NCT03656081

Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

Therapeutic Efficacy Comparison of a Six-month Treatment by Itraconazole and Nebulised Ambisome® Versus Treatment by Itraconazole Alone in Non- or Mildly- Immunocompromised Patients with Chronic Pulmonary Aspergillosis: a Prospective, Randomized, Single Blind Study, (single Aspergilloma Excluded)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	inhaled Ambisome®	inhaled liposomal amphotericin B = inhaled LAmB
DRUG	inhaled placebo	inhaled isotonic saline
DRUG	Itraconazole	Itraconazole tablet

Timeline

• Start date: 2018-12-19
• Primary completion: 2027-06-01
• Completion: 2029-12-01
• First posted: 2018-09-04
• Last updated: 2025-02-20

Locations

1 site across 1 country: France