Chronic Rejection of Lung TransplantNCT05586906
Noninvasive Early Detection of Lung Allograft Dysfunction After Lung Transplantation With Multiple Breath Washout Test
A study testing Multiple Breath Washout (MBW) tests in people with Chronic Rejection of Lung Transplant, run by University of Zurich at 1 site in Switzerland.
Trial summary
Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation. The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rejection of Lung Transplant
- What is being tested?
- Multiple Breath Washout (MBW) tests
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All recipients who underwent bilateral lung transplantation at Zurich University Hospital will be included.
Who cannot join
- Retransplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Carolin Steinack, MD, 0041442551111, carolin.steinack@usz.ch
About this study
Official title: Noninvasive Early Detection of Lung Allograft Dysfunction After Lung Transplantation With Multiple Breath Washout Test: Lung Clearance Index as an Early Marker
Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation. The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Early detection would be desirable since it allows treatment modification to stop or delay the process. In the last few years there has been a growing interest in lung clearance index (LCI), a measure of lung physiology derived from multiple breath washout tests. LCI is derived from Multiple Breath Washout (MBW) tests. Early detection of BOS with LCI measurement will allow the investigators early recognition of this chronic rejection form and with early institution of the enhanced treatment survival will increase. All paticipants who underwent bilateral lung transplantation at Zurich University Hospital will be included. The measurement will be done 3 months after lung transplantation. Approximately 90 paticipants will be included. The follow-up will be 5 years. If the investigators could detect the development of BOS with this novel method before the clinical deterioration (fall in lung function) the investigators can start the available treatment options before irreversible damage occurs. This might increase overall survival in the study cohort.
Read the detailed description
Lung transplantation is a treatment option for patients with advanced lung disease or irreversible pulmonary failure. Despite advancements in surgical techniques, lung preservation, immunosuppression, and management of ischemia/reperfusion injury and infections, chronic allograft rejection continue to be a major problem. Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation.
BOS affects 50% or more of recipients who survive beyond 5 years and accounts for a considerable proportion of cases of lung allograft loss and recipient death beyond 3 months post-transplant. It is the leading cause of death for recipients who survive beyond 1 year post-transplant, and it is widely perceived as the physiological surrogate of immunologically-mediated phenomena due to many observations that include its association with acute cellular rejection, the tendency of recipients who develop BOS to have greater degrees of human leukocyte antigen mismatch, and accumulating evidence of the involvement of autoimmune pathways. Furthermore, there are striking similarities to obliterative bronchiolitis that can occur in allogeneic bone marrow or stem cell transplant recipients as well as in patients with connective tissue diseases, which are also perceived as alloimmune or autoimmune disorders, respectively. Therefore, BOS is frequently equated with the term chronic rejection.
The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Early detection would be desirable since it allows treatment modification to stop or delay the process. Due to the sporadic or patchy involvement of obliterative bronchiolitis, pathologic diagnosis can be missed by transbronchial biopsies (TBB), which are often performed to exclude other diagnoses including acute rejection or infection. Histologically, early lesions of BOS demonstrate partial or complete obstruction of the small airways.
Currently, radiographic imaging is not used as a diagnostic tool in transplant recipients when evaluating for BOS; however, high resolution computed tomography (HRCT) imaging with inspiratory and expiratory views may be helpful when considering the diagnosis.
In the last few years there has been a growing interest in lung clearance index (LCI), a measure of lung physiology derived from multiple breath washout tests. LCI is derived from Multiple Breath Washout (MBW) tests. The test involves following the washout of an inert tracer gas from the lungs during relaxed tidal breathing. The tracer gas can be nitrogen that is normally resident in the lungs, washed out when the participant is switched to breathing 100% oxygen.
This test (lung clearing index) detects early airways disease in children, and is more sensitive and easier to perform in this population than conventional lung function tests. With an appreciation of the importance of earlier identification of airways dysfunction, and prevention of irreversible structural airway changes, methods of following airways disease in these ''silent years'' are especially important. LCI has now been reported in studies involving all age groups, from infants to adults, and has a narrow range of normal over this wide age range, making it especially suitable for long-term follow-up studies.
