While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
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Parallel
Prednisone tablet and Itraconazole
DrugOral prednisolone 0.5 mg/Kg body weight tapered over 4 months and oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. traconazole will be given for 12 months
Oral itraconazole
DrugOral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. Itraconazole will be given for 12 months
Favourable response at six months after the randomization
Proportion of subjects with an overall favourable response at six months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease
Overall favourable response at 12 months after randomization
Proportion of subjects with an overall favourable response at 12 months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease
frequency of relapses at 18-months after randomization
Relapse: will be defined as persistent worsening of symptoms (for 14 days or more) as measured by VAS and radiological worsening. The subjects will be investigated for other causes of worsening such as bacterial infection or reinfection/reactivation of tuberculosis before labelling the worsening due to relapse of CPA. A relapse will be defined as an event that occurs 3 months after stopping treatment
adverse events in either arm
Adverse events due to systemic glucocorticoids and oral itraconazole will be assessed at 2 weeks after treatment initiation and then at 3 months interval till treatment completion
Serum total IgE response to treatment
proportion of subjects with 25% reduction in serum IgE at 6 weeks after treatment initiation
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