A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Post-Marketing Study for Enerzair Inhalation Capsule (150/50/80 bcg and 150/50/160 bcg) via Breezhaler in Asthma

What this Trial Is About

Researchers are observing adult patients with asthma who have been prescribed Enerzair inhalation capsules to evaluate the safety and effectiveness of this treatment over a 24-week period in real-world clinical settings. This study is open-label, prospective, multicenter, and single-arm, designed to monitor outcomes without additional interventions beyond routine care. Participants will receive one of two doses of Enerzair via Breezhaler, either 150/50/80 micrograms or 150/50/160 micrograms, as prescribed according to approved labeling in Korea. No extra diagnostic or monitoring procedures beyond standard clinical practice will be conducted during the study. Throughout the study, participants will be monitored for adverse events and serious adverse events for up to 24 weeks. Researchers will also assess lung function using trough FEV1 measurements and asthma control using the ACT score at baseline and week 12. Effectiveness will be evaluated by investigator assessment, and patient characteristics related to safety and efficacy outcomes will be recorded. The study involves collection of data without altering prescribed treatment and ensures ongoing observation in a routine care environment.

A 24-week rPMS Study in Real-world Setting for Enerzair