Clinical trial NCT06503770: A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
Official title: A Retrospective Chart Review Study of Patients With Chronic Lung Allograft Dysfunction-Bronchiolitis Obliterans Syndrome (CLAD-BOS) Post Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder)
Lead sponsor: Zambon SpA
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients ≥ 18 years of age on the date of CLAD-BOS diagnosis
2. Patients with a CLAD-BOS clinician diagnosis from as early as 01 January 2013
3. Patients with CLAD-BOS clinician diagnosis made at least 12 months after lung transplant
4. 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:

1. 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)
2. Patients who have been exposed to any investigational medical products in the 4 weeks prior to index date or during the post-diagnosis period
3. Patients with confirmed other CLAD phenotype (e.g., restrictive allograft syndrome) according to physician's judgment.

Primary outcomes:
measure: To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS
timeFrame: Up to 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Columbus
country: United States
facility: Baylor Scott and White Health Advanced Lung Disease Specialists
state: Ohio
city: Dallas
country: United States
facility: Baylor Scott and White Health Advanced Lung Disease Specialists
state: Texas
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven (UZ Leuven) Campus Gasthuisberg
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucia
city: Santander
country: Spain
facility: Universidad de Cantabria (UC) Hospital Universitario Marques de Valdecilla (HUMV)
state: Cantabria
Study officials:
affiliation: Zambon SpA
name: Bucchioni, MD
role: STUDY_DIRECTOR
References: