Chronic Pulmonary AspergillosisPhase 1NIMBUSNCT07530263
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
A Phase 1 study testing 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B and SPECT/CT scan in people with Chronic Pulmonary Aspergillosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- What is being tested?
- 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B and SPECT/CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Radboudumc
Nijmegen
Laura A Michon, MSc, +3124 361 1111, laura.michon@radboudumc.nl
About this study
Official title: Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study
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.
Read the 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.
- Conditions
- Chronic Pulmonary Aspergillosis
- Being tested
- 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B, SPECT/CT scan
- Keywords
- ambisome, liposomal amphotericin B, nebulization, chronic pulmonary aspergillosis, deposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mg of nebulised 99mTc-liposomal amphotericin BDrug
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 BDrug
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 scanRadiation
After both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Low dose AmB first | Experimental | First dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome Receives: Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B; Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B; Radiation: SPECT/CT scan |
| Arm B: High dose AmB first | Experimental | First dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome Receives: Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B; Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B; Radiation: SPECT/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
Measured: 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: 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: 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.
Measured: 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.
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.
Measured: Measured at day 1 (study visit 1) and at dat 14 (study visit 2) after nebulisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530263
- Sponsor's protocol ID
- R0040621A
- Other IDs
- 2025-521770-34-00, 2025
- Acronym
- NIMBUS
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulised lIposomal aMphotericin B in Chronic pUlmonary aSpergillosis: a Deposition Study
- ClinicalTrials.gov ID
- NCT07530263
- Acronym / sponsor ID
- NIMBUS / R0040621A
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- ambisome, liposomal amphotericin B, nebulization, chronic pulmonary aspergillosis, deposition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Low dose AmB first | Experimental | Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B, Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B, Radiation: SPECT/CT scanFirst dose 12 mg nebulised AmBisome, second dose 24 mg nebulised AmBisome |
| Arm B: High dose AmB first | Experimental | Drug: 12 mg of nebulised 99mTc-liposomal amphotericin B, Drug: 24 mg of nebulised 99mTc-liposomal amphotericin B, Radiation: SPECT/CT scanFirst dose 24 mg nebulised AmBisome, second dose 12 mg nebulised AmBisome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 mg of nebulised 99mTc-liposomal amphotericin BAll 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 | Arm A: Low dose AmB first, Arm B: High dose AmB first |
| 24 mg of nebulised 99mTc-liposomal amphotericin BAll 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. | Drug | Arm A: Low dose AmB first, Arm B: High dose AmB first |
| SPECT/CT scanAfter both nebulisation sessions, a SPECT/CT scan will determine 99mTc-liposomal amphotericin B localization | Radiation | Arm A: Low dose AmB first, Arm B: High dose AmB first |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pulmonary Aspergillosis
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
Active, not recruitingPhase 2
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
Chronic Pulmonary Aspergillosis
Active, not recruitingObservational study
Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis
Pulmonary Tuberculoses, Chronic Pulmonary Aspergillosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B and SPECT/CT scan in people with Chronic Pulmonary Aspergillosis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A Michon, MSc (+3124 361 1111, laura.michon@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.