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

NCT07530263 | Not Yet Recruiting Phase 1

• 2 other identifiers: R0040621A2025-521770-34-00
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pulmonary Aspergillosis

Keywords

ambisome; liposomal amphotericin B; nebulization; chronic pulmonary aspergillosis; deposition

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome

Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B; Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B; Radiation: SPECT/CT scan

Arm B

EXPERIMENTAL

First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome

Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B; Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B; Radiation: SPECT/CT scan

Interventions

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

Arm A; Arm B

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.

Arm A; Arm B

SPECT/CT scan RADIATION

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

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients has been diagnosed with chronic pulmonary aspergillosis.
• There is no significant interference with standard care and follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Central Study Contacts

Laura A Michon, MSc

CONTACT

+3124 361 1111; laura.michon@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)