Lung Transplant
Conditions
Keywords
lung transplant, lung transplant recipient, bronchiolitis obliterans syndrome, bronchiolitis obliterans, single lung transplant, double lung transplant, heart-lung transplant, Aerosol
Brief summary
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.
Interventions
Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration (up to 3 years)
Sponsors
APT Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee | Assessed when symptoms of syndrome present |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization | From study initiation through 2+ years after randomization |
| All cause mortality | From study initiation through 2+ years after randomization |
| Duration of event-free survival, corresponding to the length of time between date of randomization and either death or the occurrence of serious bacterial and viral infections that start in the lungs (defined by reporting of a SAE) | From study initiation through 2+ year after randomzation |
Countries
Canada, United States
Outcome results
None listed