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Clinical Trials/EUCTR2018-003205-25-DE
EUCTR2018-003205-25-DE
Active, not recruiting
Phase 1

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 enrollmentNovember 15, 2018
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ConditionsChronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Double Lung TransplantationTherapeutic 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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 15, 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

Outcomes

Primary Outcomes

Not specified

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