Who is sponsoring NCT01254708?

NCT01254708 is sponsored by University Health Network, Toronto.

What condition does NCT01254708 study?

NCT01254708 studies Lung Transplant Recipient.

What drugs are being tested in NCT01254708?

Interventions: Ambisome ®, Regular standard of care medication.

What is the status of NCT01254708?

NCT01254708 is currently SUSPENDED.

Last reviewed 2011-10-18 · How we verify

A Pilot Study to Determine the Safety and Clinical Efficacy of Once-Weekly Inhaled AmBisome for the Prevention of Aspergillus Colonization in Lung Transplant Recipients

NCT01254708 Phase 2 SUSPENDED

Lung transplant recipients have the highest rate of Invasive Aspergillus (IA)infection among solid organ transplant recipients. The most important risk factor for the development of IA (which is associated with disease and death) is colonization of the organism in the respiratory tract. Azoles are used to prevent the development of IA. Puffers containing antifungal medication can be used to treat the lungs without the need to worry about the medication interactions \& side-effects in the blood. An example of this is the aerosolized amphotericin B. Its use is limited by the patients' tolerating this medication that may cause cough, nausea \& contraction of the air pathways. The lipid preparation is better tolerated and has longer dosing interval than inhaled amphotericin B. The investigators propose a pilot study to determine the long-term safety of inhaled AmBisome administration of drug and generate the preliminary data on the effectiveness of this drug to prevent aspergillus colonization.

Details

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	SUSPENDED
Enrolment	4
Start date	2012-01
Completion	2014-01

Conditions

Lung Transplant Recipient

Interventions

Ambisome ®
Regular standard of care medication

Primary outcomes

Pulmonary Function — Day 1 to 12 months
Assess pulmonary function measurements i.e. changes in FEV1 (Forced Expiratory Volume 1), changes in FVC (Forced Vital Capacity) while receiving inhaled liposomal amphotericn B.
Symptoms — Day 1 to 12months
Assess onset of symptoms including headache, dizziness and fatigue, fever, nausea, vomiting, wheezing, cough, shortness of breath, and taste preservation, while receiving inhaled liposomal amphotericin B
Renal or Hepatic dysfunction and Neutropenia — Day 1 to 12 months
Assess the development of renal or hepatic dysfunction and neutropenia by measuring serum creatinine liver enzymes and white blood cells

Countries

Canada