Lung Transplant Clinical Trial
— CIS001Official 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
Verified date | September 2012 |
Source | APT Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 284 |
Est. completion date | November 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto | Toronto | Ontario |
United States | University of Maryland | Baltimore | Maryland |
United States | University of Chicago Hospitals | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Colorado Health Sciences Center | Denver | Colorado |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | University of Florida Health Sciences Center | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana Methodist Research Institute | Indianapolis | Indiana |
United States | Mayo Clinic | Jacksonville | Florida |
United States | UCLA School of Medicine | Los Angeles | California |
United States | Loyola University Hospital | Maywood | Illinois |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | New York Presbyterian Hospital, Columbia University Med. Ctr. | New York | New York |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
United States | Stanford University Medical Center | Stanford | California |
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
APT Pharmaceuticals, Inc. |
United States, Canada,
Burkart GJ, Smaldone GC, Eldon MA, Venkataramanan R, Dauber J, Zeevi A, McCurry K, McKaveney TP, Corcoran TE, Griffith BP, Iacono AT. Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res. 2003 Feb;20(2):252-6. — View Citation
Iacono A, Dauber J, Keenan R, Spichty K, Cai J, Grgurich W, Burckart G, Smaldone G, Pham S, Ohori NP, Yousem S, Williams P, Griffith B, Zeevi A. Interleukin 6 and interferon-gamma gene expression in lung transplant recipients with refractory acute cellular rejection: implications for monitoring and inhibition by treatment with aerosolized cyclosporine. Transplantation. 1997 Jul 27;64(2):263-9. — View Citation
Iacono AT, Corcoran TE, Griffith BP, Grgurich WF, Smith DA, Zeevi A, Smaldone GC, McCurry KR, Johnson BA, Dauber JH. Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans. Eur Respir J. 2004 Mar;23(3):384-90. — View Citation
Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. — View Citation
Iacono AT, Keenan RJ, Duncan SR, Smaldone GC, Dauber JH, Paradis IL, Ohori NP, Grgurich WF, Burckart GJ, Zeevi A, Delgado E, O'Riordan TG, Zendarsky MM, Yousem SA, Griffith BP. Aerosolized cyclosporine in lung recipients with refractory chronic rejection. Am J Respir Crit Care Med. 1996 Apr;153(4 Pt 1):1451-5. — View Citation
Iacono AT, Smaldone GC, Keenan RJ, Diot P, Dauber JH, Zeevi A, Burckart GJ, Griffith BP. Dose-related reversal of acute lung rejection by aerosolized cyclosporine. Am J Respir Crit Care Med. 1997 May;155(5):1690-8. — View Citation
Keenan RJ, Iacono A, Dauber JH, Zeevi A, Yousem SA, Ohori NP, Burckart GJ, Kawai A, Smaldone GC, Griffith BP. Treatment of refractory acute allograft rejection with aerosolized cyclosporine in lung transplant recipients. J Thorac Cardiovasc Surg. 1997 Feb;113(2):335-40; discussion 340-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessed when symptoms of syndrome present | No | |
Secondary | Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization | From study initiation through 2+ years after randomization | No | |
Secondary | All cause mortality | From study initiation through 2+ years after randomization | No | |
Secondary | 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) | From study initiation through 2+ year after randomzation | No |
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