Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontubercul… (NCT04677569) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
United States425 participantsStarted 2021-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female, ≥ 18 years of age (19 years or older in South Korea, 20 years or older in Japan).
* Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment.
* A chest computerized tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening.
* Willingness and ability to adhere to prescribed study treatment during the study.
* Women of childbearing potential (WOCBP) (ie, fertile following menarche and until becoming postmenopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice a highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are:
* true abstinence (refraining from heterosexual intercourse during the entire study),
* copper intrauterine device (IUD),
* hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \[combined with barrier method\]),
* exclusive homosexual relationship, or
* sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post pro…
What they're measuring
1
Change from Baseline in Respiratory Symptom Score at Month 13