A Phase 2, monocentric, prospective, nonrandomized, open-label, experimental study to evaluate efficacy and safety of intrabronchial instillation of liposomal Amphotericin B in patients with simple pulmonary aspergilloma.

Conditions

Simple aspergilloma

Brief summary

Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.

Detailed description

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)., Proportion of patients with adverse events categorized by severity as mild, moderate or severe during treatment with intrabronchial instillation of liposomal Amphotericin B., The proportion of patients with change shift on the COPD Assessment Test (CAT) score from baseline to post-treatment assessment visit., 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., Proportion of patients with hemoptysis during study treatment, categorized by severity as mild, moderate and severe.

Related papers

No related papers found yet.

Interventions

DRUGAmBisome liposomāls amfotericīns B 50 mg pulveris infūziju šķīduma pagatavošanai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.	—

Secondary

Measure	Time frame
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)., Proportion of patients with adverse events categorized by severity as mild, moderate or severe during treatment with intrabronchial instillation of liposomal Amphotericin B., The proportion of patients with change shift on the COPD Assessment Test (CAT) score from baseline to post-treatment assessment visit., 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., Proportion of patients with hemop	—

Measure

Time frame

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)., Proportion of patients with adverse events categorized by severity as mild, moderate or severe during treatment with intrabronchial instillation of liposomal Amphotericin B., The proportion of patients with change shift on the COPD Assessment Test (CAT) score from baseline to post-treatment assessment visit., 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., Proportion of patients with hemop

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Outcome results

None listed