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

Novartis

Status: Enrolling

Conditions: Asthma

Treatments: Other: Enerzair 150/50/160 μg; Other: Enerzair 150/50/80 μg

Study type: Observational

Funder types: Industry

Identifiers

NCT05274425

CQVM149BKR01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Enerzair 150/50/80 μg

Description:

Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/80 μg) via Breezhaler

Treatment:

Other: Enerzair 150/50/80 μg

Enerzair 150/50/160 μg

Description:

Enerzair inhalation capsule (indacaterol acetate/glycopyrronium bromide/mometasone furoate; 150/50/160 μg) via Breezhaler,

Treatment:

Other: Enerzair 150/50/160 μg