Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A: Low dose AmB first
First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome
干预措施: 12 mg of nebulised 99mTc-liposomal amphotericin B (Drug)
Arm A: Low dose AmB first
First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome
干预措施: 24 mg of nebulised 99mTc-liposomal amphotericin B (Drug)
Arm A: Low dose AmB first
First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome
干预措施: SPECT/CT scan (Radiation)
Arm B: High dose AmB first
First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome
干预措施: 12 mg of nebulised 99mTc-liposomal amphotericin B (Drug)
Arm B: High dose AmB first
First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome
干预措施: 24 mg of nebulised 99mTc-liposomal amphotericin B (Drug)
Arm B: High dose AmB first
First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome
干预措施: SPECT/CT scan (Radiation)
结局指标
主要结局
The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics
时间窗: Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation
The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
时间窗: 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.
时间窗: Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation
次要结局
- 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.(Measured at day 1 (study visit 1) and at dat 14 (study visit 2) after nebulisation)