Amphotericin B for Simple pulmonary aspergilloma

Inclusion criteria

• {"criterion_text":"- Diagnosis of (simple) pulmonary aspergilloma. Diagnosis of (simple) pulmonary aspergilloma is made in concordance with 2016 ESCMID/ERS guidelines for diagnosis and management of chronic pulmonary aspergillosis (Single pulmonary cavity containing a fungal ball, with serological or microbiological evidence implicating Aspergillus spp. in a non-immunocompromised patient with minor or no symptoms). The diagnosis is made based on the typical findings on chest CT scan (a rounded mass within a pre-existing pulmonary cavity, air crescent sign around the mass), combined with one of the following tests: •\tPositive Aspergillus Ag (Galactomannan) in bronchoalveolar lavage fluid and/or serum •\tAspergillus Spp. culture positive in BAL fluid •\tAspergillus-IgG antibody positive •\tOther diagnoses excluded - mainly pulmonary TB (sputum or BAL microscopy and cultures negative for M. tuberculosis)\n- Age 18 to 80 years\n- Surgical resection of aspergilloma not possible or not indicated, or the patient has refused surgical treatment\n- Systemic antifungal treatment not indicated or refused, or the patient has previously failed systemic antifungal treatment (currently not receiving)"}

Exclusion criteria

• {"criterion_text":"- Not signed informed consent, refusal to participate in the study\n- Coagulation abnormalities: •\tSevere thrombocytopenia < 30 x10 9/L •\tElevated INR > 2.50\n- Hypersensitivity to Amphotericin B class antifungal drugs\n- Systemic antifungal therapy indicated, or the patient is currently receiving such therapy\n- Surgical resection of pulmonary aspergilloma is indicated and is possible\n- Severe hemoptysis, requiring bronchial artery embolisation or surgical treatment\n- Pregnancy\n- More than 1 mycetoma on chest CT scan\n- Severe impairment in lung function, defined as FEV1 < 30 %\n- Contraindications to performing elective bronchoscopy: •\tHemodynamically unstable patients •\tHypoxaemia (SpO2 < 88% on room air) •\tPreviously known chronic type II respiratory failure (pCO2 > 45 mmHg on arterial blood gas analysis) •\tRecent myocardial infarction (< 3 months)"}

Primary endpoints

• {"endpoint_text":"- Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.","definition_or_measurement_approach":"Measured as percentage change from baseline lesion (aspergilloma) size to post-treatment lesion size."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients in each treatment response category based on changes in aspergilloma (mycetoma) size from baseline to Week 8 visit, categorized as complete response (complete absorption of the lesion, 100% reduction in size), partial response (≥ 50% reduction in lesion size) and insufficient response (< 50% reduction or no change in lesion size).","definition_or_measurement_approach":"Response categories defined by percent reduction in lesion size from baseline to Week 8: complete = 100% reduction; partial = ≥50% reduction; insufficient = <50% reduction or no change."}
• {"endpoint_text":"- Proportion of patients with adverse events categorized by severity as mild, moderate or severe during treatment with intrabronchial instillation of liposomal Amphotericin B.","definition_or_measurement_approach":"Adverse events recorded and categorized by severity (mild, moderate, severe) during treatment."}
• {"endpoint_text":"- The proportion of patients with change shift on the COPD Assessment Test (CAT) score from baseline to post-treatment assessment visit.","definition_or_measurement_approach":"Change in CAT score from baseline to post-treatment assessment; proportion of patients with a shift in CAT score."}
• {"endpoint_text":"- The proportion of patients with disease progression during study treatment, defined as an increase in the size of aspergilloma (mycetoma) or progression to other forms of chronic pulmonary aspergillosis – chronic cavitary or fibrosing pulmonary aspergillosis, invasive pulmonary aspergillosis.","definition_or_measurement_approach":"Disease progression defined as increase in aspergilloma size or progression to other chronic pulmonary aspergillosis forms (chronic cavitary, fibrosing, invasive)."}
• {"endpoint_text":"- Proportion of patients with hemoptysis during study treatment, categorized by severity as mild, moderate and severe.","definition_or_measurement_approach":"Hemoptysis events recorded and categorized by severity (mild, moderate, severe) during study treatment."}

Latvia

Earliest CTIS Part Ii Submission Date

17-01-2026

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

55

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Pauls Stradins Clinical University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Latvia