Nebulised lIposomal aMphotericin B in chronic pUlmonary aSpergillosis: a deposition study
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The amount of AmBisome deposited in the lungs measured through single-photon emission computed tomography (SPECT/CT).
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 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.
The most appropriate dose of nebulised AmBisome based on pulmonary deposition and pharmacokinetics.
Secondary Outcomes
- 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.
Investigators
Laura Michon
Scientific
Radboud universitair medisch centrum Stichting