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RECRUITING
NCT03656081
PHASE3

Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2018-12-19

Completion Date

2029-12

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

DRUG

inhaled Ambisome®

inhaled liposomal amphotericin B = inhaled LAmB

DRUG

inhaled placebo

inhaled isotonic saline

DRUG

Itraconazole

Itraconazole tablet

Locations (1)

CHU Poitiers

Poitiers, France