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A 24-week rPMS Study in Real-world Setting for Enerzair
Sponsor: Novartis Pharmaceuticals
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
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.
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