RecruitingPhase 3NCT03656081

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)


Sponsor

Poitiers University Hospital

Enrollment

224 participants

Start Date

Dec 19, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Itraconazole, a drug called inhaled Ambisome®, and others for people with chronic pulmonary aspergillosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGinhaled Ambisome®

inhaled liposomal amphotericin B = inhaled LAmB

DRUGinhaled placebo

inhaled isotonic saline

DRUGItraconazole

Itraconazole tablet


Locations(1)

CHU Poitiers

Poitiers, France

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NCT03656081


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