drugset / Trial / NCT04677543
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2020-12-22
- Primary completion
- 2023-05-09
- Completion
- 2023-05-09
Publications
- Daley CL, van Ingen J, Chalmers JD, Flume PA, Griffith DE, Hasegawa N, Morimoto K, Winthrop KL, Sheu CC, Avsar K, Andrisani D, Codecasa LR, Terschlusen E, May D, Yuen DW, Wu P, Hassan M, Nevoret ML, Mange K. Amikacin liposome inhalation suspension in newly diagnosed Mycobacterium avium complex lung disease (ARISE): a 6-month double-blind, active comparator trial. Ann Am Thorac Soc. 2026 Apr 1;23(4):536-547. doi: 10.1093/annalsats/aaoaf064.
- Daley CL, Chalmers JD, Flume PA, Griffith DE, Hasegawa N, Morimoto K, Winthrop KL, Sheu CC, Avsar K, Andrisani D, Codecasa LR, Yuen DW, Hassan M, Nevoret ML, Mange K. Trial Conduct, Baseline Characteristics, and Symptom Burden of Patients in the ARISE Study. Pulm Ther. 2025 Jun;11(2):269-283. doi: 10.1007/s41030-025-00293-3. Epub 2025 Apr 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amikacin | Small molecule | 590 mg | Inhaled |
| Comparator | Azithromycin | Small molecule | 250 mg | Oral |
| Comparator | Ethambutol | Small molecule | 15 mg/kg | Oral |