A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh