Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3) (ENHANCE-3)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine (MK-5884) Versus Placebo for the Prevention of COPD Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (ENHANCE-3)
The purpose of this study is to evaluate the efficacy and safety of ensifentrine (MK-5884) compared with placebo for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also evaluate the efficacy of ensifentrine compared with placebo in improving lung function, improving health related quality of life, and preventing severe exacerbations.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Toll Free Number
- 电话号码：1-888-577-8839
- 邮箱：Trialsites@msd.com
学习地点
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Florida
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Hialeah Gardens、Florida、美国、33016
- 招聘中
- Family First Medical Research Center ( Site 4458)
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接触：
- Study Coordinator
- 电话号码：786-665-9374
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Loxahatchee Groves、Florida、美国、33470
- 招聘中
- Advanced Pulmonary Research Institute ( Site 4427)
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接触：
- Study Coordinator
- 电话号码：561-603-6688
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Indiana
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Valparaiso、Indiana、美国、46383
- 招聘中
- Velocity Clinical Research ( Site 4464)
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接触：
- Study Coordinator
- 电话号码：219-464-8302
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New York
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The Bronx、New York、美国、10455
- 招聘中
- CHEAR Center LLC ( Site 4407)
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接触：
- Study Coordinator
- 电话号码：347-270-1111
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South Carolina
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Charleston、South Carolina、美国、29406
- 招聘中
- Lowcountry Lung & Critical Care, PA ( Site 4413)
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接触：
- Study Coordinator
- 电话号码：843-572-8545
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Tennessee
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Chattanooga、Tennessee、美国、37421
- 招聘中
- M3 Wake Research, Inc. ( Site 4440)
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接触：
- Study Coordinator
- 电话号码：423-698-4584
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Texas
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Victoria、Texas、美国、77901
- 招聘中
- Victoria Clinical Research Group ( Site 4430)
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接触：
- Study Coordinator
- 电话号码：361-210-7869
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Inclusion Criteria include but are not limited to:
- Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization
- Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening
- Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening
- Is a current or former cigarette smoker with a history of cigarette smoking ≥10 packyears at Screening (number of pack-years = [number of cigarettes per day/20] × number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Pipe, cigar, and/or e-cigarette/vape use cannot be used to calculate pack-year history.
- Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and <70% of Predicted Normal Value
Exclusion Criteria:
Exclusion criteria include but are not limited to:
- Has a history of intubation for respiratory failure within 1 year of Screening
- Is receiving long-term oxygen therapy defined as >15 hours per day
- Uses chronic bilevel positive airway pressure for treatment of respiratory condition unless for treatment of sleep apnea at a stable pressure for at least 3 months
- Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit
- Has history of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ensifentrine
Participants, who meet the criteria of being on standard of care (SOC) background treatment receive ensifentrine twice a day (bid) by oral inhalation via a standard jet nebulizer for up to 52 weeks. |
Delivered twice daily by oral inhalation via a standard jet nebulizer
其他名称：
Background treatment of LAMA/LABA/ICS or LAMA/LABA (if ICS is not appropriate) administered per product approved label delivered by oral inhalation as part of standard of care |
|
安慰剂比较：Placebo
Participants, who meet the criteria of being on SOC background treatment receive placebo bid by oral inhalation via a standard jet nebulizer for up to 52 weeks. |
Background treatment of LAMA/LABA/ICS or LAMA/LABA (if ICS is not appropriate) administered per product approved label delivered by oral inhalation as part of standard of care Placebo matched to ensifentrine delivered twice daily by oral inhalation via a standard jet nebulizer |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
大体时间：Up to 52 Weeks
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The annualized rate of moderate or severe exacerbations over 52 weeks will be reported. |
Up to 52 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second Area Under the Curve From 0-4 Hours (FEV1 AUC0-4h)
大体时间：Baseline and Week 12
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FEV1 measures the volume of air exhaled during the first second of a forced exhalation maneuver from the point of maximal inspiration. FEV1 AUC0-4h represents the bronchodilator response over the 4-hour period following administration of study intervention. Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 AUC0-4h on Week 12 will be reported. |
Baseline and Week 12
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Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Responder Status
大体时间：Baseline and Week 24
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The SGRQ is a 50-item patient-reported outcome (PRO) questionnaire used to evaluate health-related quality of life (HRQOL) in patients with COPD. The questionnaire contains 3 domains: Symptoms (frequency and severity of respiratory symptoms), Activity (effect of disease on common daily physical activities), and Impacts (psychological effects of the disease). The recall period of the questionnaire is over the past 4 weeks. The total score ranges from 0 to 100, with lower scores indicating better health status. A clinically meaningful improvement in HRQOL, as measured by the SGRQ, is defined as a ≥4.0-point decrease in SGRQ total score. HRQOL, as measured by the percentage of SGRQ responders (≥4-point decrease) at Week 24 will be reported. |
Baseline and Week 24
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Annualized Rate of Adjudicated Severe COPD Exacerbations
大体时间：Up to 52 Weeks
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The annualized rate of adjudicated severe COPD exacerbations over 52 weeks will be reported. |
Up to 52 Weeks
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Number of Participants with at Least One Adverse Event (AE)
大体时间：Up to 53 weeks
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An AE is any untoward medical occurrence in a subject, temporally associated with the use of the study medication, whether or not considered related to the study medication. Number of participants who experience at least one AE will be reported. |
Up to 53 weeks
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Number of Participants who Discontinued Study Intervention Due to an Adverse Event
大体时间：Up to 52 Weeks
|
An AE is any untoward medical occurrence in a subject, temporally associated with the use of the study medication, whether or not considered related to the study medication. Number of participants who discontinue study intervention due to an AE will be reported. |
Up to 52 Weeks
|
合作者和调查者
调查人员
- 研究主任：Medical Director、Merck Sharp & Dohme LLC
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5884-031
- 2026-526255-61-00 (注册表标识符：EU CT)
- U1111-1337-6442 (注册表标识符：UTN)
- MK-5884-031 (其他标识符：MSD)
- RPL554 (其他标识符：Verona)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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