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Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633373
First Posted: March 12, 2008
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
APT Pharmaceuticals, Inc.
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 5, 2008
First Posted: March 12, 2008
Last Update Posted: September 17, 2012
Last Verified: September 2012

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

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