JPRN-jRCT1030210229招募中未知
Characteristics of patients with COPD newly treated with fluticasone/umeclidinium/vilanterol, budesonide/glycopyrronium/formoterol, or multiple inhaler triple therapy in the Medical Data Vision, Inc. clinical database
Akiyama Shoko0 个研究点目标入组 3,500 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 3,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. At least one pharmacy prescription claim(s) for Trelegy, Breztri Aerosphere, or a MITT between 1 September 2019 and most recent data available at the time of the study. The index date will be earliest initiation of treatment. Specifically:
- •a. Date of first prescription for Trelegy
- •b. Date of first prescription for Breztri Aerosphere
- •c. Any of the following scenarios for MITT, occurring no earlier than the start of the study period:
- •i. Prescription date of the last monotherapy component (ICS, LAMA, or LABA) overlapping with both of two preceding monotherapies (ICS, LAMA, or LABA)
- •ii. Prescription date of last monotherapy component (LAMA or ICS) overlapping with preceding dual therapy (ICS/LABA or LAMA/LABA, respectively)
- •iii. Prescription date of the last dual therapy component (ICS/LABA or LAMA/LABA) added to preceding monotherapy (LAMA or ICS, respectively)
- •2. Age >=40 at index date
- •3. >=2 outpatient or >=1 hospitalization record with an International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for COPD (J42, J43 or J44) in the 12 calendar months prior and including the index calendar month.
- •4. >=1 outpatient or hospitalization record with any ICD-10 diagnosis code in the 6-month period prior to the 12-month lookback period.
- •5. New users as of the index date. Defined as follows (not mutually exclusive):
- •a) No record of Trelegy in the 12-month lookback period (Objective 1a)
- •b) No record of triple therapy (Trelegy, Breztri Aerosphere, or MITT) in the 12-month lookback period (Objective 1b).
- •c) No record of any maintenance therapy (ICS, LABA, or LAMA-containing therapies) in the 12-month lookback period (Objective 2)
- •For Objectives 1b and 2, patients will be assigned to their respective study cohorts based on whether the index prescription record was for Trelegy, Breztri Aerosphere, or MITT.
排除标准
- •1.For the analysis under primary objective b, patients will be excluded if they used inhaled triple therapy (Trelegy, Breztri Aerosphere, or open inhaled triple treatment) in the 12-month lookback period
- •2.For the analysis under secondary objective, patients will be excluded if they used any maintenance therapy (ICS, LABA, or LAMA containing medications) in the 12-month lookback period
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