A Comparison of the Clinical Effectiveness of Inhaled Triple Therapy (Fluticasone Furoate / Umeclidinium Bromide / Vilanterol) in a Single Inhaler (TRELEGY™ ELLIPTA™) With Inhaled Non-ELLIPTA™ Multiple Inhaler Triple Therapies in COPD Patients in the US Within a Usual Care Setting in a Prospective Pre-Post Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Annualized rate of moderate, severe COPD exacerbations
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects who inhaled non-ELLIPTA MITT
Subjects with moderate or severe exacerbation in the past year and history of use of inhaled non-ELLIPTA MITT of ICS/LABA/LAMA within a routine clinical practice setting in the 52-week retrospective pre-switch period.
干预措施: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists (Drug)
Subjects receiving TRELEGY ELLIPTA SITT
Subjects will receive FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg), inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) in the 52-week prospective post-switch period.
干预措施: Fluticasone furoate/umeclidinium/vilanterol (Drug)
结局指标
主要结局
Annualized rate of moderate, severe COPD exacerbations
时间窗: 104 weeks
Moderate and severe COPD exacerbations will be defined using an algorithm agreed upon by GlaxoSmithKline and the health plans that identifies these events from health plan medical claims data. Moderate exacerbation is any physician office visit, urgent care visit or emergency room visit for COPD where any oral corticosteroids or antibiotics are prescribed during visit. Severe exacerbations are any COPD related inpatient visit. Exacerbations will be determined in the same fashion in the retrospective pre-switch period and the prospective post switch period.
次要结局
未报告次要终点
