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Be Part of Research - Trial Details - Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Infections
Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Mycobacterium Infections, Nontuberculous


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2021 Nov 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Inhalation via nebulization over approximately 6 to 15 minutes

Intervention Arm Group : ALIS + Background Regimen;

Intervention Type : DRUG
Intervention Description : Oral tablet

Intervention Arm Group : ALIS + Background Regimen;ELC + Background Regimen;

Intervention Type : DRUG
Intervention Description : Oral tablet

Intervention Arm Group : ALIS + Background Regimen;ELC + Background Regimen;

Intervention Type : DRUG
Intervention Description : Inhalation via nebulization over approximately 6 to 15 minutes

Intervention Arm Group : ELC + Background Regimen;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GBR009
    Plymouth
    Devon
    PL6 8BQ
  • GBR012
    Salford
    Lancashire
    M6 8HD
  • GBR013
    Swansea
    West Glamorgan
    SA6 6NL
  • GBR008
    Birmingham
    West Midlands
    B9 5SS
  • GBR005
    Aberdeen
    AB25 2ZN
  • GBR001
    Cambridge
    CB2 OAY
  • GBR002
    Dundee
    DD1 9SY
  • GBR004
    Liverpool
    L14 3PE
  • GBR007
    London
    EC1A 7BE
  • GBR010
    London
    NW32QG
  • GBR003
    London
    SW3 6NP


The study is sponsored by Insmed Incorporated




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Read full details for Trial ID: NCT04677569
Last updated 22 April 2025

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