NCT Number: NCT06503770
A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
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.
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg, Leuven, Belgium
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS
Time frame: Up to 12 years
Change in FEV1 trajectory over time
Sponsors and collaborators
Lead sponsor
Zambon SpA
Industry
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 16, 2024
- Registry last updated
- May 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.