Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 86
- 主要终点
- Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
研究概览
简要总结
The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment
The secondary objectives of this study include:
- To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy.
- To compare the time to first severe COPD exacerbation in both treatment arms.
- To compare the annual rate of severe COPD exacerbations in both treatment arms.
- To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis as defined by the study physician
- •Currently on one of the following maintenance therapies:
- •LAMA monotherapy
- •LABA monotherapy
- •ICS/LABA (FDC)
- •Physician determination that patient is not controlled on current pharmacotherapy
- •Adult patient 40 years of age or older at time of study enrollment
- •Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.
排除标准
- •Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)
- •Contraindication to any study medications (LAMA, LABA or ICS)
- •Documented diagnosis of current asthma
- •Pregnant or nursing women
- •Women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
研究组 & 干预措施
Stiolto Respimat
干预措施: Stiolto Respimat (Drug)
ICS plus LABA plus LAMA (triple therapy)
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
干预措施: ICS (Inhaled Corticosteroid) (Triple therapy) (Drug)
ICS plus LABA plus LAMA (triple therapy)
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
干预措施: LABA (Long-Acting Beta Agonist) (Triple therapy) (Drug)
ICS plus LABA plus LAMA (triple therapy)
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
干预措施: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) (Drug)
结局指标
主要结局
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period
时间窗: Baseline till end of study, up to 12 months.
Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves.
次要结局
- Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease(Baseline till end of study, up to 12 months.)
- Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(Baseline till end of study, up to 12 months.)
- Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(Baseline till end of study, up to 12 months.)
- Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period(12 months after baseline.)