Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

Summary

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.

Timeline

Start

2018-12-19

Primary completion

2027-06

Completion

2029-12

Drugs

Indications