Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

NO_LONGER_AVAILABLE

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID

NCT00633373

Run by

APT Pharmaceuticals, Inc.

Last updated by the study team

2012-09-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known hypersensitivity to cyclosporine or propylene glycol (PG)
• Females who are pregnant or are considering becoming pregnant
• Females who are breast feeding a child.

Where it is running

• 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 — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor Clinic, Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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