Status:
RECRUITING
A 24-week rPMS Study in Real-world Setting for Enerzair
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-100 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 Enerzair inhalation capsule fo...
Detailed Description
The two different doses of Enerzair inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or mo...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 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
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 :
March 11 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05274425
Start Date
May 9 2022
End Date
March 11 2027
Last Update
January 14 2025
Active Locations (16)
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1
Novartis Investigative Site
Daegu, Dalseo Gu, South Korea, 42602
2
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea, 26426
3
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, South Korea, 14584
4
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea, 13620