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

Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274425
• Other study ID #: CQVM149BKR01
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: December 23, 2026

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 23, 2026
• Est. primary completion date: December 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Cheongju si	Chungcheongbuk Do
Korea, Republic of	Novartis Investigative Site	Daegu	Dalseo Gu
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Deogyang Gu Goyang Si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Gyeongsangnam Do
Korea, Republic of	Novartis Investigative Site	Jeonju Si	Jeollabuk Do
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Suncheon	Jeollanam Do
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-Do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and serious adverse events	Incidence of AE and SAE to be collected	24 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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