ClinicalTrials.gg
Sign In
RecruitingNCT05375149Updated May 16, 2022

Exhaled Breath Particles in Lung Transplantation

An observational study in Lung Transplant Rejection, Primary Graft Dysfunction and Chronic Rejection of Lung Transplant, sponsored by Lund University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Lund University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2018; still recruiting 8 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Primary Graft Dysfunction

26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.

Browse Primary Graft Dysfunction studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing lung transplantation at Skåne University Hospital, SUS Lund.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have undergone LTx at Skåne University Hospital, SUS Lund

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • LTx rejection

    Lung transplanted patients with acute or chronic rejection

  • LTx non-rejection

    Lung transplanted patients without any form of rejection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-transplantation

  2. 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.

    Time frame: Day 1-3 after lung transplantation

  3. 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.

    Time frame: 1 month after lung transplantation

  4. 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.

    Time frame: 3 months after lung transplantation

  5. 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.

    Time frame: 6 months after lung transplantation

  6. 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.

    Time frame: 9 months after lung transplantation

  7. 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.

    Time frame: 12 months after lung transplantation

  8. 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.

    Time frame: 18 months after lung transplantation

  9. 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.

    Time frame: 2 years after lung transplantation

  10. 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.

    Time frame: 3 years after lung transplantation

  11. 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.

    Time frame: 4 years after lung transplantation

  12. 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.

    Time frame: Day 1-3 after transplantation

  13. 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.

    Time frame: 1 month after transplantation

  14. 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.

    Time frame: 3 months after transplantation

  15. 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.

    Time frame: 6 months after transplantation

  16. 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.

    Time frame: 9 months after transplantation

  17. 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.

    Time frame: 12 months after transplantation

  18. 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.

    Time frame: 18 months after transplantation

  19. 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.

    Time frame: 2 years after transplantation

  20. 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.

    Time frame: 3 years after transplantation

  21. 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.

    Time frame: 4 years after transplantation

Secondary outcomes

  1. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: Pre-transplantation

  2. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: Day 1 after lung transplantation

  3. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: Day 2 after lung transplantation

  4. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: Day 3 after lung transplantation

  5. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 1 month after lung transplantation

  6. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 3 months after lung transplantation

  7. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 6 months after lung transplantation

  8. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 9 months after lung transplantation

  9. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 12 months after lung transplantation

  10. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 18 months after lung transplantation

  11. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 2 years after lung transplantation

  12. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 3 years after lung transplantation

  13. Concentration of proteins and other biomarkers in plasma

    Concentration and composition of proteins and other biomarkers will be analysed in plasma

    Time frame: 4 years after lung transplantation

  14. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: Day 1-3 after lung transplantation

  15. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 1 month after lung transplantation

  16. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 3 months after lung transplantation

  17. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 6 months after lung transplantation

  18. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 9 months after lung transplantation

  19. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 12 months after lung transplantation

  20. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 18 months after lung transplantation

  21. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 2 years after lung transplantation

  22. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 3 years after lung transplantation

  23. Concentration of proteins and other biomarkers in BAL

    Concentration and composition of proteins and other biomarkers will be analysed in BAL

    Time frame: 4 years after lung transplantation

  24. 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.

    Time frame: At the time of lung transplantation

  25. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 1 months after lung transplantation

  26. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 3 months after lung transplantation

  27. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 6 months after lung transplantation

  28. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 9 months after lung transplantation

  29. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 12 months after lung transplantation

  30. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 18 months after lung transplantation

  31. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 2 years after lung transplantation

  32. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 3 years after lung transplantation

  33. Concentration of proteins and other biomarkers in lung tissue

    Concentration and composition of proteins and other biomarkers will be analysed in lung tissue

    Time frame: 4 years after lung transplantation

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 27795995 ↗
  • Stenlo 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 31994907 ↗
  • Broberg 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 31615381 ↗
  • 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. PubMed 31558154 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2018 (actual). Primary completion is estimated for Sep 2024, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2022
First posted
May 16, 2022
StartActual
Sep 18, 2018
Primary completionEst.
Sep 2024
CompletionEst.
Sep 2026
Last update
May 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05375149
Lead sponsor
Lund University Hospital
Responsible party
Sponsor
First posted
May 16, 2022
Start date
Sep 18, 2018
Primary completion
Sep 2024 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 16, 2022

Study contacts

Sandra Lindstedt, MD, PhD
Contact
sandra.lindstedt_ingemansson@med.lu.se
+46737220580
Sandra Lindstedt, MD, PhD
principal investigator · Region Skåne, Lund University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Primary Graft Dysfunction →

Other studies from this sponsor

Lund University Hospital

Start the discussion