Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.
- Conditions
- Bronchiolitis Obliterans Syndrome in Patients post Single Lung TransplantationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-003204-39-FR
- Lead Sponsor
- BREATH Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
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 < 0.8.
4. Patients in whom the diagnosis of BOS has been confirmed by the elimination of other possible causes of obstructive lung disease.
5. Patients with a diagnosis of BOS 0-p or BOS 1 made at least 1 year after transplant surgery and within 6 months prior to the Screening Visit.
6. Patients receiving a tacrolimus-based basic immunosuppression regimen in combination with MMF (or equivalent) and corticosteroids. This basic immunosuppression regimen must be stable (without changes to doses) for at least 4-weeks prior to Randomization.
7. Patients must consent to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use).
8. Patients must be receiving prophylaxis against Cytomegalovirus (CMV) and Pneumocystis pneumonia.
9. Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation.
10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and must agree to use one of the methods of contraception listed in Appendix II for their duration of clinical trial participation.
11. Patients have no concomitant diagnoses that are considered fatal within one year (12 months).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
1. Patients with confirmed other causes for loss of lung function, such as infection, acute rejection, restrictive allograft syndrome (RAS), etc.
2. Patients with Cystic Fibrosis.
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 < 89% on room air or use of supplemental oxygen.
7. History or presence of bronchial strictures or airway stents or airways requiring balloon dilatations to maintain patency.
8. Known hypersensitivity to L-CsA or to cyclosporine A.
9. Patients with chronic renal failure defined as serum creatinine > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method