Phase 2 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

Bottom Line

View on ClinicalTrials.gov: NCT01650545 ↗

Enrolled (actual)

Serious AEs

76.2%

Results posted

Oct 2017

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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Liposomal aerosol cyclosporine (Drug); standard immune suppression, oral (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Aug 2015

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	—

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.

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.