Specific Aim:
Early detection of development BOS with LCI before deterioration in the conventional lung function test occurs.
Hypothesis:
Early detection of BOS with LCI measurement will allow the investigators early recognition of this chronic rejection form and with early institution of the enhanced treatment survival will increase.
Study population:
All participants who underwent bilateral lung transplantation at Zurich University Hospital will be included. The measurement will be done 3 months after lung transplantation. Approximately 90 patients will be included. The follow-up will be 5 years.
Method:
LCI measurements (EXHALYZER® D with Nitrogen Washout System, ECO Medics AG) will be performed every month during follow-up beginning 3 months after lung transplantation. The test will be repeated every month. Follow-up will be 5 years. Individually the follow-up period might be prolonged.
Relevance and impact:
If the investigators could detect the development of BOS with this novel method before the clinical deterioration (fall in lung function) the investigators can start the available treatment options before irreversible damage occurs. This might increase overall survival in study cohort.
- Conditions
- Chronic Rejection of Lung Transplant
- Being tested
- Multiple Breath Washout (MBW) tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Breath Washout (MBW) testsDevice
LCI measurements (EXHALYZER® D with Nitrogen Washout System, ECO Medics AG) will be performed every month during follow-up beginning 3 months after lung transplantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index (LCI) derived from Multiple Breath Washout Test (MBWT)
LCI 2.5 (ext): lung clearance index at normalised end tidal concentration of N2 2.5% extrapolated
Measured: 5 years
FEV1 (L)
Forced expiratory volume in one second measured in liters
Measured: 5 years
FEV1 (%)
percent of forced expiratory volume in one second measured in percent
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Mar 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rejection of Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilhan Inci, University of Zurich
- Investigators
- Carolin Steinack, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586906
- Sponsor's protocol ID
- 2017-01610
- Other IDs
- 2017
- Status last verified
- May 2023
- First submitted
- 2 Nov 2017
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Early Detection of Lung Allograft Dysfunction After Lung Transplantation With Multiple Breath Washout Test: Lung Clearance Index as an Early Marker
- ClinicalTrials.gov ID
- NCT05586906
- Acronym / sponsor ID
- 2017-01610
- Conditions
- Chronic Rejection of Lung Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Oct 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.
Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation. The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Early detection would be desirable since it allows treatment modification to stop or delay the process. In the last few years there has been a growing interest in lung clearance index (LCI), a measure of lung physiology derived from multiple breath washout tests. LCI is derived from Multiple Breath Washout (MBW) tests. Early detection of BOS with LCI measurement will allow the investigators early recognition of this chronic rejection form and with early institution of the enhanced treatment survival will increase. All paticipants who underwent bilateral lung transplantation at Zurich University Hospital will be included. The measurement will be done 3 months after lung transplantation. Approximately 90 paticipants will be included. The follow-up will be 5 years. If the investigators could detect the development of BOS with this novel method before the clinical deterioration (fall in lung function) the investigators can start the available treatment options before irreversible damage occurs. This might increase overall survival in the study cohort.
Detailed description
Lung transplantation is a treatment option for patients with advanced lung disease or irreversible pulmonary failure. Despite advancements in surgical techniques, lung preservation, immunosuppression, and management of ischemia/reperfusion injury and infections, chronic allograft rejection continue to be a major problem. Chronic rejection, more commonly called bronchiolitis obliterans syndrome (BOS), is the leading cause of death beyond the first year post lung transplantation.
BOS affects 50% or more of recipients who survive beyond 5 years and accounts for a considerable proportion of cases of lung allograft loss and recipient death beyond 3 months post-transplant. It is the leading cause of death for recipients who survive beyond 1 year post-transplant, and it is widely perceived as the physiological surrogate of immunologically-mediated phenomena due to many observations that include its association with acute cellular rejection, the tendency of recipients who develop BOS to have greater degrees of human leukocyte antigen mismatch, and accumulating evidence of the involvement of autoimmune pathways. Furthermore, there are striking similarities to obliterative bronchiolitis that can occur in allogeneic bone marrow or stem cell transplant recipients as well as in patients with connective tissue diseases, which are also perceived as alloimmune or autoimmune disorders, respectively. Therefore, BOS is frequently equated with the term chronic rejection.
