for subsequently molecular analysis. Analysis aims to identify candidate biomarker for acute and chronic rejection of transplanted lungs. 4 years after lung transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. Day 1-3 after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 1 month after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 3 months after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 6 months after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 9 months after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 12 months after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 18 months after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 2 years after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 3 years after transplantation
Primary Particle flow rate from the airways (PFR) PFR will be measured by the PExA device. The flow rate and the particle pattern will be analysed to find differences between groups of lung transplanted patients with and without rejection. 4 years after transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma Pre-transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma Day 1 after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma Day 2 after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma Day 3 after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 1 month after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 3 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 6 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 9 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 12 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 18 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 2 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 3 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in plasma Concentration and composition of proteins and other biomarkers will be analysed in plasma 4 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL Day 1-3 after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 1 month after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 3 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 6 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 9 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 12 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 18 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 2 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 3 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in BAL Concentration and composition of proteins and other biomarkers will be analysed in BAL 4 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue. Both taken from the native lung and from the donor lung. At the time of lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 1 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 3 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 6 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 9 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 12 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 18 months after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 2 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 3 years after lung transplantation
Secondary Concentration of proteins and other biomarkers in lung tissue Concentration and composition of proteins and other biomarkers will be analysed in lung tissue 4 years after lung transplantation
See also
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Withdrawn NCT03805178 - Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization Phase 2
Completed NCT03359863 - Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction Phase 2
Active, not recruiting NCT03656926 - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) Phase 3
Completed NCT01985412 - Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection
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Recruiting NCT04837339 - Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation N/A
Recruiting NCT03090581 - Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation. N/A
Recruiting NCT06112951 - A Prospective Randomized Trial of ECP in Subclinical AMR N/A