Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation (CIS001)

APT Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Lung Transplant

Treatments

Drug: Cyclosporine Inhalation Solution (CIS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755781

CIS001

Details and patient eligibility

About

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.

Enrollment

284 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)