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RECRUITING
NCT05217810

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

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 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

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.

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