Exacerbation Risk in Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,899
- 试验地点
- 1
- 主要终点
- Time to First Severe Exacerbation
研究概览
简要总结
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
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 two asthma diagnosis
- •Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
- •Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use
排除标准
- •Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
- •Patients less than 12 years of age
- •Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
- •Patients with prior Tio or ICS/LABA use during the 6-month baseline period
- •Patients with urinary bladder obstruction, urinary retention, and glaucoma
- •After the propensity score matching (PSM) process, unmatched patients
研究组 & 干预措施
tiotropium + inhaled corticosteroids (ICS) group
干预措施: tiotropium (Drug)
tiotropium + inhaled corticosteroids (ICS) group
干预措施: inhaled corticosteroids (ICS) (Drug)
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group
干预措施: long-acting β2-agonists (LABA) (Drug)
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group
干预措施: inhaled corticosteroids (ICS) (Drug)
结局指标
主要结局
Time to First Severe Exacerbation
时间窗: From index date to first severe exacerbation, up to 1 year.
Severe exacerbation defined as: * Hospitalization with primary diagnosis of asthma or * Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations). Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
次要结局
- Rate of Exacerbation at 6 Months and One Year(at 6 months and one year)
- Health Care Resource Utilization (HCRU)(From index date to end of follow-up, up to 1 year.)
- Percentage of Patients With Exacerbation(From index date through first report of exacerbation, up to 1 year.)
- Time to First Moderate-or-severe Exacerbation(From index date to first moderate-or-severe exacerbation, up to 1 year.)
- Percentage of Patients With Health Care Resource Utilization (HCRU)(From index date to end of follow-up, up to 1 year.)
- Percentage of Patients With Use of Rescue Medications(From index date to end of follow-up, up to 1 year.)