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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Toll Free Number
- Numero di telefono: 1-888-577-8839
- Email: Trialsites@msd.com
Luoghi di studio
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Florida
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Hialeah Gardens, Florida, Stati Uniti, 33016
- Reclutamento
- Family First Medical Research Center ( Site 4458)
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Contatto:
- Study Coordinator
- Numero di telefono: 786-665-9374
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Loxahatchee Groves, Florida, Stati Uniti, 33470
- Reclutamento
- Advanced Pulmonary Research Institute ( Site 4427)
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Contatto:
- Study Coordinator
- Numero di telefono: 561-603-6688
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Indiana
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Valparaiso, Indiana, Stati Uniti, 46383
- Reclutamento
- Velocity Clinical Research ( Site 4464)
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Contatto:
- Study Coordinator
- Numero di telefono: 219-464-8302
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New York
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The Bronx, New York, Stati Uniti, 10455
- Reclutamento
- CHEAR Center LLC ( Site 4407)
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Contatto:
- Study Coordinator
- Numero di telefono: 347-270-1111
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29406
- Reclutamento
- Lowcountry Lung & Critical Care, PA ( Site 4413)
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Contatto:
- Study Coordinator
- Numero di telefono: 843-572-8545
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37421
- Reclutamento
- M3 Wake Research, Inc. ( Site 4440)
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Contatto:
- Study Coordinator
- Numero di telefono: 423-698-4584
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Texas
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Victoria, Texas, Stati Uniti, 77901
- Reclutamento
- Victoria Clinical Research Group ( Site 4430)
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Contatto:
- Study Coordinator
- Numero di telefono: 361-210-7869
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
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 |
|
Comparatore placebo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second Area Under the Curve From 0-4 Hours (FEV1 AUC0-4h)
Lasso di tempo: Baseline and Week 12
|
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
Lasso di tempo: 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
Lasso di tempo: Up to 52 Weeks
|
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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie polmonari, ostruttive
- Condizioni patologiche, segni e sintomi
- Malattia polmonare, cronica ostruttiva
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Indicatori di qualità, assistenza sanitaria
- Standard di cura
- ensifentrine
Altri numeri di identificazione dello studio
- 5884-031
- 2026-526255-61-00 (Identificatore di registro: EU CT)
- U1111-1337-6442 (Identificatore di registro: UTN)
- MK-5884-031 (Altro identificatore: MSD)
- RPL554 (Altro identificatore: Verona)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
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