Lung-transplant RecipientsPhase 3INFINITx BOSNCT03283007
Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2
A Phase 3 study testing Nintedanib in people with Lung-transplant Recipients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung-transplant Recipients
- What is being tested?
- Nintedanib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 30 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Related to LTx
- Criteria of restrictive allograft syndrome (RAS) at V0, including the following: (1) Decline of VC < 20% of best post-LTx value (FVCBest is defined as the average of the two FVCs associated with the two PFTs used in FEV1 baseline calculation for CLAD diagnosis) AND FEV1/VC > 0.7 AND (2) Thorax HRCT at entry demonstrate new significant findings which are compatible with RAS like interstitial fibrosis, consolidation, appearances suggesting Restrictive Allograft Syndrome (RAS)
- FEV1 and/or FV and/or TLC decline related to other nonCLAD causes (eg Diaphragm dysfunction, pneumothorax or pleural effusion, evolutive bronchial stricture within the previous 3 months)
- At V0, patients who already have developed severe BOS grade 3
- Patients with severe comorbidity complicating CLAD which might determine the prognosis and functional level of the patient (e.g. evolutive invasive aspergillosis or mycobacterial infection within the last 3 months, active malignant disease within the last 12 months)
- At visit V1 (end of screening period), diagnosis of documented acute cellular (AR) perivascular rejection higher than grade A1 within the 4 prior weeks OR diagnosis of acute antibody-mediated rejection within the 4 prior weeks, based on presence of all 4 following criteria: 1) acute lung allograft dysfunction, 2) detection of donor-specific antibodies, 3) histological findings compatible with AMR on transbronchial lung biopsy TBBx, and 4) detection of C4d > 50% on TBBx
Show all 29Show fewer
- At visit V1 (end of screening period), diagnosis of documented acute pulmonary infection within the 2 prior weeks, on the basis of the following: 1) clinical, radiological and physiological deterioration; AND 2) isolation of an organism from a clinically relevant BAL fluid culture; AND 3) antibiotic therapy resulting in a full recovery and return to pre-morbid lung function
- Previous treatment with Nintedanib after the date of lung transplantation (Treatment with Nintedanib before lung transplantation is not an exclusion criteria)
- Ongoing treatment with photopheresis at V1 or planned treatment with photopheresis within the study period.
- Laboratory parameter thresholds
- Within the 2 weeks prior to V1, renal insufficiency with following criteria: Creatinine clearance <30 ml/min estimated by the Cockcroft-Gault equation
- Within the 2 weeks prior to V1, any of the following liver test criteria above the specified limit: Total bilirubin > 1.5 above the upper limit of the normal range (ULN), except in patients with predominantly unconjugated hyperbilirubinemia (e.g., Gilbert's syndrome). Aspartate or alanine aminotransferase (AST or ALT) >3 × ULN (refer to the protocole, for the management of liver enzyme elevation).
- General exclusion criteria
- Pregnancy or lactation (women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent to three months after the end of the patient study participation)
- Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening visit (V0)
- Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment
- Patients not able to understand and follow study procedures including completion of self-administered questionnaires without help.
- Other diseases
- Cardiac disease: (1) History of myocardial infarction within 6 months of visit 1 or unstable angina within 6 months of visit 1; (2) Presence of aortic stenosis (AS) per investigator judgement at visit 1; (3) Severe chronic heart failure: defined by left ventricular ejection fraction (EF) < 25% per investigator judgement at visit 1
- Known allergy or hypersensitivity to Nintedanib or intolerance to nintedanib, peanut or soya, or any other components of the study medication
- Bleeding Risk: Known genetic predisposition to bleeding; Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) or high dose antiplatelet therapy (acetyl salicylic acid >325 mg/day, or clopidogrel >75 mg/day) [NB: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.U. s.c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited]; History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1; History of haemoptysis or haematuria within 3 months prior to visit 1, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1; International normalised ratio (INR) > 2 at visit 1; Prothrombin time (PT) and activated partial thromboplastin time (aPTT) > 150% of institutional ULN at visit 1
- Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment)
- Planned major surgery during the trial participation
- History of thrombotic event (including stroke and transient ischemic attack) within 6 months of visit 1
- Second-degree or third-degree atrioventricular (AV) block on electrocardiogram (ECG) per investigator judgement at visit 1
- i) Hypotension (systolic blood pressure [SBP] < 90 mm Hg or diastolic blood pressure [DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1 ii) Uncontrolled systemic hypertension (SBP > 160 mmHg; DBP > 100 mmHg) at visit 1
- Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism
- Retinitis pigmentosa, or History of vision loss, or History of nonarteritic ischemic optic neuropathy
- Ongoing treatment with pirfenidone at V1 or planned treatment with pirfenidone within the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2
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.
