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A 24-week rPMS Study in Real-world Setting for Enerzair

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Asthma

Interventions: Enerzair 150/50/80 μg, Enerzair 150/50/160 μg

Countries: South Korea

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 for up to 24 weeks under routine clinical practice.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. 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
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

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

Locations (21)

Daegu, Dalseo gu, South Korea
Wŏnju, Gangwon-do, South Korea
Bucheon-si, Gyeonggi-do, South Korea
Bundang Gu, Gyeonggi-do, South Korea
Goyang-si, Gyeonggi-do, South Korea
Yangsan, Gyeongsangnam-do, South Korea
Jeonju, Jeollabuk-do, South Korea
Suncheon, Jeollanam-do, South Korea
Cheongju-si, North Chungcheong, South Korea
Seoul, Seoul, South Korea
Busan, South Korea
Daegu, South Korea
Gwangju, South Korea
Gyeonggi-do, South Korea
Gyeongsangnam Do, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea