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

APT Pharmaceuticals, Inc.19 sites in 2 countries284 target enrollmentSeptember 2008

ConditionsLung Transplant

InterventionsCyclosporine Inhalation Solution (CIS)

DrugsCyclosporine Inhalation Solution (CIS)

Overview

Phase: Phase 3
Intervention: Cyclosporine Inhalation Solution (CIS)
Conditions: Lung Transplant
Sponsor: APT Pharmaceuticals, Inc.
Enrollment: 284
Locations: 19
Primary Endpoint: 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
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

November 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

APT Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

CIS

CIS in addition to standard immunosuppressive regimen.

Intervention: Cyclosporine Inhalation Solution (CIS)

Outcomes

Primary Outcomes

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

Time Frame: Assessed when symptoms of syndrome present

Secondary Outcomes

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)