NCT05274425

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

A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 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 Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

Detailed description

The two different doses of Enerzair 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	Enerzair 150/50/80 μg	There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.
OTHER	Enerzair 150/50/160 μg	There is no treatment allocation. Patients administered Enerzair by prescription that have started before inclusion of the patient into the study will be enrolled.

Timeline

• Start date: 2022-05-09
• Primary completion: 2027-03-11
• Completion: 2027-03-11
• First posted: 2022-03-10
• Last updated: 2026-04-02

Locations

20 sites across 1 country: South Korea