A Study to Examine the Effects and Side Effects of Inhaled Amikacin in Patients with MAC Lung Disease

Efficacy and Safety of Amikacin Liposome Inhalation Suspension for Mycobacterium Avium Complex Pulmonary Disease: A Real-World, Prospective Registry Study - (AIR-MAC study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250244

Enrollment

Registered

2025-07-22

Start date

2025-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium avium Complex

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a patient who is planned to undergo inhaled amikacin treatment for pulmonary Mycobacterium avium complex infection

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
the culture conversion rate by month 6 of treatment and the change from baseline in the QOL-B score.	—

Secondary

Measure	Time frame
1. Change from baseline in the 6-minute walk test (6MWT) 2. Time to culture conversion 3. Change from baseline in health-related quality of life measures, including the St. George`s Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and the Patient Global Impression of Severity (PGI-S) and Change (PGI-C).	—

Contacts

Public ContactKei Nakashima

Kameda Medical Center

kei.7.nakashima@gmail.com+81-4-7092-2211

Outcome results