Lung Transplant
Conditions
Keywords
lung, transplant, transplant rejection, Cyclosporine, bronchiolitis obliterans, aerosol
Brief summary
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.
Interventions
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.
Sponsors
APT Pharmaceuticals, Inc.
Eligibility
Sex/Gender
ALL
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.
Countries
United States
Outcome results
None listed