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)

ClinicalTrials.gov Identifier: NCT05274425

Novartis Reference Number: CQVM149BKR01

Last Update: Jun 14, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Asthma
Phase 
Not Given
Overall status 
Recruiting
Start date 
May 19, 2022
Completion date 
Dec 23, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

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.
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.

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Suncheon, 540-719
Jeollanam-do
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]