Status:
COMPLETED
Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
Lead Sponsor:
APT Pharmaceuticals, Inc.
Conditions:
Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 obli...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00755781
Start Date
September 1 2008
End Date
November 1 2011
Last Update
September 17 2012
Active Locations (19)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262