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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00755781
First received: September 17, 2008
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Lung Transplant
Drug: Cyclosporine Inhalation Solution (CIS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by APT Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization [ Time Frame: From study initiation through 2+ years after randomization ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: From study initiation through 2+ years after randomization ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: From study initiation through 2+ year after randomzation ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: September 2008
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CIS
CIS in addition to standard immunosuppressive regimen.
Drug: Cyclosporine Inhalation Solution (CIS)
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)
Other Name: Cyclosporine
No Intervention: SOC
Standard of care (SOC) therapy for lung transplant recipients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755781

Locations
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
University of Florida Health Sciences Center
Gainesville, Florida, United States, 32610
Mayo Clinic
Jacksonville, Florida, United States, 32224
Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Loyola University Hospital
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Methodist Research Institute
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
New York Presbyterian Hospital, Columbia University Med. Ctr.
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22402
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
APT Pharmaceuticals, Inc.
Investigators
Study Director: Stephen Dilly, MD PhD APT Pharmaceuticals, Inc.
  More Information

Publications:

Responsible Party: APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00755781     History of Changes
Other Study ID Numbers: CIS001
Study First Received: September 17, 2008
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by APT Pharmaceuticals, Inc.:
lung transplant
lung transplant recipient
bronchiolitis obliterans syndrome
bronchiolitis obliterans
single lung transplant
double lung transplant
heart-lung transplant
Aerosol

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Syndrome
Bronchiolitis
Bronchiolitis Obliterans
Disease
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Cyclosporins
Cyclosporine
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014