CompletedPhase 3

Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212

163 participantsStarted 2016-02-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From baseline to 28 days after end of treatment, up to 13 months

Trial details

NCT IDNCT02628600

SponsorInsmed Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-17

Results submitted2019-10-15

View on ClinicalTrials.gov More NTM Lung Infection Due to MAC trials