Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02628600 ↗
Enrolled (actual)
163
Serious AEs
31.9%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 68; 90; 20; 32 participants
◆ Published Evidence
Established
73citations · ~15 / year
Amikacin Liposome Inhalation Suspension for <i>Mycobacterium avium</i> Complex Lung Disease: A 12-Month Open-Label Extension Clinical Trial.
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).
Linked Publications (2)
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Amikacin Liposome Inhalation Suspension for <i>Mycobacterium avium</i> Complex Lung Disease: A 12-Month Open-Label Extension Clinical Trial.
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Management and Resolution of Hypersensitivity Pneumonitis-Related Events in Japanese Patients Treated with Amikacin Liposome Inhalation Suspension in the CONVERT and INS-312 Clinical Trials.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.