Last Update: Jun 20, 2024
A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CQVM149BKR01
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
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.

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

Interventions

Other

Enerzair 150/50/160 μg

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

Enerzair 150/50/80 μg

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

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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