Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone

• Status: Completed
• Trial end date: 2019-04-03
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC) that were refractory to treatment.

Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Amikacin

Criteria

Inclusion Criteria:

1. Be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was completed no more than 12 months before screening

2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT

3. Be willing to adhere to multi-drug treatment regimen during the course of the study

Exclusion Criteria:

1. Patients with cystic fibrosis

2. Positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.

3. Active pulmonary tuberculosis requiring treatment at screening

4. History of lung transplantation

5. Prior exposure to LAI (including clinical study).