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

Completed

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

In brief

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.

Key facts

Study ID

NCT06503770

Run by

Zambon SpA

People needed

284

Starts

2024-06-27

Expected to finish

2025-04-02

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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