Read the detailed description
Introduction: 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. Obliterative bronchiolitis (OB), the obstructive CLAD, is the most common manifestation of CLAD, and affects > 50% of recipients who survive the early post-transplant period. OB is thought to arise from repeated injury to graft epithelial cells, leading to fibrous scarring and obliteration of the small airway lumen, as a result of dysregulated fibrotic repair and loss of peribronchial microvasculature. The patchy histopathologic distribution at onset makes it difficult to confirm histopathologically the diagnosis of OB from lung specimens. Hence, bronchiolitis obliterans syndrome (BOS) has become a generally accepted surrogate diagnostic of OB, characterized physiologically by progressive airflow limitation, with a median monthly decline of FEV1 of about 50 ml. Survival after onset of BOS is poor, reported as < 50% at 3 years after onset of disease, due to end-stage respiratory failure. Thus far, there is currently no approved treatment to stabilize BOS disease, and especially no treatment addressing the fibrotic lung graft manifestation of BOS. The crucial role of a dysregulated fibrotic repair has now been demonstrated in BOS, with the following: (i) Architectural remodelling with fibrosis and scarring of airways involving myofibroblasts; (ii) Increased extracellular matrix synthetic; (iii) Epithelial-mesenchymal transition mechanism; (iv) Role of growth factors PDGF, VEGF, FGF, and IGF-1 shown in BO mechanisms (animals and humans studies).
These data strongly suggest the potential role of tyrosine kinase inhibitors (TKI) that target these growth factors involved in the post-TxP BO. In this axis, the new TKI Nintedanib, which has recently been demonstrated as effective in the treatment of idiopathic pulmonary fibrosis (IPF) in large-scale randomized studies (8) appears as a candidate molecule capable of stopping the fibroproliferative process and stabilize the development of a CLAD after TxP. Whereas Nintedanib is a validated and available treatment in patients with IPF, paucity of data are currently available in lung-transplant recipients.
Primary objective: to assess Nintedanib efficacy in the reduction of the rate of decline of FEV1 (forced expiratory volume in 1 sec) in BOS post-LTx at a dose of 150 mg twice daily (bid) compared to placebo over 6 months.
Secondary objectives: to assess Nintedanib efficacy and tolerance in the treatment of BOS grade 0p-1-2 post-lung transplantation.
Experimental design: a 2 groups parallel, randomized, prospective multicentric placebo-controlled phase III trial to assess Nintedanib superiority versus placebo.
Eligible LTx recipients with BOS are to be randomized in a 1:1 ratio to receive either Nintedanib 150 mg BID or the matching placebo treatment for 6 months.
The follow-up of patients with BOS included in the trial will be similar to usual and standard care in both arms of the study (Nintedanib group and placebo group).
The intervention group is expected to be beneficial compared to the placebo group.
