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Immunosuppressant

Liposomal Aerosol Cyclosporine for Bronchiolitis Obliterans

Phase 1 & 2
Waitlist Available
Led By Aldo T Iacono, MD
Research Sponsored by University of Maryland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

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.

Eligible Conditions
  • Bronchiolitis Obliterans
  • Lung Transplantation Disorders
  • Immunodeficiency
  • Lung Allograft Rejection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
Secondary outcome measures
Cytokine Analysis From BAL Fluid in Lung
Overall Survival at 5 Years Follow-up

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Aerosol CyclosporineExperimental Treatment2 Interventions
Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )
Group II: Conventional oral immune suppressionActive Control1 Intervention
Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone. Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporine
FDA approved

Find a Location

Who is running the clinical trial?

University of MarylandLead Sponsor
163 Previous Clinical Trials
303,022 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
158 Previous Clinical Trials
46,394 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
705 Previous Clinical Trials
378,439 Total Patients Enrolled
~2 spots leftby Sep 2025
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