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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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Florida
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Hialeah Gardens, Florida, Forente stater, 33016
- Rekruttering
- Family First Medical Research Center ( Site 4458)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 786-665-9374
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Loxahatchee Groves, Florida, Forente stater, 33470
- Rekruttering
- Advanced Pulmonary Research Institute ( Site 4427)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 561-603-6688
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Indiana
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Valparaiso, Indiana, Forente stater, 46383
- Rekruttering
- Velocity Clinical Research ( Site 4464)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 219-464-8302
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New York
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The Bronx, New York, Forente stater, 10455
- Rekruttering
- CHEAR Center LLC ( Site 4407)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 347-270-1111
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South Carolina
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Charleston, South Carolina, Forente stater, 29406
- Rekruttering
- Lowcountry Lung & Critical Care, PA ( Site 4413)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 843-572-8545
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37421
- Rekruttering
- M3 Wake Research, Inc. ( Site 4440)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 423-698-4584
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Texas
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Victoria, Texas, Forente stater, 77901
- Rekruttering
- Victoria Clinical Research Group ( Site 4430)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 361-210-7869
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
Andre navn:
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 komparator: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Tidsramme: Up to 52 Weeks
|
The annualized rate of moderate or severe exacerbations over 52 weeks will be reported. |
Up to 52 Weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second Area Under the Curve From 0-4 Hours (FEV1 AUC0-4h)
Tidsramme: 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
Tidsramme: Baseline and Week 24
|
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
Tidsramme: 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)
Tidsramme: Up to 53 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 experience at least one AE will be reported. |
Up to 53 weeks
|
|
Number of Participants who Discontinued Study Intervention Due to an Adverse Event
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kronisk sykdom
- Sykdomsattributter
- Sykdommer i luftveiene
- Lungesykdommer
- Lungesykdommer, obstruktiv
- Patologiske tilstander, tegn og symptomer
- Lungesykdom, kronisk obstruktiv
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
- ensifentrine
Andre studie-ID-numre
- 5884-031
- 2026-526255-61-00 (Registeridentifikator: EU CT)
- U1111-1337-6442 (Registeridentifikator: UTN)
- MK-5884-031 (Annen identifikator: MSD)
- RPL554 (Annen identifikator: Verona)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
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