Last Update: Feb 08, 2024
A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura® (QMF149 150/80 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d. Via Breezhaler)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CQMF149EKR01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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

Asthma
Recruiting
600
May 09, 2022
Dec 23, 2026
All
12 Years - (Child, Adult, Older Adult)

Interventions

Other

Atectura inhalation capsule (150/160ug)

There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
Other

Atectura inhalation capsule (150/320ug)

There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
Other

Atectura inhalation capsule (150/80ug)

There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.

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

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