CompletedPhase 3

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

France58 participantsStarted 2019-10-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Written informed consent signed prior to entry into the trial
✓. Patients ≥18 years of age when signing his/her informed consent
✓. Patients at least at 6 months post-LTx
✓. Single- or double-LTx or combined cardio-pulmonary LTx are eligible
✓. Patients must have diagnosis of BOS defined as a decrement of 10% or more in forced expiratory volume in 1 seconde (FEV1) compared to post-transplant baseline FEV1 individualized for each patient according to ISHLT definition. The documented post-LTx baseline value of FEV1 is defined as the mean of the 2 highest values measured at least 3 weeks apart according to ISHLT criteria, and post-LTx VC measurements
✓. Patients must have BOS grade 0p, 1 or 2
✓. Patients must have documented progressive BOS as demonstrated by the following criteria: at least 3 FEV1 and VC measurements in the last 12 months prior V1, each at least 3 weeks apart, with a total decline of at least 200ml in FEV1 in these last 12 months AND FEV1/VC\<0.7
✓. Azithromycin therapy for at least 4 weeks prior to V1, with an Azithromycin dose of minimum 250 mg/day at least 3 times per week as this is considered standard therapy for bronchiolitis obliterans syndrome

Exclusion criteria

What they're measuring

Nintedanib efficacy in the reduction of the rate of decline of FEV1 (forced expiratory volume in 1 sec) in BOS post-LTx grade 0p-1-2 at a dose of 150 mg twice daily (bid) compared to placebo over 6 months

Timeframe: 6 months

Trial details

NCT IDNCT03283007

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-30

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