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

NCT ID: NCT05274425

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2027-03-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enerzair 150/50/80 μg

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

Enerzair 150/50/80 μg

Intervention Type OTHER

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

Enerzair 150/50/160 μg

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

Enerzair 150/50/160 μg

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Daegu, Dalseo Gu, South Korea

Site Status RECRUITING

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, South Korea

Site Status WITHDRAWN

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Deogyang Gu Goyang Si, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Suncheon, Jeollanam-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Cheongju-si, North Chungcheong, South Korea

Site Status RECRUITING

Novartis Investigative Site

Busan, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Daegu, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Gwangju, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Gyeongsangnam Do, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CQVM149BKR01

Identifier Type: -

Identifier Source: org_study_id

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