Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00633373
First received: March 5, 2008
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.


Condition Intervention
Lung Transplant
Drug: Cyclosporine Inhalation Solution

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Resource links provided by NLM:


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

Intervention Details:
    Drug: Cyclosporine Inhalation Solution
    Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
  • Single or double-lung transplant recipients who have developed chronic rejection
  • Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy

Exclusion Criteria:

  • Known hypersensitivity to cyclosporine or propylene glycol (PG)
  • Females who are pregnant or are considering becoming pregnant
  • Females who are breast feeding a child.
  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: NCT00633373

Locations
United States, California
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida Health Sciences Center
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Clinic, Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
APT Pharmaceuticals, Inc.
  More Information

Publications:

Responsible Party: APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00633373     History of Changes
Other Study ID Numbers: ACS004
Study First Received: March 5, 2008
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by APT Pharmaceuticals, Inc.:
lung
transplant
transplant rejection
Cyclosporine
bronchiolitis obliterans
aerosol

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Pharmaceutical Solutions
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014