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

NCT00235651 | Terminated Phase 3

• 1 other identifier: IRB# 0509013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Transplantation; Lung Diseases

Keywords

Lung transplant recipient

Outcome Measures

Primary Outcomes (1)

• to determine the dose of medication deposited in the lungs

Secondary Outcomes (1)

• to determine the regional distribution of the drug in the lungs

Interventions

Amphotericin B DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Single or double lung transplant recipients
• Age \> 18
• Willing to be available at the testing center
• Able to understand and complete informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Enzon Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Shahid Husain, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: October 1, 2005
• Study Completion: April 1, 2006
• Last Updated: December 17, 2008

Record last verified: 2008-12

Locations

US (1)