Comparing Nebulized Amphotericin B to Normal Saline as Maintenance Therapy to Delay Relapse in Adults With Chronic Pulmonary Aspergillosis After 12 Months of Oral Itraconazole

What this Trial Is About

Chronic Pulmonary Aspergillosis CPA is a serious lung disease caused by the fungus Aspergillus, primarily affecting people with damaged lungs such as those recovering from tuberculosis. CPA has a high mortality rate and is often misdiagnosed as tuberculosis, leading to delays in proper antifungal treatment. This trial aims to evaluate the use of nebulized amphotericin B as maintenance therapy to reduce relapse and prolong time to relapse in CPA patients who have completed 12 months of oral itraconazole treatment. Participants will be randomly assigned to receive either nebulized amphotericin B deoxycholate twice daily or nebulized normal saline as a placebo. The amphotericin B is prepared by mixing a specific dose with distilled water to ensure full nebulization. The study compares these two inhalation treatments to see which better maintains health after initial oral antifungal therapy, with treatments continuing as maintenance following 12 months of oral itraconazole. Throughout the 12 months following randomization, participants will be closely monitored for time to first exacerbation, frequency of relapses, and any treatment-related side effects. Assessments include clinical evaluations and safety monitoring to determine the effects of the nebulized treatments as maintenance therapy. This trial will help understand the potential benefits and safety of inhaled amphotericin B in managing CPA over a year-long period.

A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis