2023-509026-21-00进行中（未招募）4 期
A prospective, real-world, interventional study to evaluate the effect of mepolizumab on achieving clinical remission in participants with severe asthma.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- 1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months
研究概览
简要总结
- Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Assessment Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or over
- •Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA
- •Participants with ≥60% predicted FEV1 and ≤4 exacerbations per year, as confirmed by the physician.
- •Written informed consent.
排除标准
- •Investigator concerns about participant’s willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
- •Any NUCALA use in the 6 months prior to enrollment.
- •Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids.
- •Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.
- •Participating in an interventional study with a treatment intervention.
- •Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis).
- •Current smokers.
结局指标
主要结局
1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months
1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months
次要结局
- 1. • Clinically Significant Asthma Exacerbations (CSE) • CSE leading to hospitalization/Emergency room (ER) visits 2. • Achieving oral corticosteroids (OCS) sparing remission • Achieving 3-component clinical remission 3. Change in the 15-item mini-AQLQ overall score from baseline to 12 months
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (1)
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