NCT05375149 Exhaled Breath Particles in Lung Transplantation
| NCT ID | NCT05375149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University Hospital |
| Condition | Lung Transplant Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-09-18 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2018-09-18 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients who have undergone LTx at Skåne University Hospital, SUS Lund Exclusion Criteria: * None
Contact & Investigator
Sandra Lindstedt, MD, PhD
PRINCIPAL INVESTIGATOR
Region Skåne, Lund University
Frequently Asked Questions
Who can join the NCT05375149 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 75 Years, studying Lung Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05375149 currently recruiting?
Yes, NCT05375149 is actively recruiting participants. Contact the research team at sandra.lindstedt_ingemansson@med.lu.se for enrollment information.
Where is the NCT05375149 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT05375149 clinical trial?
NCT05375149 is sponsored by Lund University Hospital. The principal investigator is Sandra Lindstedt, MD, PhD at Region Skåne, Lund University. The trial plans to enroll 150 participants.