Phase 2 Completed N=21 Randomized Treatment

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

Disorder Related to Lung Transplantation · Bronchiolitis Obliterans · Decreased Immunologic Activity · Chronic Rejection of Lung Transplant

Source: ClinicalTrials.gov NCT01650545 ↗

Enrolled (actual)

Serious AEs

76.2%

Results posted

Oct 2017

Primary outcomePrimary: Number Of Participants With Chronic Rejection Who Met Primary Combined End-point — 2; 5 Participants — p=0.03

Summary

This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number Of Participants With Chronic Rejection Who Met Primary Combined End-point	2; 5	0.03 sig
SECONDARY Cytokine Analysis From BAL Fluid in Lung	-2; 3.3; -0.9; -0.3; -2.0; 6.3	—
SECONDARY Overall Survival at 5 Years Follow-up	5; 0	—

Eligibility Criteria

Inclusion Criteria

Chronic rejection

Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed
Recipient of a double or single lung transplant
Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria

Active invasive bacterial, viral or fungal infection
Current mechanical ventilation
Pregnant or breast-feeding woman
Known hypersensitivity to cyclosporine A
Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
Receipt of an investigational drug as part of a clinical trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01650545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.