Clinical trial registration number (name) | Patients (target n) | Phase | Design | Treatments | Primary end-point | Completion date |
Nintedanib | ||||||
NCT03805477 | BOS after HSCT (40) | II | Open-label | Nintedanib 150 mg twice daily | Adverse events leading to treatment interruption or discontinuation | Feb 2021 |
NCT03283007 (INFINITY study) | Grade 1–2 BOS after LTx (80) | III | Randomised, quadruple-blind | Nintedanib 150 mg twice daily versus placebo | Reduction in the rate of FEV1 decline from baseline to month 6 | Jun 2023 |
Pirfenidone | ||||||
NCT03315741 | BOS after HSCT (30) | I | Open-label | Pirfenidone ≤2403 mg·day−1 | Number of patients requiring a dose reduction for >21 days due to adverse events | Feb 2022 |
NCT03473340 (STOP-CLAD) | CLAD after LTx (60) | II | Randomised, double-blind | Pirfenidone 801–2403 mg·day−1 versus placebo | Per cent change in functional small airways disease as measured by parametric response mapping (HRCT) at week 24 | Mar 2022 |
NCT02262299 (EPOS) | Grade 1–3 BOS after LTx (90) | II/III | Randomised, double-blind | Pirfenidone 801–2403 mg·day−1 versus placebo | Change in FEV1 decline from baseline to month 6 | Dec 2019 |
BOS: bronchiolitis obliterans syndrome; HSCT: haematopoietic stem cell transplant; LTx: lung transplantation; FEV1: forced expiratory volume in 1 s; CLAD: chronic lung allograft dysfunction; HRCT: high-resolution computed tomography.