Evaluating the safety and effectiveness of Atectura for asthma management

A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura® (QMF149 150/80 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d. Via Breezhaler)

This study is testing how safe and effective the Atectura inhaler is for people with asthma over six months in everyday use.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 12 Years to 100 Years
• Sex: All
• Sponsor: Novartis (industry)
• Locations: 18 sites (Daegu, Dalseo gu and 17 other locations)
• Trial ID: NCT05217810 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and effectiveness of the Atectura inhalation capsule in patients with asthma over a 24-week period in a real-world clinical setting. Participants will receive one of three prescribed doses of Atectura via Breezhaler, following the approved label information in Korea. The study will not involve any additional diagnostic or monitoring interventions beyond routine clinical practice. Data will be collected from patients who consent to participate after being informed about the study's objectives.

Who should consider this trial

Good fit: Ideal candidates include adolescents and adults aged 12 and older with a physician's diagnosis of asthma who are prescribed Atectura.

Not a fit: Patients who are contraindicated for Atectura due to hypersensitivity or lactose intolerance will 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 Atectura for asthma patients.

How similar studies have performed: Other studies evaluating similar ICS/LABA combinations have shown promising results, indicating that this approach is supported by prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 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 (For patients under the age of 18, consent and signature of a legal representative is required)

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 17 other locations

• Novartis Investigative Site — Daegu, Dalseo gu, South Korea (RECRUITING)
• Novartis Investigative Site — Kangwon Do, Gangneung si, South Korea (COMPLETED)
• Novartis Investigative Site — Wŏnju, Gangwon-do, South Korea (ACTIVE_NOT_RECRUITING)
• Novartis Investigative Site — Goyang-si, Gyeonggi-do, South Korea (RECRUITING)
• Novartis Investigative Site — Guri-si, Gyeonggi-do, South Korea (COMPLETED)
• Novartis Investigative Site — Jeonju, Jeollabuk-do, South Korea (RECRUITING)
• Novartis Investigative Site — Iksan Si, Jeonlabuk Do, South Korea (RECRUITING)
• Novartis Investigative Site — Daejeon, Korea, South Korea (COMPLETED)
• Novartis Investigative Site — Busan, South Korea (RECRUITING)
• Novartis Investigative Site — Gyeongsangnam Do, South Korea (COMPLETED)
• Novartis Investigative Site — Jeju City, South Korea (RECRUITING)
• Novartis Investigative Site — Jinju, South Korea (RECRUITING)
• Novartis Investigative Site — Seoul, South Korea (RECRUITING)
• Novartis Investigative Site — Seoul, South Korea (RECRUITING)
• Novartis Investigative Site — Seoul, South Korea (RECRUITING)
• Novartis Investigative Site — Seoul, South Korea (RECRUITING)
• Novartis Investigative Site — Taegu, South Korea (RECRUITING)
• Novartis Investigative Site — Ulsan, South Korea (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Asthma, Korea, ICS/LABA combination