- Conditions
- Lung-transplant Recipients
- Being tested
- Nintedanib, Placebo
- Keywords
- Nintedanib, lung transplantation, bronchiolitis obliterans syndrome
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Eligible LTx recipients with BOS receive Nintedanib treatment at a dose of 150 mg twice daily (bid) for 6 months
PlaceboDrug
Eligible LTx recipients with BOS receive Nintedanib 150 mg BID matching placebo treatment for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib | Experimental | Eligible LTx recipients with BOS receive Nintedanib treatment at a dose of 150 mg twice daily (bid) for 6 months Receives: Drug: Nintedanib |
| Placebo | Placebo comparator | Eligible LTx recipients with BOS receive Nintedanib 150 mg BID matching placebo treatment for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The absolute difference of FEV1 in mL over 6 months of treatment defined by the rate of decline between inclusion (Visit 1) and month 6 (Visit 4) will be compared between Nintedanib versus Placebo groups
Measured: 6 months
Secondary outcomes (7)
Nintedanib efficacy on exercise tolerance in LTx recipients
Nintedanib efficacy on exercise tolerance will be assessed by the absolute change from baseline in the 6-min Walking Test at month 6 in Nintedanib group compared to Placebo group
Measured: 6 months
Nintedanib efficacy on quality of life improvement in LTx recipients
Nintedanib efficacy on quality of life improvement will be assessed by the absolute change from baseline in SGRQ (Saint George's Respiratory Questionnaire) total score at month 6 in Nintedanib group compared to Placebo group
Measured: 6 months
Nintedanib efficacy to hamper FEV1 decrease in LTx recipients
Nintedanib efficacy to hamper FEV1 decrease will be assessed by the absolute change of FEV1 in mL at month 6 by a repeated FEV1 measurements (at month 0, month 1, month 3, month 6) in Nintedanib group compared to Placebo group
Measured: 6 months
Nintedanib efficacy to hamper progression of BOS in LTx recipients
Nintedanib efficacity to hamper progression of BOS will be assessed by the proportion of patients with change in BOS grade and graft failure (defined as death or retransplantation) in Nintedanib group compared to Placebo group
Measured: 6 months
Nintedanib efficacy on the change of Oxygen saturation in LTx recipients
Nintedanib efficacity on the change of Oxygen saturation will be assessed by the absolute change from baseline in Oxygen saturation (expressed in percent) rest evaluated from baseline at month 6 in Nintedanib group compared to Placebo group
Measured: 6 months
Nintedanib tolerance in LTx recipients
Nintedanib tolerance in lung-transplant recipients over 6 months will be assessed in comparing occurrence of adverse events between both arms (Nintedanib vs Placebo)
Measured: 6 months
Explanatory parameters of fibrotic pathways
Explanatory parameters of fibrotic pathways will be assessed by absolute changes of biomarkers of alveolar cells injury (Krebs von den Lungen-6 (KL6), surfactant apoprotein D (SPD), and growth factors as vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF)) since baseline at month 6
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start30 Oct 2019
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung-transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Brugière, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283007
- Sponsor's protocol ID
- P160907
- Acronym
- INFINITx BOS
- Status last verified
- May 2025
- First submitted
- 6 Sep 2017
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41964069
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2
- ClinicalTrials.gov ID
- NCT03283007
- Acronym / sponsor ID
- INFINITx BOS / P160907
- Conditions
- Lung-transplant Recipients
- Keywords
- Nintedanib, lung transplantation, bronchiolitis obliterans syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: 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. Obliterative bronchiolitis (OB), the obstructive CLAD, is the most common manifestation of CLAD, and affects > 50% of recipients who survive the early post-transplant period. OB is thought to arise from repeated injury to graft epithelial cells, leading to fibrous scarring and obliteration of the small airway lumen, as a result of dysregulated fibrotic repair and loss of peribronchial microvasculature. The patchy histopathologic distribution at onset makes it difficult to confirm histopathologically the diagnosis of OB from lung specimens. Hence, bronchiolitis obliterans syndrome (BOS) has become a generally accepted surrogate diagnostic of OB, characterized physiologically by progressive airflow limitation, with a median monthly decline of FEV1 of about 50 ml. Survival after onset of BOS is poor, reported as < 50% at 3 years after onset of disease, due to end-stage respiratory failure. Thus far, there is currently no approved treatment to stabilize BOS disease, and especially no treatment addressing the fibrotic lung graft manifestation of BOS. The crucial role of a dysregulated fibrotic repair has now been demonstrated in BOS, with the following: (i) Architectural remodelling with fibrosis and scarring of airways involving myofibroblasts; (ii) Increased extracellular matrix synthetic; (iii) Epithelial-mesenchymal transition mechanism; (iv) Role of growth factors PDGF, VEGF, FGF, and IGF-1 shown in BO mechanisms (animals and humans studies).