The diagnosis of BOS is typically made by clinical, physiological, and radiographic parameters. Early detection would be desirable since it allows treatment modification to stop or delay the process. Due to the sporadic or patchy involvement of obliterative bronchiolitis, pathologic diagnosis can be missed by transbronchial biopsies (TBB), which are often performed to exclude other diagnoses including acute rejection or infection. Histologically, early lesions of BOS demonstrate partial or complete obstruction of the small airways.
Currently, radiographic imaging is not used as a diagnostic tool in transplant recipients when evaluating for BOS; however, high resolution computed tomography (HRCT) imaging with inspiratory and expiratory views may be helpful when considering the diagnosis.
In the last few years there has been a growing interest in lung clearance index (LCI), a measure of lung physiology derived from multiple breath washout tests. LCI is derived from Multiple Breath Washout (MBW) tests. The test involves following the washout of an inert tracer gas from the lungs during relaxed tidal breathing. The tracer gas can be nitrogen that is normally resident in the lungs, washed out when the participant is switched to breathing 100% oxygen.
This test (lung clearing index) detects early airways disease in children, and is more sensitive and easier to perform in this population than conventional lung function tests. With an appreciation of the importance of earlier identification of airways dysfunction, and prevention of irreversible structural airway changes, methods of following airways disease in these ''silent years'' are especially important. LCI has now been reported in studies involving all age groups, from infants to adults, and has a narrow range of normal over this wide age range, making it especially suitable for long-term follow-up studies.
Specific Aim:
Early detection of development BOS with LCI before deterioration in the conventional lung function test occurs.
Hypothesis:
Early detection of BOS with LCI measurement will allow the investigators early recognition of this chronic rejection form and with early institution of the enhanced treatment survival will increase.
Study population:
All participants who underwent bilateral lung transplantation at Zurich University Hospital will be included. The measurement will be done 3 months after lung transplantation. Approximately 90 patients will be included. The follow-up will be 5 years.
Method:
LCI measurements (EXHALYZER® D with Nitrogen Washout System, ECO Medics AG) will be performed every month during follow-up beginning 3 months after lung transplantation. The test will be repeated every month. Follow-up will be 5 years. Individually the follow-up period might be prolonged.
Relevance and impact:
If the investigators could detect the development of BOS with this novel method before the clinical deterioration (fall in lung function) the investigators can start the available treatment options before irreversible damage occurs. This might increase overall survival in study cohort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All recipients who underwent bilateral lung transplantation at Zurich University Hospital will be included.
Key exclusion criteria (1 listed)
- Retransplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Breath Washout (MBW) testsLCI measurements (EXHALYZER® D with Nitrogen Washout System, ECO Medics AG) will be performed every month during follow-up beginning 3 months after lung transplantation. | Device | – |
Primary outcome
Lung Clearance Index (LCI) derived from Multiple Breath Washout Test (MBWT)
Time frame: 5 years
LCI 2.5 (ext): lung clearance index at normalised end tidal concentration of N2 2.5% extrapolated
FEV1 (L)
Time frame: 5 years
Forced expiratory volume in one second measured in liters
FEV1 (%)
Time frame: 5 years
percent of forced expiratory volume in one second measured in percent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Carolin Steinack, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Breath Washout (MBW) tests in people with Chronic Rejection of Lung Transplant, run by University of Zurich at 1 site in Switzerland.
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: looking for participants now, as of the sponsor's last update on 16 May 2023. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolin Steinack, MD (0041442551111, carolin.steinack@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Clearance Index (LCI) derived from Multiple Breath Washout Test (MBWT) (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2023.