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

NCT07530263 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2027-06-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530263 on ClinicalTrials.gov