NCT00633373

Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: APT Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DRUG	Cyclosporine Inhalation Solution	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.

Timeline

• First posted: 2008-03-12
• Last updated: 2012-09-17

Locations

8 sites across 1 country: United States