A 24-week Prospective, Open-label, Multicenter, Single-arm Real-world Study for Atectura Inhalation Capsule (150/80, 150/160, and 150/320 µg) via Breezhaler

What this Trial Is About

Researchers are observing the safety and effectiveness of Atectura inhalation capsule in people aged 12 to 100 years with asthma over a 24-week period. This non-interventional, open-label study takes place across multiple centers and follows routine clinical practice without additional diagnostic or monitoring procedures beyond standard care. The study aims to gather real-world data on the use of Atectura as prescribed under approved labeling in Korea. Participants will use one of three doses of Atectura inhalation capsule delivered via Breezhaler: 150/80 µg, 150/160 µg, or 150/320 µg of indacaterol acetate/mometasone furoate. Treatments are prescribed by physicians according to routine care, and patients who have already started Atectura before joining the study will be included. No randomization or placebo control is involved since this is an observational study. During the study, researchers will track adverse events and serious adverse events over 24 weeks to evaluate safety. Lung function changes will be measured by trough FEV1 at baseline and week 12, along with asthma control using the ACT score. Effectiveness will also be assessed by investigators at week 12. Patient data on drug reactions and lung function changes will be collected to better understand treatment impact. The study runs until December 2026 and involves regular clinical assessments without extra tests beyond standard asthma care.

A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®