A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-27

Study Completion Date

2025-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to describe the forced expiratory volume in 1 second (FEV1) decline and natural disease evolution in patients affected by CLAD-BOS after lung transplantation and receiving an immunosuppressive therapy as standard of care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microparticles and Bronchiolitis Obliterans Syndrome

NCT02458274

Bronchiolitis Obliterans

COMPLETED

Noninvasive Early Detection of Lung Allograft Dysfunction After Lung Transplantation With Multiple Breath Washout Test

NCT05586906

Chronic Rejection of Lung Transplant

RECRUITING NA

Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction

NCT02836938

Chronic Lung Allograft Dysfunction (CLAD)

COMPLETED

Chronic Lung Allograft Dysfunction MRI Study

NCT06406777

Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

RECRUITING PHASE1/PHASE2

Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients

NCT01204970

Lung Transplantation Chronic Obstructive Pulmonary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective, multinational, multicenter chart review study of adult patients with clinically diagnosed CLAD-BOS after lung transplantation. All data will be retrospectively collected from patient records starting from lung transplantation date through last date of available data, and as such, no interventions will be applied as part of this study.

The observational period for each patient will be from lung transplant date until last date of data available or death, whichever occurs earlier and will include the following time periods:

Diagnosis window: 01 January 2013 through most recent data available.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis
2. Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013
3. Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant
4. Patients received at least basic maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to mycophenolate mofetil or azathioprine (or other anti-proliferative agent), and a systemic corticosteroid such as prednisone as third agent for at least 1 month before the index date. As long as the basic maintenance regimen is maintained for the abovementioned period, patients will still be considered eligible for the study even if they are receiving other immunosuppressive agents in addition to the basic maintenance regimen.

Exclusion Criteria

1. Patients with severe concomitant disease at the time of index date, which according to physician's judgment, can interfere with CLAD-BOS progression and mortality (e.g., malignancies, severe chronic diseases)
2. Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period
3. Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No