Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00755781
Other study ID # CIS001
Secondary ID
Status Completed
Phase Phase 3
First received September 17, 2008
Last updated September 13, 2012
Start date September 2008
Est. completion date November 2011

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
APT Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT03299504 - Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation
Recruiting NCT05547698 - A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation N/A
Terminated NCT03207399 - Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment Phase 4
Completed NCT03300882 - PREDICT Cytomegalovirus (CMV)
Recruiting NCT05101460 - An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Completed NCT03150095 - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates N/A
Completed NCT04420195 - Envarsus XR in Lung Transplant Phase 2
Recruiting NCT02235610 - Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation N/A
Not yet recruiting NCT06066229 - Identification of Patient Important Outcomes in Lung Transplantation
Recruiting NCT04601818 - Planned Semi-Elective Lung Tx Study N/A
Recruiting NCT03072589 - Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation Phase 1
Completed NCT01963780 - International EXPAND Lung Pivotal Trial N/A
Recruiting NCT05671887 - DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
Completed NCT03987113 - Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
Recruiting NCT02748798 - Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders Early Phase 1
Completed NCT03167528 - Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients N/A
Active, not recruiting NCT04244734 - Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home. N/A
Active, not recruiting NCT01365429 - Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs N/A
Recruiting NCT05055739 - Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant N/A