Overview
Sponsor-declared trial summary
Chronic pulmonary aspergillosis
To assess the pulmonary deposition of liposomal amphotericin B, administered via nebulisation as Technetium-99m labelled AmBisome, aiming to assess intrapulmonary distribution and to provide arguments to optimize treatment design.
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-09-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess the pulmonary deposition of liposomal amphotericin B, administered via nebulisation as Technetium-99m labelled AmBisome, aiming to assess intrapulmonary distribution and to provide arguments to optimize treatment design.
Secondary objectives 3
- To develop, prepare and validate a GMP-grade procedure for Technetium-99m labelled AmBisome.
- To analyse the safety and tolerability of nebulised AmBisome.
- To investigate patient reported outcomes (PROs) with regards to the benefit of inhalation therapy compared to conventional intravenous therapy.
Conditions and MedDRA coding
Chronic pulmonary aspergillosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 4
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
- The amount of AmBisome in the lungs compared to the blood concentrations to understand drug absorption and distribution
- The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics.
Secondary endpoints 3
- A validated GMP-grade procedure for Technetium-99m labelled AmBisome.
- Number of adverse reactions associated with nebulised AmBisome, including respiratory symptoms, effects on pulmonary function and (S)AEs.
- Assessment of PROs using a validated PRO instruments (TSQM) to assess side effects, treatment convenience and global satisfaction with therapy.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Technetium (99MTC) Pertechnetate
SUB20433 · Substance
- Active substance
- Technetium (99MTC) Pertechnetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INHALATION
- Max daily dose
- 55 MBq megabecquerel(s)
- Max total dose
- 110 MBq megabecquerel(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Technetium-99m is combined with AmBisome
AmBisome liposomale amfotericine B 50 mg, poeder voor oplossing voor infusie
PRD43233 · Product
- Active substance
- Amphotericin B
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INHALATION
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 36 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AA01 — AMPHOTERICIN B
- Marketing authorisation
- RVG 15610
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product is combined with Technetium-99m
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Laura Michon
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Laura Michon
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol NIMBUS V3 20250829 redacted_trackchanges | 3 |
| Recruitment arrangements (for publication) | K1 Recruitment procedure NIMBUS V1 20250603 | 1 |
| Subject information and informed consent form (for publication) | L1 PIF IC_NIMBUS_V3_20250829_clean | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_AmBisome | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Technegas | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Technetium99m | 1 |
| Synopsis of the protocol (for publication) | D1 NIMBUS protocol synopsis EN V2 20251508_clean | 2 |
| Synopsis of the protocol (for publication) | D1 NIMBUS protocol synopsis NL V2 20251508_clean | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-05 | Netherlands | Acceptable with conditions 2025-09-04
|
2025-09-04 |