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

Completed · Phase 3

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID

NCT00755781

Run by

APT Pharmaceuticals, Inc.

People needed

284

Starts

2008-09-01

Expected to finish

2011-11-01

Last updated by the study team

2012-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• University of Florida Health Sciences Center — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• Loyola University Hospital — Maywood, Illinois, United States
• Indiana Methodist Research Institute — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• New York Presbyterian Hospital, Columbia University Med. Ctr. — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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