Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Transplantation; Fungal Infections
Intervention: Amphotericin B (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Mark Ludwig, Study Director, Affiliation: Enzon Pharmaceuticals, Inc.
Summary
The purpose of this study is to determine the optimal delivery system for the nebulization of
the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive
for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to
determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and
serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®)
(QD) via aerosolized nebulization
Clinical Details
Official title: Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).
Secondary outcome: To determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of a four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization in lung transplant recipients.
Detailed description:
Subject's visit for teaching and administration of the first dose of aerosolized liposomal
Amphotericin will be performed at the specified intervals before the scheduled bronchoscopy.
Subject will receive first dose of the aerosolized liposomal amphotericin under direct
supervision of physician and study coordinator. This visit will last approximately 2 hours.
Subject's spirometry will be performed before (standard of care) and after the administration
(research related) of first dose aerosolized liposomal amphotericin. Each spirometry
measurement takes approximately 1 hour. Prior to administration, blood pressure and heart
rate will be obtained.
In the absence of any significant side effect of the aerosolized liposomal amphotericin
(e. g., wheezing, shortness of breath, drop in FEV1 > 15%, the remaining three doses will be
dispensed to the patient through pharmacy. The subject will be instructed on how to measure
his/her peak flow rate before and after taking the aerosolized liposomal amphotericin.
(approximately 1 hour) A 24 hr study pager number will be given to subjects to contact the
investigators in case of development of side effects such as shortness of breath, wheezing,
heaviness in the chest.
The study coordinator will contact the subject daily to ensure the compliance with the
aerosolized liposomal amphotericin administration and monitor any untoward effects. This
phone contact will not take longer than 10 minutes of the participant's time.
Drug administration: Subjects will be dispensed vials of ABELCET ® and will be taught by the
study coordinator/investigators to draw drug from the vial to nebulizer. Detailed written
instructions will also be provided to the subjects. In addition subjects will prove the
comprehension of the instructions by demonstrating the procedure, to the study coordinator
during initial visit. The description for the patient is as follows "Before administering the
drug via nebulization, shake the vial gently until there is no evidence of any yellow
sediment at the bottom. Withdraw the appropriate dose of ABELCET ® from the required number
of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from
each syringe filled with ABELCET ® and replace with the 5-micron filter needle supplied with
each vial. Put no more than 7 ml of ABELCET ® in the nebulizer and inhaled over a period of
15 minutes. Continue the inhalation process until whole the amount is used up. Repeat the
procedure with additional drug if your doctor has prescribed more drug for you". Aero Eclipse
Nebulizer and Devilbliss 8650D compressor will be used for the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female lung transplant recipients at University of Pittsburgh Medical Center
≥ 18yrs of age will be eligible for the study. Subjects HIV status will not determine
the exclusion from study.
Exclusion Criteria:
- Pregnant women or women who are currently breast-feeding an infant
- Hypersensitive to amphotericin deoxycholate or lipid complex amphotericin B (Abelcet
®)
- Have a documented fungal infection
- Receipt of inhalational or IV amphotericin B within last 30 days
- Have a Temp ≥ 38ºC
- Hypoxemic (pulse oximeter < 92% at room air.)
- On mechanical ventilator
Locations and Contacts
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: September 2004
Ending date: September 2005
Last updated: August 31, 2007
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