Comparing Oral Itraconazole Alone to Combination with Systemic Glucocorticoids for Overlap of Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis

What this Trial Is About

Researchers are studying the overlap syndrome of allergic bronchopulmonary aspergillosis ABPA and chronic pulmonary aspergillosis CPA, two distinct lung diseases caused by Aspergillus infection that sometimes occur together. This trial aims to compare the clinical outcomes of patients with ABPA-CPA overlap treated with either oral itraconazole alone or a combination of systemic glucocorticoids and oral itraconazole. The study explores whether combining treatments may better address the complex immune responses in this overlap condition. The study involves two treatment groups. One group receives oral itraconazole 400 mgday for 12 months, with dose adjustments based on blood levels. The other group receives a combination of oral prednisolone 0.5 mgkg body weight tapered over 4 months plus oral itraconazole for 12 months. The goal is to evaluate how these treatments affect the patients condition over time and to assess the safety and relapse rates. Participants will be monitored through clinical evaluations, imaging studies, and laboratory testing including immunological markers like total IgE and Aspergillus-specific antibodies. Outcomes such as favorable response at 6 months, overall response at 12 months, relapse frequency at 18 months, and adverse events will be recorded. The study includes ongoing assessments of serum IgE during treatment and relapse, with a total participation period extending up to 18 months after randomization.

Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome