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

NCT05274425 | Recruiting

• 1 other identifier: CQVM149BKR01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Asthma

Keywords

Enerzair; QVM149; Korea

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events and serious adverse events

  Incidence of AE and SAE to be collected

  24 weeks

• Incidence of unexpected adverse events and unexpected serious adverse events

  Incidence of unexpected AE and SAE. The term "unexpected" means not listed in local label.

  24 weeks

Secondary Outcomes (8)

• Change from baseline in trough FEV1

  Baseline, week 12

• Change from baseline in ACT score

  Baseline, week 12

• Effective rate and ineffective rate by investigator assessment

  week 12

• Baseline characteristics of patients showing adverse events

  24 weeks

• Baseline characteristics of patients showing adverse drug reactions

  24 weeks

Study Arms (2)

Enerzair 150/50/80 μg

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

Other: Enerzair 150/50/80 μg

Enerzair 150/50/160 μg

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

Other: Enerzair 150/50/160 μg

Interventions

Enerzair 150/50/80 μg 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 150/50/80 μg

Enerzair 150/50/160 μg 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who received at least one dose of Enerzair inhalation capsule via Breezhaler and that have provided consent for their data collection.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
• Patients participating in other interventional clinical trials

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Daegu, Dalseo gu, 42602, South Korea

RECRUITING

Novartis Investigative Site

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Novartis Investigative Site

Bucheon-si, Gyeonggi-do, 14584, South Korea

COMPLETED

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, 13620, South Korea

RECRUITING

Novartis Investigative Site

Goyang-si, Gyeonggi-do, 10475, South Korea

COMPLETED

Novartis Investigative Site

Jeonju, Jeollabuk-do, 561 712, South Korea

RECRUITING

Novartis Investigative Site

Suncheon, Jeollanam-do, 540-719, South Korea

COMPLETED

Novartis Investigative Site

Cheongju-si, North Chungcheong, 28644, South Korea

ACTIVE NOT RECRUITING

Novartis Investigative Site

Seoul, Seoul, 06351, South Korea

RECRUITING

Novartis Investigative Site

Busan, 49201, South Korea

RECRUITING

Novartis Investigative Site

Daegu, 705703, South Korea

RECRUITING

Novartis Investigative Site

Gwangju, 501171, South Korea

RECRUITING

Novartis Investigative Site

Gyeonggi-do, 14353, South Korea

ACTIVE NOT RECRUITING

Novartis Investigative Site

Gyeongsangnam Do, 630-522, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

ACTIVE NOT RECRUITING

Novartis Investigative Site

Seoul, 04763, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 05505, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06273, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 2447, South Korea

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: March 10, 2022
• Study Start: May 9, 2022
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (20)