Lung Clearance Index and Lung Allograft Dysfunction

July 24, 2019 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This single center study consists of three parts:

  1. Characterisation of the Zurich lung transplant cohort regarding CLAD status and pulmonary function impairment (cross-sectional, study part I)
  2. Evaluation of test-retest reliability of LCI in 20 clinically stable lung transplant recipients during three consecutive study visits (study part II)
  3. Prospective cohort study to test the ability of LCI to detect early CLAD in patients without prior CLAD (study part III)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult lung transplant patients from University Hospital Zurich will be invited to participate.

Description

Inclusion Criteria:

  • Male and female lung transplant recipients
  • Written informed consent by the participant after information about the research project

Exclusion Criteria:

  • Any contraindication to perform pulmonary function tests (e.g., persistent pneumothorax)
  • Acute airway infection
  • Chronic infection due to Burkholderia spp and nontuberculosis mykobacteria NTM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from baseline up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in slope of acinar airways (Sacin)
Time Frame: Change from baseline up to 3 years
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Change from baseline up to 3 years
Change in slope of conducting airways (Scond)
Time Frame: Change from baseline up to 3 years
Measured by multiple breath nitrogen washout (Exhalyzer® D; Eco Medics AG)
Change from baseline up to 3 years
Change in forced expiratory volume in 1s (FEV1)
Time Frame: Change from baseline up to 3 years
Measured by Spirometry (Geratherm Respiratory GmbH)
Change from baseline up to 3 years
Change in forced vital capacity (FVC)
Time Frame: Change from baseline up to 3 years
Measured by Spirometry (Geratherm Respiratory GmbH)
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
Measured by Spirometry (Geratherm Respiratory GmbH)
Change from baseline up to 3 years
Change in total lung capacity (TLC)
Time Frame: Change from baseline up to 3 years
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Change from baseline up to 3 years
Change in residual volume (RV)
Time Frame: Change from baseline up to 3 years
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
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
Measured by Bodyplethysmography (Geratherm Respiratory GmbH)
Change from baseline up to 3 years
Change in diffusing capacity for nitric oxide (DLNO)
Time Frame: Change from baseline up to 3 years
Single-breath measurements (Jaeger MasterScreenTM PFT system)
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
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change from baseline up to 3 years
Change in DLNO/DLCO ratio
Time Frame: Change from baseline up to 3 years
Single-breath measurements (Jaeger MasterScreenTM PFT system)
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
Single-breath measurements (Jaeger MasterScreenTM PFT system)
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
Single-breath measurements (Jaeger MasterScreenTM PFT system)
Change from baseline up to 3 years
Change in computed tomography score
Time Frame: Change from baseline up to 3 years
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).
Change from baseline up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Benden, Prof., MD, University Hospital of Zurich, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-02174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings