A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®

Novartis

Status: Enrolling

Conditions: Asthma

Treatments: Other: Atectura inhalation capsule (150/160ug); Other: Atectura inhalation capsule (150/80ug); Other: Atectura inhalation capsule (150/320ug)

Study type: Observational

Funder types: Industry

Identifiers

NCT05217810

CQMF149EKR01

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 Atectura inhalation capsule for up to 24 weeks under routine clinical practice.

Full description

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

Enrollment: 600 estimated patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 3 patient groups

Atectura inhalation capsule (150/80ug)

Description:

Indacaterol acetate/Mometasone furoate; 150/80ug

Treatment:

Other: Atectura inhalation capsule (150/80ug)

Atectura inhalation capsule (150/160ug)

Description:

Indacaterol acetate/Mometasone furoate; 150/160ug

Treatment:

Other: Atectura inhalation capsule (150/160ug)

Atectura inhalation capsule (150/320ug)

Description:

Indacaterol acetate/Mometasone furoate; 150/320ug

Treatment:

Other: Atectura inhalation capsule (150/320ug)