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

NCT06503770 | Completed

• 1 other identifier: Z8000N01
• Study Type: observational
• Target: 284
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS

  Change in FEV1 trajectory over time

  Up to 12 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis
• Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013
• Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant
• 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.

You may not qualify if:

• 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)
• Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period
• Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.

Sponsors & Collaborators

• Zambon SpA: lead

Study Sites (6)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Baylor Scott and White Health Advanced Lung Disease Specialists

Columbus, Ohio, 43210, United States

Location

Baylor Scott and White Health Advanced Lung Disease Specialists

Dallas, Texas, 75246, United States

Location

Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg

Leuven, Leuven, 3000, Belgium

Location

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Universidad de Cantabria (UC) Hospital Universitario Marques de Valdecilla (HUMV)

Santander, Cantabria, 39008, Spain

Location

Study Officials

• Bucchioni, MD

  Zambon SpA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 16, 2024
• Study Start: June 27, 2024
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); ES (2); BE (1)