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RECRUITING
NCT05274425

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2022-05-09

Completion Date

2027-03-11

Last Updated

2026-04-02

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (20)

Novartis Investigative Site

Daegu, Dalseo gu, South Korea

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Goyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Novartis Investigative Site

Suncheon, Jeollanam-do, South Korea

Novartis Investigative Site

Cheongju-si, North Chungcheong, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Daegu, South Korea

Novartis Investigative Site

Gwangju, South Korea

Novartis Investigative Site

Gyeonggi-do, South Korea

Novartis Investigative Site

Gyeongsangnam Do, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea