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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 284

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg
• Spain
  • Andalucia
    • Córdoba, Andalucia, Spain, 14004
      • Hospital Universitario Reina Sofia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Universidad de Cantabria (UC) Hospital Universitario Marques de Valdecilla (HUMV)
• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus
    • Columbus, Ohio, United States, 43210
      • Baylor Scott and White Health Advanced Lung Disease Specialists
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott and White Health Advanced Lung Disease Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will include adult patients aged ≥ 18 years who are recipients of a lung transplant and diagnosed with CLAD-BOS from the first of January 2013 following transplantation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS	Change in FEV1 trajectory over time	Up to 12 years

Collaborators and Investigators

• Sponsor: Zambon SpA
• Investigators: Study Director: Bucchioni, MD, Zambon SpA

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Actual): April 2, 2025
• Study Completion (Actual): April 2, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organizing Pneumonia; Pathologic Processes; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Disease; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Syndrome; Bronchiolitis; Bronchiolitis Obliterans
• Other Study ID Numbers: Z8000N01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No