Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
NCT ID: NCT00177684
Last Updated: 2008-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2004-09-30
2005-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amphotericin B
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Enzon Pharmaceuticals, Inc.
INDUSTRY
University of Pittsburgh
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Ludwig
Role: STUDY_DIRECTOR
Enzon Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Husain S, Capitano B, Corcoran T, Studer SM, Crespo M, Johnson B, Pilewski JM, Shutt K, Pakstis DL, Zhang S, Carey ME, Paterson DL, McCurry KR, Venkataramanan R. Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. Transplantation. 2010 Dec 15;90(11):1215-9. doi: 10.1097/TP.0b013e3181f995ea.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB # 0407015
Identifier Type: -
Identifier Source: org_study_id