Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)|
- To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).
- 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.
|Study Start Date:||September 2004|
|Study Completion Date:||September 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177684
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Director:||Mark Ludwig||Enzon Pharmaceuticals, Inc.|