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Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633373
First Posted: March 12, 2008
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.
March 5, 2008
March 12, 2008
September 17, 2012
 
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
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.
Not Provided
Expanded Access
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.
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00633373
APT Pharmaceuticals, Inc.
APT Pharmaceuticals, Inc.
Not Provided
Not Provided
APT Pharmaceuticals, Inc.
September 2012