BOS after single or double lung transplantation |
Iacono et al. 2019 (single or double LTx) [118] | NCT01650545 | IIb | Open-label, parallel (21) | LCsA 5 or 10 mg+SOC versus SOC | 1) A composite of BOS PFS, defined as time from randomisation to ≥20% decline in FEV1, re-transplantation or death, whichever occurred first (prolonged mechanical ventilation and irreversible respiratory failure equivalent to ≥20% decline of FEV1), and 2) BOS grade progression by grade changes from randomisation to study completion | Sep 2017 |
BOSTON-1 (single LTx) | NCT03657342 | III | Randomised, single-blind (110) | LCsA 5 mg+SOC versus SOC | Mean change in FEV1 from baseline to week 48 | July 2023 |
BOSTON-2 (double LTx) | NCT03656926 | III | Randomised, single-blind (152) | LCsA 10 mg+SOC versus SOC | Mean change in FEV1 from baseline to week 48 | July 2023 |
BOSTON-3 (OLE for BOSTON-1 and -2) | NCT04039347 | III | Open-label (220) | LCsA 5 mg or 10 mg | Mean change in FEV1 from baseline to week 24 | Apr 2024 |
BOS after HSCT |
BOSTON-4 | NCT04107675 | II | Randomised, single-blind (24) | LCsA 2.5, 5 or 10 mg versus placebo | Safety and tolerability | May 2022 |