Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2

Summary

Lung transplantation (TxP) is now a validated treatment of end-stage pulmonary diseases, but long-term graft and patient survival are still hampered by the development of chronic allograft dysfunction (CLAD) affecting \> 50% of patients. The investigators propose to conduct a phase III clinical randomized trial that will assess the efficacy of Nintedanib to hamper the lung decline in LTx recipients with BOS. This is the first trial testing this molecule in lung Tx recipients. If case of demonstrated effectiveness of Nintedanib, the benefit for lung transplant patients carrying a BO is high in terms of stabilization of lung function and enhancement of survival.

Timeline

Start

2019-10-30

Primary completion

2025-03-30

Completion

2025-03-30

Publications

• Brugiere O, Hirschi S, Reynaud-Gaubert M, Bunel V, Demant X, Le Pavec J, Falque L, Si Mohammed N, Tardivon C, Couffignal C; INFINITIx-BOS Consortium. Nintedanib in progressive bronchiolitis obliterans syndrome (BOS) grade 0p-1-2 in lung transplant recipients (INFINITIx-BOS): protocol of a French multicenter randomized controlled trial. Trials. 2026 Apr 11;27(1):298. doi: 10.1186/s13063-025-09314-7.

Drugs

Indications