Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the steady state concentrations of inhaled liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized nebulization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• Male and female lung transplant recipients at University of Pittsburgh Medical Center ≥ 18 years of age will be eligible for the study.

• Single or double lung transplant recipients

• Willing to be available at the testing center for 4 consecutive days

• Able to comprehend and complete informed consent

Exclusion Criteria:

• Pregnant women or women capable of bearing children, who will not perform a urine pregnancy test

• Nursing mothers

• Subjects with hypersensitivity to amphotericin deoxycholate or liposomal amphotericin

• 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 a forced expiratory volume in 1 second (FEV1) < 30% predicted or forced vital capacity (FVC) < 30% will not receive study medication.

• Subjects requiring supplemental oxygen

• Receipt of inhalational or intravenous (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 screening

• Liver enzymes ALT/AST/alkaline phosphatase greater than two times the normal limit

• Concurrent intravenous aminoglycoside use

• Subject with fever > 38.2°C

• Subjects on mechanical ventilation