Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
Condition: Lung Transplantation; Fungal Infections
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 3

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
    

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.
    

Intervention name(s): Amphotericin B
Intervention type(s): Drug
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention