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Evaluating the safety and effectiveness of Enerzair for asthma management

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)

Observational Novartis · NCT05274425

This study is testing how safe and effective the Enerzair inhaler is for adults with asthma over six months in everyday settings.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations20 sites (Daegu, Dalseo gu and 19 other locations)
Trial IDNCT05274425 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of the Enerzair inhalation capsule in adult asthma patients over a 24-week period in a real-world clinical setting. Participants will receive either of the two prescribed doses of Enerzair via Breezhaler, following the approved label information in Korea. The study will not involve any additional diagnostic or monitoring interventions beyond routine clinical practice.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a physician's diagnosis of asthma who are prescribed Enerzair inhalation capsules.

Not a fit: Patients with contraindications to Enerzair or those experiencing acute asthma symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Enerzair for asthma patients.

How similar studies have performed: Other studies evaluating similar inhalation therapies have shown promising results, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Daegu, Dalseo gu and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaEnerzairQVM149Korea
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.