Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation

A Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation

A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.

Inclusion Criteria:

• A recipient of a single or double lung transplant (including heart-lung transplant)
• Age 18 years or older
• Able to produce a forced expiratory volume in one second (FEV1) of greater than one liter at randomization
• Eligible subjects must be enrolled within 70 days after receiving a lung transplant
• Clinical status sufficiently stable to enable routine post-transplant bronchoscopy with bronchoalveolar lavage (BAL) and chest X-ray (or equivalent i.e., chest computerized tomogram (CT)) prior to screening

Exclusion Criteria:

• Lung re-transplantation
• Documented allergy to propylene glycol and/or cyclosporine
• Documented respiratory or anastomotic infections unless on appropriate antimicrobial therapy with evidence of clinical response
• Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
• Women who are breastfeeding
• Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
• Malignancies diagnosed within one year prior to screening (with the exception of non-melanomatous skin cancers)