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A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
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 Atectura inhalation capsule for up to 24 weeks under routine clinical practice.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2022-05-09
Completion Date
2026-12-23
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (18)
Novartis Investigative Site
Daegu, Dalseo gu, South Korea
Novartis Investigative Site
Kangwon Do, Gangneung si, South Korea
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
Novartis Investigative Site
Goyang-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Guri-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Jeonju, Jeollabuk-do, South Korea
Novartis Investigative Site
Iksan Si, Jeonlabuk Do, South Korea
Novartis Investigative Site
Daejeon, Korea, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Gyeongsangnam Do, South Korea
Novartis Investigative Site
Jeju City, South Korea
Novartis Investigative Site
Jinju, 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
Taegu, South Korea
Novartis Investigative Site
Ulsan, South Korea