A Randomized Trial Comparing Prednisolone, Itraconazole, or Their Combination in Acute Allergic Bronchopulmonary Aspergillosis

What this Trial Is About

Researchers are evaluating treatments for acute allergic bronchopulmonary aspergillosis (ABPA), a condition complicating asthma. This trial aims to compare whether a combination of prednisolone and itraconazole reduces the rate of exacerbations within one year better than either prednisolone or itraconazole alone. The study follows 300 adults aged 18 years and older diagnosed with acute ABPA, assessing the impact of these treatments on disease flare-ups. Participants will be randomly assigned to one of three groups: prednisolone alone, itraconazole alone, or a combination of both. Prednisolone is given orally in a tapering dose over four months, and itraconazole is given orally twice daily for four months with dose adjustments based on blood levels. The combination group receives both treatments simultaneously for the same duration. Therapeutic drug monitoring for itraconazole is performed at two weeks and two months. During the study, participants undergo baseline tests including demographic, immune, and imaging assessments. Follow-up visits occur every two months initially, then every four months for a total of five visits after treatment completion. Researchers track asthma and ABPA exacerbations over 12 months as the primary outcome. Secondary outcomes include immune response, time to first exacerbation, weight gain, blood sugar changes, and liver function. The study also monitors safety and treatment effects throughout the trial period.

A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis