A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2

Zambon SpA0 sites170 target enrollmentDecember 10, 2018

ConditionsChronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung Transplantation Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung Transplantation
Sponsor: Zambon SpA
Enrollment: 170
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 10, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Zambon SpA

Eligibility Criteria

Inclusion Criteria

•1\. Adult patients of \= 18 years who received a double lung transplant at
•least 12 months prior to Screening.
•2\. Patients with BOS diagnosis defined as CLAD\-BOS phenotype with:
•a) Screening FEV1 between 85\-51% of personal best FEV1 value posttransplant.
•b) Screening FEV1 \>85% of personal best FEV1 associated with EITHER
•a \= 200 mL decrease in FEV1 in the previous 12 months OR according to
•medical history showing BOS progression.
•3\. Diagnosis of CLAD\-BOS must be made at least 12 months after lung
•transplantation and
•a) within 12 months prior to the screening visit.

Exclusion Criteria

•1\. Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD – RAS phenotype, see Protocol Specific Definitions),etc.
•2\. Cystic Fibrosis patients with multi\-drug resistant infections not responding to available anti\-microbial therapies.
•3\. Patients with acute antibody\-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable levels of donor specific antibodies (DSA) at the Screening Visit are eligible for the study.
•4\. Active bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the Investigator are eligible for the study
•5\. Mechanical ventilation (including CPAP) within 12 weeks prior to Randomization.
•6\. Patients with uncontrolled hypertension.
•7\. Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest.
•8\. Evidence of functional airway stenosis (e.g., bronchomalacia/tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and/or Randomization Visit.
•9\. Known hypersensitivity to L\-CsA or cyclosporine A.
•10\. Patients with chronic renal failure defined as serum creatinine \> 2\.5 mg/dL at screening or requiring chronic dialysis.