Comparing Six-Month Treatment of Itraconazole With or Without Nebulised Ambisome for Adults With Chronic Pulmonary Aspergillosis

What this Trial Is About

Researchers are comparing the effects of two treatments for Chronic Pulmonary Aspergillosis CPA in adults who are not or only mildly immunocompromised. The study evaluates the clinical and radiological outcomes of a six-month therapy combining itraconazole with nebulised Ambisome4 liposomal amphotericin B against itraconazole alone. Patients with single aspergilloma are excluded from this study, which is a prospective, randomized, single-blind phase 3 trial sponsored by Poitiers University Hospital. Participants are assigned to one of two groups the control group receives itraconazole 200 mg twice daily plus an inactive nebulised treatment isotonic saline twice weekly for 24 weeks, while the experimental group receives the same itraconazole dose combined with inhaled liposomal amphotericin B at 25 mg twice weekly for 24 weeks. The study includes a 24-month follow-up period after treatment ends, with a minimum follow-up of 12 months. During the study, participants will undergo clinical and radiological assessments to measure improvement or stability after six months of treatment. Additional evaluations include monitoring major events, relapse rates, and mycological response over 30 months. The primary outcome focuses on a composite measure of clinical and radiological improvement at six months. Safety and treatment adherence will be closely monitored throughout the study period.

Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole