Title
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Phase
N/ALead Sponsor
APT Pharmaceuticals, Inc.Study Type
Expanded AccessStatus
No longer availableIndication/Condition
Lung TransplantIntervention/Treatment
cyclosporine ...Study Participants
NoneCurrently 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.
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.
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.
