Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07530263

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Pulmonary Aspergillosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

SPECT/CT scan

Radiation

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

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

    Patient-reported treatment satisfaction and tolerability of nebulised liposomal amphotericin B will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM), version 1.4, a validated patient-reported outcome instrument. The following three TSQM domain scores will be evaluated as part of this outcome measure: Side Effects, Convenience, and Global Satisfaction. Each domain score is transformed to a 0 to 100 scale, with higher scores indicating a better outcome. Specifically, for the Side Effects domain, higher scores indicate fewer or less bothersome side effects; for the Convenience domain, higher scores indicate greater treatment convenience; and for the Global Satisfaction domain, higher scores indicate greater overall satisfaction with therapy. There is no single total TSQM score for this outcome measure; results will be reported separately for each domain.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura A Michon, MSc

CONTACT

[email protected]

+3124 361 1111

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: NIMBUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.