These data strongly suggest the potential role of tyrosine kinase inhibitors (TKI) that target these growth factors involved in the post-TxP BO. In this axis, the new TKI Nintedanib, which has recently been demonstrated as effective in the treatment of idiopathic pulmonary fibrosis (IPF) in large-scale randomized studies (8) appears as a candidate molecule capable of stopping the fibroproliferative process and stabilize the development of a CLAD after TxP. Whereas Nintedanib is a validated and available treatment in patients with IPF, paucity of data are currently available in lung-transplant recipients.
Primary objective: to assess Nintedanib efficacy in the reduction of the rate of decline of FEV1 (forced expiratory volume in 1 sec) in BOS post-LTx at a dose of 150 mg twice daily (bid) compared to placebo over 6 months.
Secondary objectives: to assess Nintedanib efficacy and tolerance in the treatment of BOS grade 0p-1-2 post-lung transplantation.
Experimental design: a 2 groups parallel, randomized, prospective multicentric placebo-controlled phase III trial to assess Nintedanib superiority versus placebo.
Eligible LTx recipients with BOS are to be randomized in a 1:1 ratio to receive either Nintedanib 150 mg BID or the matching placebo treatment for 6 months.
The follow-up of patients with BOS included in the trial will be similar to usual and standard care in both arms of the study (Nintedanib group and placebo group).
The intervention group is expected to be beneficial compared to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib | Experimental | Drug: NintedanibEligible LTx recipients with BOS receive Nintedanib treatment at a dose of 150 mg twice daily (bid) for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboEligible LTx recipients with BOS receive Nintedanib 150 mg BID matching placebo treatment for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (29 listed)
- Related to LTx
- Criteria of restrictive allograft syndrome (RAS) at V0, including the following: (1) Decline of VC < 20% of best post-LTx value (FVCBest is defined as the average of the two FVCs associated with the two PFTs used in FEV1 baseline calculation for CLAD diagnosis) AND FEV1/VC > 0.7 AND (2) Thorax HRCT at entry demonstrate new significant findings which are compatible with RAS like interstitial fibrosis, consolidation, appearances suggesting Restrictive Allograft Syndrome (RAS)
- FEV1 and/or FV and/or TLC decline related to other nonCLAD causes (eg Diaphragm dysfunction, pneumothorax or pleural effusion, evolutive bronchial stricture within the previous 3 months)
- At V0, patients who already have developed severe BOS grade 3
- Patients with severe comorbidity complicating CLAD which might determine the prognosis and functional level of the patient (e.g. evolutive invasive aspergillosis or mycobacterial infection within the last 3 months, active malignant disease within the last 12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibEligible LTx recipients with BOS receive Nintedanib treatment at a dose of 150 mg twice daily (bid) for 6 months | Drug | Nintedanib |
| PlaceboEligible LTx recipients with BOS receive Nintedanib 150 mg BID matching placebo treatment for 6 months | Drug | Placebo |
Primary outcome
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
Time frame: 6 months
The absolute difference of FEV1 in mL over 6 months of treatment defined by the rate of decline between inclusion (Visit 1) and month 6 (Visit 4) will be compared between Nintedanib versus Placebo groups
7 secondary outcomes
Nintedanib efficacy on exercise tolerance in LTx recipients
Time frame: 6 months
Nintedanib efficacy on quality of life improvement in LTx recipients
Time frame: 6 months
Nintedanib efficacy to hamper FEV1 decrease in LTx recipients
Time frame: 6 months
Nintedanib efficacy to hamper progression of BOS in LTx recipients
Time frame: 6 months
Nintedanib efficacy on the change of Oxygen saturation in LTx recipients
Time frame: 6 months
Nintedanib tolerance in LTx recipients
Time frame: 6 months
Explanatory parameters of fibrotic pathways
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41964069Brugiere 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Brugière, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nintedanib in people with Lung-transplant Recipients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.