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Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235651
Recruitment Status : Terminated (study completed)
First Posted : October 10, 2005
Last Update Posted : December 17, 2008
Enzon Pharmaceuticals, Inc.
Information provided by:
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Transplantation Lung Diseases Drug: Amphotericin B Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Deposition Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet®) in Lung Transplant Recipients (Radiotagging Protocol)
Study Start Date : October 2005
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. to determine the dose of medication deposited in the lungs

Secondary Outcome Measures :
  1. to determine the regional distribution of the drug in the lungs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Single or double lung transplant recipients
  2. Age > 18
  3. Willing to be available at the testing center
  4. Able to understand and complete informed consent

Exclusion Criteria:

  1. Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.
  2. Nursing mothers.
  3. Hypersensitivity to amphotericin B (Abelcet®) or technetium [Tc-99m] based radiopharmaceuticals.
  4. Subjects with a past history of bronchospasm associated with aerosol drug use
  5. Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
  6. Subjects with an FEV1 < 30% predicted or forced vital capacity (FVC) % predicted < 30%
  7. Subjects requiring supplemental oxygen
  8. Receipt of inhalational or IV amphotericin B within last 30 days
  9. Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
  10. Serum creatinine > 1.9 mg/dl on the day of clinic visit
  11. Liver enzymes ALT/AST/alk phos greater than two times the normal limit
  12. Concurrent intravenous aminoglycoside use
  13. Subjects with fever > 38.2°C
  14. Subjects on mechanical ventilation.
  15. Have participated in any studies involving radiopharmaceuticals within 14 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235651

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Enzon Pharmaceuticals, Inc.
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Principal Investigator: Shahid Husain, MD University of Pittsburgh

Layout table for additonal information Identifier: NCT00235651     History of Changes
Other Study ID Numbers: IRB# 0509013
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008
Keywords provided by University of Pittsburgh:
Lung transplant recipient
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents