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Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole

NCT03656081 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-02-20

No results posted yet for this study

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

DRUG

inhaled Ambisome®

inhaled liposomal amphotericin B = inhaled LAmB

DRUG

inhaled placebo

inhaled isotonic saline

DRUG

Itraconazole

Itraconazole tablet

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Cendrine GODET, MD · Bichat Hospital, AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2027-06-30
Completion
2029-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656081 on ClinicalTrials.gov