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Clinical trial of an amikacin liposome inhalation suspension-based regimen in patients with pulmonary mycobacterial infection
THE ENCORE TRIAL IS A PHASE IIIB STUDY TO EVALUATE THE EFFICACY OF ALIS AZITHROMYCIN (AZI) ETHAMBUTOL (ETH) COMPARED TO THE EMPTY LIPOSOME CONTROL (VLC) AZI ETH ON PATIENT-REPORTED RESPIRATORY SYMPTOMS AT MONTH 13. ALIS (AMIKACIN LIPOSOME INHALATION SUSPENSION) 590 MG OR PLACEBO (VLC) IS ADMINISTERED BY INHALATION VIA A NEBULIZER DEVICE (EFLOW®), ONCE DAILY. AZI 250 MG AND ETH 15 MG/KG TABLETS ARE TO BE TAKEN ORALLY ONCE DAILY. THE PURPOSE IS TO EVALUATE THE EFFECT AND SAFETY OF TREATMENT WITH INHALED LIPOSOMAL AMIKACIN SUSPENSION (ALIS) WHEN ADMINISTERED TO PATIENTS WHO HAVE A NEW DIAGNOSIS OF MNT LUNG INFECTION CAUSED BY MAC AND WHO HAVE NOT YET STARTED TREATMENT.
Technical Summary
- ENCORE - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ACTIVE TREATMENT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN AMIKACIN LIPOSOME INHALATION SUSPENSION (ALIS) BASED REGIMEN IN ADULT PATIENTS WITH NEWLY DIAGNOSED PULMONARY NONTUBERCULOUS MYCOBACTERIAL INFECTION (NTM) CAUSED BY MYCOBACTERIUM AVIUM COMPLEX (MAC).
- Code EudraCT: 2020-003079-16
- Protocol number: INS-416
- Promoter: Insmed Incorporated
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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