Study Description
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. 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 monitoring will be not conducted for this study.
Interventions
Enerzair 150/50/160 μg
Enerzair 150/50/80 μg
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
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