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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.com
연구 장소
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Florida
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Hialeah Gardens, Florida, 미국, 33016
- 모병
- Family First Medical Research Center ( Site 4458)
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연락하다:
- Study Coordinator
- 전화번호: 786-665-9374
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Loxahatchee Groves, Florida, 미국, 33470
- 모병
- Advanced Pulmonary Research Institute ( Site 4427)
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연락하다:
- Study Coordinator
- 전화번호: 561-603-6688
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Indiana
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Valparaiso, Indiana, 미국, 46383
- 모병
- Velocity Clinical Research ( Site 4464)
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연락하다:
- Study Coordinator
- 전화번호: 219-464-8302
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New York
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The Bronx, New York, 미국, 10455
- 모병
- CHEAR Center LLC ( Site 4407)
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연락하다:
- Study Coordinator
- 전화번호: 347-270-1111
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South Carolina
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Charleston, South Carolina, 미국, 29406
- 모병
- Lowcountry Lung & Critical Care, PA ( Site 4413)
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연락하다:
- Study Coordinator
- 전화번호: 843-572-8545
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Tennessee
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Chattanooga, Tennessee, 미국, 37421
- 모병
- M3 Wake Research, Inc. ( Site 4440)
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연락하다:
- Study Coordinator
- 전화번호: 423-698-4584
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Texas
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Victoria, Texas, 미국, 77901
- 모병
- Victoria Clinical Research Group ( Site 4430)
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연락하다:
- Study Coordinator
- 전화번호: 361-210-7869
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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 |
|
위약 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Forced Expiratory Volume in One Second Area Under the Curve From 0-4 Hours (FEV1 AUC0-4h)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 5884-031
- 2026-526255-61-00 (레지스트리 식별자: EU CT)
- U1111-1337-6442 (레지스트리 식별자: UTN)
- MK-5884-031 (기타 식별자: MSD)
- RPL554 (기타 식별자: Verona)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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