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Parent study CIS001 was completed
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This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled cyclosporine | Other | Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine Inhalation Solution (CIS) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety of CIS administration | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A Johnson, MD | University of Pittsburgh | Principal Investigator |
| Jeffrey Golden, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine | Los Angeles | California | 90095 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12636164 | Background | 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. doi: 10.1023/a:1022275222207. | |
| 9154878 | Background |
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| San Francisco |
| California |
| 94143 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Colorado Health Sciences Cente | Denver | Colorado | 80262 | United States |
| University of Florida Health Sciences Center | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33601 | United States |
| Loyola University Hospital | Maywood | Illinois | 60153 | United States |
| Indiana Methodist Research Institute | Indianapolis | Indiana | 46202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| New York Presbyterian Hospital, Columbia University Med. Ctr. | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22402 | United States |
| University of Toronto | Toronto | Ontario | M5G 2N2 | Canada |
| 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. doi: 10.1164/ajrccm.155.5.9154878. |
| 9040628 | Background | 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. doi: 10.1016/S0022-5223(97)70331-3. |
| 9256185 | Background | 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. doi: 10.1097/00007890-199707270-00015. |
| 16407509 | Background | 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. doi: 10.1056/NEJMoa043204. |
| 15065826 | Background | 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. doi: 10.1183/09031936.04.00058504. |
| 8616581 | Background | 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. doi: 10.1164/ajrccm.153.4.8616581. |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D001989 | Bronchiolitis Obliterans |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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