Lung Transplant RejectionNCT05375149
Exhaled Breath Particles in Lung Transplantation
An observational study of Lung Transplant Rejection and Primary Graft Dysfunction, run by Lund University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Lung Transplant Rejection, Primary Graft Dysfunction, Chronic Rejection of Lung Transplant
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 18 Sep 2018to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing lung transplantation at Skåne University Hospital, SUS Lund.
Who may be able to join
- Patients who have undergone LTx at Skåne University Hospital, SUS Lund
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Lund, Skåne County, 224 60
Sandra Lindstedt, MD, PhD, 0737220580, sandra.lindstedt_ingemansson@med.lu.se
About this study
Official title: Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation
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.
Read the detailed 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.
- Conditions
- Lung Transplant Rejection, Primary Graft Dysfunction, Chronic Rejection of Lung Transplant
- Keywords
- Exhaled Breath Particles, PExA, Lung transplantation, Primary Graft Dysfunction, Chronic Lug Allograft Dysfunction
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LTx rejection | Lung transplanted patients with acute or chronic rejection | |
| LTx non-rejection | Lung transplanted patients without any form of rejection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-transplantation
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.
Measured: Day 1-3 after lung transplantation
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.
Measured: 1 month after lung transplantation
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.
Measured: 3 months after lung transplantation
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.
Measured: 6 months after lung transplantation
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.
Measured: 9 months after lung transplantation
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.
Measured: 12 months after lung transplantation
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.
Measured: 18 months after lung transplantation
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.
Measured: 2 years after lung transplantation
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.
Measured: 3 years after lung transplantation
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.
Measured: 4 years after lung transplantation
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.
Measured: Day 1-3 after transplantation
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.
Measured: 1 month after transplantation
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.
Measured: 3 months after transplantation
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.
Measured: 6 months after transplantation
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.
Measured: 9 months after transplantation
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.
Measured: 12 months after transplantation
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.
Measured: 18 months after transplantation
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.
Measured: 2 years after transplantation
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.
Measured: 3 years after transplantation
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.
Measured: 4 years after transplantation
Secondary outcomes (33)
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: Pre-transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: Day 1 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: Day 2 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: Day 3 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 1 month after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 3 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 6 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 9 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 12 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 18 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 2 years after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 3 years after lung transplantation
Concentration of proteins and other biomarkers in plasma
Concentration and composition of proteins and other biomarkers will be analysed in plasma
Measured: 4 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: Day 1-3 after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 1 month after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 3 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 6 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 9 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 12 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 18 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 2 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 3 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Concentration and composition of proteins and other biomarkers will be analysed in BAL
Measured: 4 years after lung transplantation
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.
Measured: At the time of lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 1 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 3 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 6 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 9 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 12 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 18 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 2 years after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 3 years after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Concentration and composition of proteins and other biomarkers will be analysed in lung tissue
Measured: 4 years after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start18 Sep 2018
- Primary completionSep 2024 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Lindstedt, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375149
- Sponsor's protocol ID
- LTxPEx
- Status last verified
- Feb 2022
- First submitted
- 10 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1097/TXD.0000000000000615. eCollection 2016 Sep.
PubMed 27795995Stenlo M, Hyllen S, Silva IAN, Bolukbas 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.
PubMed 31994907Broberg E, Hyllen 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.
PubMed 31615381Behndig 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.
PubMed 31558154
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Particles as a Clinical Indicator for Acute and Chronic Rejection After Lung Transplantation
- ClinicalTrials.gov ID
- NCT05375149
- Acronym / sponsor ID
- LTxPEx
- Conditions
- Lung Transplant Rejection, Primary Graft Dysfunction, Chronic Rejection of Lung Transplant
- Keywords
- Exhaled Breath Particles, PExA, Lung transplantation, Primary Graft Dysfunction, Chronic Lug Allograft Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTx rejection | – | –Lung transplanted patients with acute or chronic rejection |
| LTx non-rejection | – | –Lung transplanted patients without any form of rejection |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing lung transplantation at Skåne University Hospital, SUS Lund.
Key inclusion criteria (1 listed)
- Patients who have undergone LTx at Skåne University Hospital, SUS Lund
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of proteins in EBP
Time frame: Pre-transplantation
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.
Concentration of proteins in EBP
Time frame: Day 1-3 after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 1 month after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 3 months after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 6 months after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 9 months after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 12 months after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 18 months after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 2 years after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 3 years after lung transplantation
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.
Concentration of proteins in EBP
Time frame: 4 years after lung transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: Day 1-3 after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 1 month after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 3 months after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 6 months after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 9 months after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 12 months after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 18 months after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 2 years after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 3 years after transplantation
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.
Particle flow rate from the airways (PFR)
Time frame: 4 years after transplantation
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.
33 secondary outcomes
Concentration of proteins and other biomarkers in plasma
Time frame: Pre-transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: Day 1 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: Day 2 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: Day 3 after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 1 month after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 3 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 6 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 9 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 12 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 18 months after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 2 years after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 3 years after lung transplantation
Concentration of proteins and other biomarkers in plasma
Time frame: 4 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: Day 1-3 after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 1 month after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 3 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 6 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 9 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 12 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 18 months after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 2 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 3 years after lung transplantation
Concentration of proteins and other biomarkers in BAL
Time frame: 4 years after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: At the time of lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 1 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 3 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 6 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 9 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 12 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 18 months after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 2 years after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 3 years after lung transplantation
Concentration of proteins and other biomarkers in lung tissue
Time frame: 4 years after lung transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 27795995Ericson 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. doi: 10.1097/TXD.0000000000000615. eCollection 2016 Sep.
- Background: PubMed 31994907Stenlo M, Hyllen S, Silva IAN, Bolukbas 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.
- Background: PubMed 31615381Broberg E, Hyllen 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.
- Background: PubMed 31558154Behndig 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.
- Individual participant dataSharing planned: No
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Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lindstedt, MD, PhD principal investigator
Region Skåne, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Rejection and Primary Graft Dysfunction, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Lindstedt, MD, PhD (+46737220580, sandra.lindstedt_ingemansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of proteins in EBP (time frame: Pre-transplantation). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375149, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.