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
Atectura inhalation capsule for up to 24 weeks under routine clinical practice. 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 monitoring will be not conducted for this study
Interventions
Atectura inhalation capsule (150/160ug)
Atectura inhalation capsule (150/320ug)
Atectura inhalation capsule (150/80ug)
Eligibility Criteria
Inclusion Criteria:
1. 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
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 (For patients under the age
of 18, consent and signature of a legal representative is required)
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
Worldwide Contacts
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