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

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ClinicalTrials.gov Identifier: NCT00235651
Recruitment Status : Terminated (study completed)
First Posted : October 10, 2005
Last Update Posted : December 17, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Completion Date : April 2006

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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

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.
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00235651


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

ClinicalTrials.gov 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:
Lung Diseases
Respiratory Tract Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents