Phase 3
N=163
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
NTM Lung Infection Due to MAC
Bottom Line
View on ClinicalTrials.gov: NCT02628600 ↗Enrolled (actual)
163
Serious AEs
31.9%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 68; 90; 20; 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LAI 590 mg (Drug); Multi-drug regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Insmed Incorporated
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
68; 90; 20; 32; 8; 24 | — |
| SECONDARY Number of Participants Achieving Culture Conversion by Month 6 and Month 12 |
7; 24; 10; 30 | — |
| SECONDARY Time to Culture Conversion |
NA; NA | — |
| SECONDARY Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance |
435.9; 449.0; -10.4; -20.8; -10.1; -42.2 | — |
Summary
This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004).
Eligibility Criteria
Key Inclusion Criteria
- had successfully completed the Month 6 and End of Treatment visits in Study INS-212
- had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.
Key Exclusion Criteria
- achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6
Data sourced from ClinicalTrials.gov (NCT02628600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.