At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 99 enrolled
Drug / intervention
ALIS +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
In Brief
A Phase 3 clinical trial evaluating ALIS, Azithromycin, and 2 other interventions for Mycobacterium Infections, Nontuberculous. Completed, enrolled 99 participants across 62 sites in 12 countries.
Detailed Summary
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycobacterium Infections, Nontuberculous
CountriesArgentina, Australia, Austria, Denmark, Germany, Israel, Italy, New Zealand, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartDec 2020
Primary CompletionMay 2023
TodayJul 2026
First PostedDec 21, 2020
Enrollment StartDec 22, 2020
Primary CompletionMay 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.5 years ago
Interventions
ALISdrug
Inhalation via nebulization over approximately 6 to 15 minutes.
Azithromycindrug
Oral tablet
Ethambutoldrug
Oral tablet
ELCdrug
Inhalation via nebulization over approximately 6 to 15 minutes.