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NCT07530263
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Conditions: Chronic Pulmonary Aspergillosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Radboud University Medical Center
Location: Radboudumc Nijmegen
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07530263). StuddyBuddy aggregates publicly available trial information.