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

Официальное название

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)

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Incidence of adverse events and serious adverse events [Срок оценки: 24 weeks]
• Incidence of unexpected adverse events and unexpected serious adverse events [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 18 центров

• 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
• … и ещё 10 центров

Идентификаторы

NCT: NCT05217810 · CQMF149EKR01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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