CompletedNot Applicable

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

United States, Belgium, Spain284 participantsStarted 2024-06-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

To evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS

Timeframe: Up to 12 years

Trial details

NCT IDNCT06503770

SponsorZambon SpA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Bronchiolitis Obliterans Syndrome Due to and After Lung Transplantation (Disorder) trials