A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®

Official title

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)

Overview

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice.

Detailed description

The three different doses of Atectura 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

Interventions

• Other Atectura inhalation capsule (150/80ug)
  There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
• Other Atectura inhalation capsule (150/160ug)
  There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.
• Other Atectura inhalation capsule (150/320ug)
  There is no treatment allocation. Patients administered Atectura by prescription that have started before inclusion of the patient into the study will be enrolled.

Primary outcome measures

• Incidence of adverse events and serious adverse events [Time frame: 24 weeks]
• Incidence of unexpected adverse events and unexpected serious adverse events [Time frame: 24 weeks]

Secondary outcome measures (6)

• change from baseline in trough FEV1 [Time frame: Baseline, week 12]
• change from baseline in ACT score [Time frame: Baseline, week 12]
• Effective rate and ineffective rate by investigator assessment [Time frame: week 12]
• Baseline characteristics of patients showing adverse events/adverse drug reactions [Time frame: 24 weeks]
• Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score [Time frame: 12 weeks]
• Baseline characteristics of patients in relation to the investigator assessment [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• 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
• 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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

South Korea · 18 centers

• Novartis Investigative Site — Daegu
• Novartis Investigative Site — Kangwon Do
• Novartis Investigative Site — Wŏnju
• Novartis Investigative Site — Goyang-si
• Novartis Investigative Site — Guri-si
• Novartis Investigative Site — Jeonju
• Novartis Investigative Site — Iksan Si
• Novartis Investigative Site — Daejeon
• … and 10 more centers

Identifiers

NCT: NCT05217810 · CQMF149EKR01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