Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
Conditions
Sponsors
BREATH Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients of = 18 years. 2. Patients with diagnosis of BOS Grade 0-p with screening FEV1 between 85-81% of personal best FEV1 value post transplant plus risk factors as defined below, OR BOS Grade 1 with screening FEV1 between 80-66% of personal best FEV1 value post-transplant. Patients with a diagnosis of BOS Grade 0-p must have = 2 of these risk factors for BOS: - Primary graft dysfunction (PGD) - Acute cellular rejection - Lymphocytic bronchiolitis - Humoral rejection (e.g. de novo anti-human leukocyte antigen antibodies) - Gastro-oesophageal reflux and microaspiration - Infection (Viral, Bacterial, Fungal) - Persistent neutrophil influx and sequestration (bronchoalveolar lavage neutrophilia) - Autoimmunity (collagen V sensitization). 3. Patients with an FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed other causes for loss of lung function, such as infection, acute rejection, restrictive allograft syndrome (RAS), etc. 2. Cystic Fibrosis patients with multi-drug resistant infections not responding to available anti-microbial therapies. 3. Patients with donor-specific antibody (DSA) positivity at the Screening Visit. 4. Active bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit. 5. Mechanical ventilation within 12 weeks prior to Randomization. 6. Patient has baseline resting oxygen saturation of 2.5 mg/dL or requiring chronic dialysis. 10. Patients with liver disease and serum bilirubin > 3-fold upper normal value or transaminases > 2.5 upper normal value. 11. Patients with a history of malignancy, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas. 12. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy over the course of the clinical trial. 13. Women who are currently breastfeeding. 14. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to the Screening Visit. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use. 15. Patients who have received extracorporeal photophoresis (ECP) for treatment of BOS within 2 months prior to Randomization. 16. Patients who are currently participating in an interventional clinical trial. 17. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures. 18. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of add-on aerosolized L-CsA to Standard of Care therapy as compared to SoC therapy alone in the treatment of BOS in single lung transplant recipients.;Secondary Objective: Not applicable;Primary end point(s): Mean change in FEV1 (mL) from baseline.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in FEV1/FVC from baseline; • Time to Progression of BOS, defined as the earliest of the following: - Absolute decrease from baseline in FEV1 ³ 10% or ³ 200 mL and absolute decrease in FEV1/FVC of > 5%, OR - Change in BOS Grade, OR - Re-transplantation, OR - Death from respiratory failure This endpoint will be assessed in a combined analysis with a similar Phase III clinical trial, BT – L-CsA – 301 – SLT (BOSTON-1) which will be conducted in the same investigational centers in patients who have undergone double-lung transplantations. ;Timepoint(s) of evaluation of this end point: • Week 48 • Time to Progression | — |
Countries
Austria, Belgium, Denmark, France, Germany, Israel, Spain, United Kingdom, United States
Contacts
Public ContactChief Medical Officer
BREATH Therapeutics Inc.
Outcome results
None listed