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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521770-34-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
Prior to participant administration, a Good Manufacturing Practice (GMP)-compliant radiolabelling procedure for technetium-99m-labelled liposomal amphotericin B (99mTc-liposomal amphotericin B) will be developed and validated for clinical use in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome |
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| Arm B | Experimental | First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 mg of nebulised 99mTc-liposomal amphotericin B | Drug | All 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT). | Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation | |
| The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution. | Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation | |
| The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics | Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs. | All SAEs and SUSARs occurring within 72 hours after administration of 99mTc-liposomal amphotericin B will be reported | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura A Michon, MSc | Contact | +3124 361 1111 | laura.michon@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Netherlands |
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| 24 mg of nebulised 99mTc-liposomal amphotericin B | Drug | All 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. |
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| SPECT/CT scan | Radiation | After both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization |
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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. |
| Measured at day 1 (study visit 1) and at dat 14 (study visit 2) after nebulisation |