Lung TransplantationNCT03850002
Lung Clearance Index and Lung Allograft Dysfunction
An observational study of Lung Transplantation and Chronic Lung Allograft Dysfunction, run by University of Zurich.
Trial summary
The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Chronic Lung Allograft Dysfunction, Rejection Lung Transplant
- What is being tested?
- Early detection of CLAD by Lung Clearance Index (LCI)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult lung transplant patients from University Hospital Zurich will be invited to participate.
Who may be able to join
- Male and female lung transplant recipients
- Written informed consent by the participant after information about the research project
Who cannot join
- Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)
- Acute airway infection
- Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM
About this study
Official title: Lung Clearance Index for the Early Detection and Monitoring of Lung Allograft Dysfunction After Adult Lung Transplantation
The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.
Read the detailed description
This single center study consists of three parts:
- Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)
- Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)
- Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)
- Being tested
- Early detection of CLAD by Lung Clearance Index (LCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early detection of CLAD by Lung Clearance Index (LCI)Other
Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung clearance index (LCI)
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Measured: Change from baseline up to 3 years
Secondary outcomes (14)
Change in slope of acinar airways (Sacin)
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Measured: Change from baseline up to 3 years
Change in slope of conducting airways (Scond)
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Measured: Change from baseline up to 3 years
Change in forced expiratory volume in 1s (FEV1)
Measured by Spirometry (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in forced vital capacity (FVC)
Measured by Spirometry (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)
Measured by Spirometry (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in total lung capacity (TLC)
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in residual volume (RV)
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in total lung capacity (TLC) / residual volume (RV) ratio
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Measured: Change from baseline up to 3 years
Change in diffusing capacity for nitric oxide (DLNO)
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Measured: Change from baseline up to 3 years
Change in diffusing capacity for carbon monoxide oxide (DLCO)
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Measured: Change from baseline up to 3 years
Change in DLNO/DLCO ratio
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Measured: Change from baseline up to 3 years
Change in transfer coefficient for nitric oxide (DLNO/VA)
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Measured: Change from baseline up to 3 years
Change in transfer coefficient for carbon monoxide (DLCO/VA)
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Measured: Change from baseline up to 3 years
Change in computed tomography score
Measured by Computed Tomography: Semiquantative score (i.e., Brody Score); Subscores including bronchiectasis, mucus plugging, airway wall thickening, consolidation, mosaic pattern and air trapping). Subscores will be expressed as the percentage of the maximum score on a scale of 0 (no disease) to 100 (maximal lung disease).
Measured: Change from baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Benden, Prof., MD, Principal investigator, University Hospital of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850002
- Sponsor's protocol ID
- 2018-02174
- Other IDs
- 2018
- Status last verified
- Jul 2019
- First submitted
- 14 Feb 2019
- Last updated
- 25 Jul 2019
- 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 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Clearance Index for the Early Detection and Monitoring of Lung Allograft Dysfunction After Adult Lung Transplantation
- ClinicalTrials.gov ID
- NCT03850002
- Acronym / sponsor ID
- 2018-02174
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Feb 2019 (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.
The aim of this project is to evaluate the ability of the lung clearance index (LCI) to detect early chronic lung allograft failure (CLAD) in adult lung transplant recipients over a period of 3 years.
Detailed description
This single center study consists of three parts:
- Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)
- Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)
- Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung transplant patients from University Hospital Zurich will be invited to participate.
Key inclusion criteria (2 listed)
- Male and female lung transplant recipients
- Written informed consent by the participant after information about the research project
Key exclusion criteria (3 listed)
- Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)
- Acute airway infection
- Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM
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 |
|---|---|---|
| Early detection of CLAD by Lung Clearance Index (LCI)Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD | Other | – |
Primary outcome
Change in lung clearance index (LCI)
Time frame: Change from baseline up to 3 years
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
14 secondary outcomes
Change in slope of acinar airways (Sacin)
Time frame: Change from baseline up to 3 years
Change in slope of conducting airways (Scond)
Time frame: Change from baseline up to 3 years
Change in forced expiratory volume in 1s (FEV1)
Time frame: Change from baseline up to 3 years
Change in forced vital capacity (FVC)
Time frame: Change from baseline up to 3 years
Change in forced expiratory flows at 25-75 of vital capacity (FEF25-75)
Time frame: Change from baseline up to 3 years
Change in total lung capacity (TLC)
Time frame: Change from baseline up to 3 years
Change in residual volume (RV)
Time frame: Change from baseline up to 3 years
Change in total lung capacity (TLC) / residual volume (RV) ratio
Time frame: Change from baseline up to 3 years
Change in diffusing capacity for nitric oxide (DLNO)
Time frame: Change from baseline up to 3 years
Change in diffusing capacity for carbon monoxide oxide (DLCO)
Time frame: Change from baseline up to 3 years
Change in DLNO/DLCO ratio
Time frame: Change from baseline up to 3 years
Change in transfer coefficient for nitric oxide (DLNO/VA)
Time frame: Change from baseline up to 3 years
Change in transfer coefficient for carbon monoxide (DLCO/VA)
Time frame: Change from baseline up to 3 years
Change in computed tomography score
Time frame: Change from baseline up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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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. This study is not recruiting at the moment.
Christian Benden, Prof., MD principal investigator
University Hospital of Zurich, Zurich, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Chronic Lung Allograft Dysfunction, run by University of Zurich.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung clearance index (LCI) (time frame: Change from baseline up to 3 years). 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 25 Jul 2019.