ENCORE – Study of an ALIS based regimen in Adults with MAC Lung Infection
Research type
Research Study
Full title
ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
IRAS ID
1004406
Contact name
Diane Fiorenza
Contact email
Sponsor organisation
Insmed Incorporated
Eudract number
2020-003079-16
ISRCTN Number
ISRCTN15403905
Clinicaltrials.gov Identifier
Research summary
This is a randomised, double-blind, placebo-controlled, active comparator study in patients with a new diagnosis of MAC (Mycobacterium avium complex) lung infection who have not started treatment for their current infection.
MAC lung disease is a serious condition. If untreated, it can cause damage to the lungs. There is a need for effective treatment options for this disease.
The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS, study drug) treatment on patient reported symptoms.
Participants will be selected by chance to receive one of the following treatment groups:
•ALIS + azithromycin (AZI) and ethambutol (ETH) or
•Empty liposome control (ELC) (also called a placebo) + AZI and ETH
A placebo is an inactive substance that looks like the study treatment but contains no medication.
Study procedures include physical examination, vital signs, blood and urine sampling, lung function tests, electrocardiogram (ECG), hearing test, sputum (a mixture of saliva and mucus coughed up from the respiratory tract), questionnaires and various other assessments.
The study will last up to 17.5 months and is planned to include approximately 250 participants.
This study is sponsored by Insmed Incorporated.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0033
Date of REC Opinion
6 Apr 2022
REC opinion
Further Information Favourable Opinion