Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

This study compares the therapeutic (clinical and radiological) efficacy of a six-month treatment by itraconazole and nebulised Ambisome® (liposomal amphotericin B = LAmB) versus treatment by itraconazole alone, in non - or mildly - immunocompromised patients affected by Chronic Pulmonary Aspergillosis (single aspergilloma excluded). • Control arm: Itraconazole 200 mg x 2/day associated with inactive nebulised treatment twice a week during 24 weeks. • Experimental arm: Itraconazole 200 mg x 2/day associated with nebulised LAmB, at 25 mg twice a week during 24 weeks. Follow up duration for the patients will be 24 months (12 months minimum) after discontinuation of the treatment being studied.

NCT Number	NCT03656081
Lead Sponsor	Poitiers University Hospital
Conditions	Chronic Pulmonary Aspergillosis
Enrollment	224 participants
Start Date	2018-12-19
Primary Completion	2027-06 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-20