Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung T… (NCT03656926) | Clinical Trial Compass
CompletedPhase 3
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
United States169 participantsStarted 2019-03-26
Plain-language summary
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients of \> or = 18 years who received a DLT at least 12 months prior to Screening.
✓. Patients with BOS diagnosis defined as CLAD-BOS phenotype with:
✓. screening FEV1 between 51% and 85% of personal best FEV1 value post-transplant OR
✓. screening FEV1 \> 85% of personal best FEV1 associated with EITHER a \> or = 200 mL decrease in FEV1 in the previous 12 months OR according to medical history showing BOS progression.
✓. Diagnosis of CLAD-BOS must have been made at least 12 months after lung transplantation and
✓. within 12 months prior to the Screening Visit OR
✓. more than 12 months from Screening and patient must have shown a decline in FEV1 \>or = 200 ml in the previous 12 months before Screening, which was not due to acute infection or acute organ rejection.
✓. Patients in whom the diagnosis of BOS had been confirmed by the elimination of other possible causes of obstructive or restrictive lung disease CLAD - restrictive allograft syndrome (RAS) phenotype.
Exclusion criteria
✕. Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (RAS) (CLAD - RAS phenotype, see Protocol Specific Definition ), etc.
✕. Cystic Fibrosis patients with multi-drug resistant infections not responding to available anti-microbial therapies.
What they're measuring
1
Mean Change in FEV1 (Liters) From Baseline to Week 48
. 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.
✕. Active acute 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.
✕. Mechanical ventilation (including CPAP) within 12 weeks prior to Randomization.
✕. Patients with uncontrolled hypertension.
✕. Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest.
✕. 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.