The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy.
In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.
newly diagnosed subjects with uncontrolled asthma or symptoms or radiology suggesting active lesions attributable to ABPA and meeting the diagnostic criteria of ABPA
those previously meeting the diagnostic criteria for ABPA and presenting with sustained (≥2 weeks) clinical or radiological worsening; and increase in serum total IgE by ≥50% of the last recorded IgE value during clinical stability.
occurrence of ≥3 ABPA exacerbations in the last 18 months before enrollment
contraindications to the use of either prednisolone or itraconazole
subjects who have received oral prednisolone (or equivalent) ≥30 mg for ≥2 weeks or itraconazole (or voriconazole or posaconazole or isavuconazole) for more than 2 weeks, in the last 3 months
chronic medical illnesses, including uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure, chronic heart failure, and others
Parallel
Prednisolone
DrugPrednisolone for 4 months
Itraconazole
DrugSUBA-itraconazole for 4 months
Asthma or ABPA exacerbations
Proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion
Composite response
Proportion of subjects experiencing composite response defined as symptomatic improvement by at least 50%; and, major radiological improvement, and a decline in serum total IgE by at least 20% of baseline
IgE decline
Percentage decline in IgE (baseline IgE minus IgE after eight weeks/baseline IgE
Time to first ABPA exacerbation
Time to first ABPA exacerbation in days
Time to first asthma exacerbation
Time to first asthma exacerbation in days
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