NCT03964220已完成不适用
The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,857
- 试验地点
- 1
- 主要终点
- Time to First Exacerbation
研究概览
简要总结
To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
- •Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
- •Patients will be required to have available records 12 months prior to the index date.
排除标准
- •Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
- •Patients with a diagnosis of COPD at any time during the study period will be excluded.
- •Those who are on biologics at baseline will be removed.
- •After the PSM process, unmatched patients will be excluded.
研究组 & 干预措施
Patients with Asthma
干预措施: Tiotropium Respimat® (Drug)
Patients with Asthma
干预措施: Inhaled Corticosteroid/Long-acting beta-agonist (Drug)
结局指标
主要结局
Time to First Exacerbation
时间窗: From baseline until end of follow-up, up to 3 years
Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded.
次要结局
- Rate of Exacerbation at 6 Months and 1 Year of Follow-up(At 6 month and 1 year of follow-up)
- Health Care Resource Utilization (HCRU) During Follow-up(During follow-up period, From baseline until end of follow-up, up to 3 years)
- Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period(From baseline until end of follow-up, up to 3 years)
- Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period(From baseline until end of follow-up, up to 3 years)
研究者
研究点 (1)
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