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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bucchioni, MD | Zambon SpA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States | ||
| Baylor Scott and White Health Advanced Lung Disease Specialists |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2026 | |
| Reset | Mar 26, 2026 | |
| Release | May 25, 2026 |
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| Columbus |
| Ohio |
| 43210 |
| United States |
| Baylor Scott and White Health Advanced Lung Disease Specialists | Dallas | Texas | 75246 | United States |
| Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg | Leuven | Leuven | 3000 | Belgium |
| Hospital Universitario Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
| Universidad de Cantabria (UC) Hospital Universitario Marques de Valdecilla (HUMV) | Santander | Cantabria | 39008 | Spain |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2026 | Mar 26, 2026 | |||
| May 25, 2026 | Jun 22, 2026 | |||
| Jun 25, 2026 |