Status:
RECRUITING
A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
12-100 years
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 fo...
Detailed Description
The three different doses of Atectura inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 23 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05217810
Start Date
May 9 2022
End Date
December 23 2026
Last Update
August 11 2025
Active Locations (18)
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1
Novartis Investigative Site
Daegu, Dalseo gu, South Korea, 42602
2
Novartis Investigative Site
Kangwon Do, Gangneung si, South Korea, 210 711
3
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea, 26426
4
Novartis Investigative Site
Goyang-si, Gyeonggi-do, South Korea, 10380