NCT06503770Completed
A Retrospective Chart Review Study of Patients With CLAD-BOS Post Lung Transplantation
A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
The Primary Objective of this study was to evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS. The Secondary Objectives of this study were: * To describe demographics of patients diagnosed with CLAD-BOS * To describe clinical characteristics following lung transplantation for patients diagnosed with CLAD-BOS * To evaluate the trajectory of other relevant spirometry parameters (ie, FVC, FEV1/FVC, FEF25-75%) * To evaluate the OS of patients diagnosed with CLAD-BOS * To evaluate the time to first CLAD-BOS progression * To evaluate the cumulative incidence of CLAD-BOS progression * To evaluate the rate of hospitalization due to respiratory failure after CLAD-BOS onset * To evaluate the incidence of concomitant respiratory disease * To evaluate the incidence of concomitant non-respiratory disease * To describe the use of concomitant treatments and procedures for CLAD-BOS.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 284 (actual)
- First submitted
- 8 Jul 2024
- Start date
- 27 Jun 2024
- Primary completion date
- 9 Apr 2025
- Lead sponsor
- Zambon SpA
- NCT number
- NCT06503770
What you commit to
- Study type: Observational
- Participants enrolled: 284
- From 27 Jun 2024 to the primary completion date, 9 Apr 2025
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaire Ziekenhuizen Leuven (UZ Leuven) Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Marques de Valdecilla (HUMV) Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Cleveland Clinic Transplantation Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Baylor Scott and White Health Center for Advanced Heart and Lung Disease Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.