An Observational, Non-Interventional Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Commercially Insured Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22,369
- 试验地点
- 1
- 主要终点
- Time to and rate of all-cause mortality
研究概览
简要总结
Patients with chronic obstructive pulmonary disease (COPD) have elevated risk of mortality and cardiopulmonary events, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce mortality and cardiopulmonary event risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes associated with SITTs versus multiple inhaler triple therapies (MITTs). SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum's de-identified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality (ACM) and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020-June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •1 initial prescription for BGF or MITT starting October 1, 2020 through to the latest available data update, AND
- •Age ≥40 years on date of first prescription for BGF or MITT episode, AND
- •Continuous medical and pharmacy health plan eligibility for ≥12-months (365 days) prior to first prescription for BGF or MITT AND
- •2 medical claims with diagnoses for COPD at least 30 days apart occurring on or anytime in the patient's available 24-month history before the first BGF prescription or MITT episode, with one diagnosis occurring in the immediate 12-month period prior to or on initiation of BGF or MITT
排除标准
- •Age <40 at time of treatment initiation
- •Invalid or unknown gender
- •If death date occurs prior to or on study index date
- •<12 months (365 days) of medical and pharmacy health plan eligibility/coverage prior treatment initiation
- •Presence of ≥1 prescription claim for any triple therapy during the patient's entire available baseline history (BGF, FF/UMEC/VI or MITT)
- •"potential MITT use" in baseline, MITT for baseline purposes will be defined as ≥1 days continuous days where all three MITT components (ICS, LABA, LAMA) are observed in combination (dual + monotherapy) or as three separate monotherapy components
- •History of any of the following conditions, procedures or events during the immediate baseline 12-month period: (a) ≥1 medical claim (i.e., office, ED or hospital) in any position with a diagnosis for alpha-1-antitrypsin deficiency, interstitial fibrosis, lung cancer, pulmonary embolism, sarcoidosis; (b) ≥1 medical claim for hospice services; (c) Any medical Bill Type Code (BILL_TYPE_CODE ) starting with 81 or 82; or Revenue codes (RVNU_CD): 0651-0659; (d) ≥1 medical claim with a diagnosis code of encounter related to clinical trial participation (Z00.6) at any point during the study period (including both baseline and follow-up periods)
研究组 & 干预措施
COPD Patients
COPD patients initiating BGF or MITT
干预措施: BGF (Drug)
COPD Patients
COPD patients initiating BGF or MITT
干预措施: MITT (Drug)
结局指标
主要结局
Time to and rate of all-cause mortality
时间窗: During available follow-up; median 313 days
Time to and rate of all-cause mortality observed after initiation of BGF or MITT; all-cause mortality as defined by the available death information contained in the database.
次要结局
- Time to and rate of cardiopulmonary events(During available follow-up; median 313 days)