EUCTR2018-003205-25-ES
Active, not recruiting
Phase 1
A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
- Sponsor
- BREATH Therapeutics Inc.
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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).
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 \< 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.
Outcomes
Primary Outcomes
Not specified
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