NCT05217810

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

A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura® (QMF149 150/80 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d. Via Breezhaler)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice.

Detailed description

The three different doses of Atectura inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Atectura inhalation capsule (150/80ug)	There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
OTHER	Atectura inhalation capsule (150/160ug)	There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
OTHER	Atectura inhalation capsule (150/320ug)	There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.

Timeline

• Start date: 2022-05-09
• Primary completion: 2026-12-23
• Completion: 2026-12-23
• First posted: 2022-02-01
• Last updated: 2025-08-11

Locations

18 sites across 1 country: South Korea