Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)

Официальное название

Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 12 mg of nebulised 99mTc-liposomal amphotericin B
  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
• Препарат 24 mg of nebulised 99mTc-liposomal amphotericin B
  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.
• Лучевая терапия SPECT/CT scan
  After both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization

Первичные конечные точки

• The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT). [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation]

Вторичные конечные точки (2)

• Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs. [Срок оценки: 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. [Срок оценки: Measured at day 1 (study visit 1) and at dat 14 (study visit 2) after nebulisation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Radboudumc — Nijmegen

Идентификаторы

NCT: NCT07530263 · R0040621A · 2025-521770-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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