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

September 13, 2012 updated by: APT Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cyclosporine
No Intervention: SOC
Standard of care (SOC) therapy for lung transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Assessed when symptoms of syndrome present
Assessed when symptoms of syndrome present

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization
Time Frame: From study initiation through 2+ years after randomization
From study initiation through 2+ years after randomization
All cause mortality
Time Frame: From study initiation through 2+ years after randomization
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)
Time Frame: From study initiation through 2+ year after randomzation
From study initiation through 2+ year after randomzation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

APT Pharmaceuticals, Inc.

Investigators

  • Study Director: Stephen Dilly, MD PhD, APT Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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