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Not yet recruiting NCT07530263

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

Phase I Interventional Chronic Pulmonary Aspergillosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B, SPECT/CT scan.
Who it may be relevant to
Registry conditions: Chronic Pulmonary Aspergillosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug 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
  • Drug 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.
  • Radiation SPECT/CT scan
    After both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization

Primary outcome measures

  • The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT). [Time frame: 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. [Time frame: 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 [Time frame: Measured at day 1 (study day 1) and at dat 14 (study day 2) after nebulisation]
Secondary outcome measures (2)
  • Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs. [Time frame: 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. [Time frame: Measured at day 1 (study visit 1) and at dat 14 (study visit 2) after nebulisation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Radboudumc — Nijmegen

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