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

NCT05217810 · tracked via the Priya Life Science South Korea tracker

Sponsor

Novartis Pharmaceuticals

Phase

Observational

Started

2022-05-09

Last updated

2026-09-24

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Atectura inhalation capsule (150/80ug)Atectura inhalation capsule (150/160ug)Atectura inhalation capsule (150/320ug)

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.

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

100 Years

Healthy volunteers

Inclusion Criteria: 1. Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 μg) via Breezhaler, as per the approved label information 2. Patients who participate in the study after signing the consent form for data collection and use (Data Privacy ICF) after receiving a clear explanation of the objectives and nature of the study from the investigator (For patients under the age of 18, consent and signature of a legal representative is required) Exclusion Criteria: 1. Patients who are contraindicated for this medicinal product as described in the Precautions for Use in the label information (package insert) A. Patients with hypersensitivity reaction to this medicinal product or any of its constituents B. Because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc. 2. Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required 3. Patients participating in other interventional clinical trials

Primary outcome measure(s)

Incidence of adverse events and serious adverse events — 24 weeks
Incidence of AE and SAE will be collected
Incidence of unexpected adverse events and unexpected serious adverse events — 24 weeks
Incidence of unexpected AE and SAE will be collected. The term "unexpected" means not listed in local label

Trial sites (18)

Facility	City	Region
Novartis Investigative Site	Daegu	Dalseo gu
Novartis Investigative Site	Kangwon Do	Gangneung si
Novartis Investigative Site	Wŏnju	Gangwon-do
Novartis Investigative Site	Goyang-si	Gyeonggi-do
Novartis Investigative Site	Guri-si	Gyeonggi-do
Novartis Investigative Site	Jinju	Gyeongsangnam-do
Novartis Investigative Site	Jeonju	Jeollabuk-do
Novartis Investigative Site	Iksan Si	Jeonlabuk Do
Novartis Investigative Site	Daejeon	Korea
Novartis Investigative Site	Busan	South Korea
Novartis Investigative Site	Gyeongsangnam Do	South Korea
Novartis Investigative Site	Jeju City	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05217810 on ClinicalTrials.gov ↗ ← All trials in South Korea