A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
1 other identifier
observational
600
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 23, 2026
August 11, 2025
August 1, 2025
4.6 years
November 30, 2021
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events and serious adverse events
Incidence of AE and SAE will be collected
24 weeks
Incidence of unexpected adverse events and unexpected serious adverse events
Incidence of unexpected AE and SAE will be collected. The term "unexpected" means not listed in local label
24 weeks
Secondary Outcomes (6)
change from baseline in trough FEV1
Baseline, week 12
change from baseline in ACT score
Baseline, week 12
Effective rate and ineffective rate by investigator assessment
week 12
Baseline characteristics of patients showing adverse events/adverse drug reactions
24 weeks
Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score
12 weeks
- +1 more secondary outcomes
Study Arms (3)
Atectura inhalation capsule (150/80ug)
Indacaterol acetate/Mometasone furoate; 150/80ug
Atectura inhalation capsule (150/160ug)
Indacaterol acetate/Mometasone furoate; 150/160ug
Atectura inhalation capsule (150/320ug)
Indacaterol acetate/Mometasone furoate; 150/320ug
Interventions
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
Eligibility Criteria
subjects who received at least one dose of Atectura inhalation capsule via Breezhaler and that have provided consent for their data collection.
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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.
- Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
- Patients participating in other interventional clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Novartis Investigative Site
Daegu, Dalseo gu, 42602, South Korea
Novartis Investigative Site
Kangwon Do, Gangneung si, 210 711, South Korea
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426, South Korea
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 10380, South Korea
Novartis Investigative Site
Guri-si, Gyeonggi-do, 471-701, South Korea
Novartis Investigative Site
Jeonju, Jeollabuk-do, 561 712, South Korea
Novartis Investigative Site
Iksan Si, Jeonlabuk Do, 570-711, South Korea
Novartis Investigative Site
Daejeon, Korea, 35015, South Korea
Novartis Investigative Site
Busan, 48108, South Korea
Novartis Investigative Site
Gyeongsangnam Do, 630-522, South Korea
Novartis Investigative Site
Jeju City, 63241, South Korea
Novartis Investigative Site
Jinju, 660-702, South Korea
Novartis Investigative Site
Seoul, 04763, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Seoul, 06273, South Korea
Novartis Investigative Site
Seoul, 137 707, South Korea
Novartis Investigative Site
Taegu, 41944, South Korea
Novartis Investigative Site
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
February 1, 2022
Study Start
May 9, 2022
Primary Completion (Estimated)
December 23, 2026
Study Completion (Estimated)
December 23, 2026
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share