NCT06503770

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 284 (actual)
• Sponsor: Zambon SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-04-02
• Completion: 2025-04-02
• First posted: 2024-07-16
• Last updated: 2025-05-20

Locations

6 sites across 3 countries: United States, Belgium, Spain