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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Enerzair 150/50/80 μg; Other: Enerzair 150/50/160 μg

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• South Korea
  • Busan, South Korea, 49201
    • Recruiting
    • Novartis Investigative Site
  • Daegu, South Korea, 705703
    • Recruiting
    • Novartis Investigative Site
  • Gwangju, South Korea, 501171
    • Recruiting
    • Novartis Investigative Site
  • Gyeonggi-do, South Korea, 14353
    • Active, not recruiting
    • Novartis Investigative Site
  • Gyeongsangnam Do, South Korea, 630-522
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 06273
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Active, not recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 04763
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 2447
    • Recruiting
    • Novartis Investigative Site
  • Dalseo gu
    • Daegu, Dalseo gu, South Korea, 42602
      • Recruiting
      • Novartis Investigative Site
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Recruiting
      • Novartis Investigative Site
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14584
      • Completed
      • Novartis Investigative Site
    • Bundang Gu, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Novartis Investigative Site
    • Goyang-si, Gyeonggi-do, South Korea, 10475
      • Completed
      • Novartis Investigative Site
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, South Korea, 561 712
      • Recruiting
      • Novartis Investigative Site
  • Jeollanam-do
    • Suncheon, Jeollanam-do, South Korea, 540-719
      • Completed
      • Novartis Investigative Site
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Active, not recruiting
      • Novartis Investigative Site
  • Seoul
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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,	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics of patients in relation to the investigator assessment	Logistic regression analysis will be performed to determine factors affecting the effectiveness (improved) in the investigator assessment, out of baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. above 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.	12 weeks
Change from baseline in trough FEV1	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.	Baseline, week 12
Change from baseline in ACT score	The Asthma Control Test (ACT) is a validated tool to assess overall asthma control. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.	Baseline, week 12
Effective rate and ineffective rate by investigator assessment	The investigator comprehensively and subjectively evaluates the therapeutic effect of a treatment. The investigators can select effective, if they think patient's symptom was improved or ineffective, if they think patient's symptom was unchanged/aggravated.	week 12
Baseline characteristics of patients showing adverse events	The incidence rates of AEs will be presented by factors, such as subject baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. above 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.	24 weeks
Baseline characteristics of patients showing adverse drug reactions	The incidence rates of ADRs will be presented by factors, such as subject baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. above 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.	24 weeks
Baseline characteristics of patients in relation to changes from baseline in trough FEV1	Regression analysis will be performed to determine factors affecting the change in trough FEV1, out of baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.	12 weeks
Baseline characteristics of patients in relation to changes from baseline in trough ACT score	Regression analysis will be performed to determine factors affecting the change in trough ACT score, out of baseline characteristics (age (<65 vs. ≥65 years), male vs. female, pregnancy (yes vs. no), family history (yes vs. no), exacerbation history (0 vs. 1), smoking history (yes vs. no), comorbidity (yes vs. no), concomitant medication/ therapy (yes vs. no)), study treatment information, and special populations.	12 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Korea; QVM149; Enerzair
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: CQVM149BKR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO