An Open Label, Multi-centre, Post Marketing Surveillance to Observe the Safety and Effectiveness of ARNUITY Administered in Patients With Asthma in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 1
- 主要终点
- Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)
研究概览
简要总结
This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects older than 12 years of age and adult subjects with asthma
- •Subjects who will administer ARNUITY in accordance with the product information approved in Korea
- •Subjects who have signed the informed consent form for the PMS
排除标准
- •Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment
- •Subjects who have any known hyper-sensitivity to the drug or its ingredients
- •Subjects who have severe hypersensitive reactions to milk proteins
- •Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
Subjects who received ARNUITY
This PMS will be conducted with subjects who were administered ARNUITY in accordance with the approved label.
干预措施: Arnuity (Drug)
结局指标
主要结局
Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs)
时间窗: Up to 22 months
A SAE refers to any one of the following adverse events, which: results in death or is life-threatening; results in or prolongs hospitalization; results in persistent or serious disability or incapacity; results in a birth defect or anomaly; or is an important medical event. SADR is defined a SAE whose causal relationship with the product cannot be ruled out.
Change in Forced Vital Capacity (FVC) before and after ARNUITY administration
时间窗: Week 0, Week 24
The physicians shall collect FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FVC results before and after administration of the product shall be analyzed using a paired t-test.
Change in FEV1/FVC ratio before and after ARNUITY administration
时间窗: Week 0, Week 24
The physicians shall collect FEV1/FVC data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1/ FVC ratio before and after administration of the product shall be analyzed using a paired t-test
Incidence rates of unexpected AEs and adverse drug reactions (ADRs)
时间窗: Up to 22 months
An ADR is defined as an adverse event whose causal relationship with the product cannot be ruled out.
Incidence rate of adverse events (AEs) after ARNUITY administration
时间窗: Up to 22months
An AE is defined as any undesirable, unintended signs (e.g., abnormal laboratory findings), symptoms, or disease that may occur after administration or during use of the product, and does not necessarily have to have a causal relationship with the product.
Change in Forced Expiratory Volume in 1 Second (FEV1) before and after ARNUITY administration
时间窗: Week 0, Week 24
The physicians shall collect FEV1 data at Week 0 and Week 24 after Arnuity administration. The change in the FEV1 results before and after administration of the product shall be analyzed using a paired t-test.
Changes in the asthma symptom control results before and after ARNUITY administration
时间窗: Week 0, Week 24
The physician shall collect the asthma symptom control results at Week 0 and Week 24 after Arnuity administration, based on the symptoms the subjects experienced for the past 4 weeks. The results of the asthma symptom control shall be categorized into 'Controlled', 'Partly Controlled', and 'Uncontrolled'.
Number of subjects with abnormal findings as assessed by physician's effectiveness assessment
时间窗: Week 24
For the subjective assessment of effectiveness, the physicians shall assess physician's effectiveness assessment at Week 24 after administration of Arnuity, based on the pulmonary function test and/or asthma symptom control.
次要结局
未报告次要终点