Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

N/ANo Longer AvailableNCT00633373

APT Pharmaceuticals, Inc.

Overview

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Study Type

EXPANDED_ACCESS

Conditions

Lung Transplant

Interventions

Cyclosporine Inhalation SolutionDRUG

Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Single-or double-lung transplant recipients who have a high risk for developing chronic rejection * Single or double-lung transplant recipients who have developed chronic rejection * Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy Exclusion Criteria: * Known hypersensitivity to cyclosporine or propylene glycol (PG) * Females who are pregnant or are considering becoming pregnant * Females who are breast feeding a child.

Locations (8)

University of California at San Francisco

San Francisco, California, United States

University of Florida Health Sciences Center

Gainesville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

University of Maryland Medical Center

Data from ClinicalTrials.gov

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