This study evaluates and aims to optimize inhalation treatment with nebulized liposomal amphotericin B in patients with chronic pulmonary aspergillosis. The primary objective is to assess the pulmonary deposition and intrapulmonary distribution of liposomal amphotericin B after nebulization, using technetium-99m-labeled liposomal amphotericin B and SPECT/CT imaging. The study also aims to generate data to inform optimization of inhalation treatment design.
Participants will receive two different doses of nebulized liposomal amphotericin B (12 mg and 24 mg) on separate study days. After each administration, participants will undergo SPECT/CT imaging to assess pulmonary deposition. Blood samples will be collected on both study days and after study treatment to evaluate safety and measure systemic amphotericin B concentrations. Participants will also perform spirometry using a handheld device and complete a treatment satisfaction questionnaire on both study days.
The patient is at least 18 years old on the day of inclusion.
The patients has been diagnosed with chronic pulmonary aspergillosis.
There is no significant interference with standard care and follow-up.
The patient is breastfeeding, or of childbearing potential and is pregnant, planning to become pregnant within 3 months of the SPECT imaging, unable to provide a negative pregnancy test at screening, or unwilling to use effective contraception during the study and for at least 3 months after the last SPECT scan.
The patient is not able to lie supine in the scanner.
The patient has previously reported intolerance to inhalation medication.
The patient is unable to provide informed consent due to lack of decision-making capacity.
Crossover
12 mg of nebulised 99mTc-liposomal amphotericin B
DrugAll enrolled subjects will receive nebulised liposomal amphotericin B in addition to standard care. Subjects will be randomly assigned to one of two dosage levels: 12 mg or 24 mg. As this study follows a crossover design, each participant will eventually receive both dosages. Each nebulisation session will have a duration of 10 to 20 minutes, separated by a 14-day washout period between the two sessions
24 mg of nebulised 99mTc-liposomal amphotericin B
DrugAll enrolled subjects will receive nebulised AmBisome in addition to standard care. Subjects will be randomly assigned to one of two dosage levels: 12 mg or 24 mg. As this study follows a crossover design, each participant will eventually receive both dosages. Each nebulisation session will have a duration of 10 to 20 minutes, separated by a 14-day washout period between the two sessions.
SPECT/CT scan
RadiationAfter both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization
The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution.
The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics
Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs.
Assessment of patient-reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM), a validated instrument, to assess side effects, treatment convenience and global satisfaction with therapy.
Patient-reported treatment satisfaction and tolerability of nebulised liposomal amphotericin B will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM), version 1.4, a validated patient-reported outcome instrument. The following three TSQM domain scores will be evaluated as part of this outcome measure: Side Effects, Convenience, and Global Satisfaction. Each domain score is transformed to a 0 to 100 scale, with higher scores indicating a better outcome. Specifically, for the Side Effects domain, higher scores indicate fewer or less bothersome side effects; for the Convenience domain, higher scores indicate greater treatment convenience; and for the Global Satisfaction domain, higher scores indicate greater overall satisfaction with therapy. There is no single total TSQM score for this outcome measure; results will be reported separately for each domain.
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Radboud University Medical Center
Lead sponsor
Gilead Sciences
Collaborator
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