Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00177684
Other study ID # IRB # 0407015
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated December 16, 2008
Start date September 2004
Est. completion date September 2005

Study information

Verified date December 2008
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Amphotericin B


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).
Secondary 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.
See also
  Status Clinical Trial Phase
Completed NCT02581111 - Naloxone for Optimizing Hypoxemia Of Lung Donors Phase 2/Phase 3
Recruiting NCT02177916 - Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation N/A
Not yet recruiting NCT01394835 - Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients Phase 2
Not yet recruiting NCT01162148 - Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation N/A
Completed NCT01204970 - Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients N/A
Active, not recruiting NCT00980967 - Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Recruiting NCT00163696 - Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease N/A
Completed NCT00163891 - Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients N/A
Completed NCT03668483 - Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx N/A
Not yet recruiting NCT02855372 - Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT) N/A
Completed NCT01211509 - Montelukast in Bronchiolitis Obliterans Syndrome Phase 4
Completed NCT01212406 - Vitamin D in Bronchiolitis Obliterans Syndrome Phase 4
Not yet recruiting NCT00808600 - Empowerment of Lung and Heart-lung Transplant Patients N/A
Completed NCT00553397 - Live Lung Donor Retrospective Study N/A
Completed NCT00402805 - Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy Phase 4
Completed NCT00701922 - Surveillance Study of Viral Infections Following Lung Transplantation N/A
Terminated NCT00235651 - Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients Phase 3
Active, not recruiting NCT02936505 - Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD. N/A
Recruiting NCT03798860 - Monitoring of Donor-specific Antibodies After Treatment With Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation