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Sponsors and Collaborators: |
University of Pittsburgh Enzon Pharmaceuticals, Inc. |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00235651 |
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized Abelcet® (lipid complexed amphotericin-B). This study is being performed to determine the range of deposited doses and patterns of distribution that could be expected in this population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope technique will be utilized to track the medication dose. The study will include 12 subjects who will perform one testing session lasting approximately 3 hours. An Investigational New Drug Application (IND) detailing this protocol has been submitted by the principal investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).
Condition | Intervention | Phase |
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Lung Transplantation Lung Diseases |
Drug: Amphotericin B |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Bio-availability Study |
Official Title: | Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol) |
Estimated Enrollment: | 12 |
Study Start Date: | October 2005 |
Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Shahid Husain, MD | University of Pittsburgh |
Study ID Numbers: | IRB# 0509013 |
Study First Received: | October 6, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00235651 |
Health Authority: | United States: Food and Drug Administration |
Lung transplant recipient |
Abelcet Amphotericin B Respiratory Tract Diseases Clotrimazole |
Miconazole Lung Diseases Tioconazole Liposomal amphotericin B |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Antifungal Agents |
Therapeutic Uses Antibiotics, Antifungal Amebicides Pharmacologic Actions |