CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Liposomal aerosol cyclosporine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01650545
NCT01650545Phase 2Completed
CompareCT.gov

A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation

University of Maryland, Baltimore·interventional·Posted Jul 26, 2012·Updated Jun 1, 2023

In Brief

A Phase 2 clinical trial evaluating Liposomal aerosol cyclosporine and standard immune suppression, oral for Disorder Related to Lung Transplantation and 3 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2015
Study CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.9 years ago

Interventions

Liposomal aerosol cyclosporinedrug

inhaled form of immune suppression

standard immune suppression, oralother

conventional drug Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin