Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Effect of Ensifentrine (MK-5884/RPL554) on Sputum Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD) (MK-5884-023/RPL554-CO-207)

29 października 2026 zaktualizowane przez: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

A Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Subjects With COPD

Researchers are looking for new ways to treat chronic obstructive pulmonary disease (COPD). COPD is a long-lasting swelling of the airways that makes it hard to breathe. Researchers want to learn if a trial medicine called ensifentrine can help treat sputum caused by COPD. In this trial, researchers will compare a trial medicine called ensifentrine to a placebo. A placebo looks like the trial medicine but has no medicine in it. Using a placebo helps researchers better understand the effects of a trial medicine.

The goal of this trial is to learn about the effect of ensifentrine on a substance found in mucus (sputum) from the lungs that may be a sign of inflammation in participants with COPD.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

70

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35205
        • University of Alabama at Birmingham
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • University of Pittsburgh Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Participants with a history of cigarette smoking ≥10 pack years and an established clinical history of chronic obstructive pulmonary disease (COPD) as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD. 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]
  • COPD Severity: Pre- and Post-albuterol/salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of <0.70; Post-albuterol/salbutamol FEV1 ≥30 % and ≤80% of predicted normal calculated using the National Health and Nutrition Examination Survey III
  • Regular use of bronchodilator COPD therapy, in any form (e.g., [Long-acting muscarinic antagonist] LAMA, [Long-acting β2-agonist] LABA, LAMA+LABA, LAMA+LABA+ [Inhaled corticosteroid(s)] ICS), for at least 4 weeks prior to Screening and agrees to use study supplied COPD Maintenance Therapy once daily through the final study visit
  • Capable of using the jet nebulizer correctly and complying with all study restrictions and procedures
  • Ability to perform acceptable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
  • Ability to produce sputum samples during the induced sputum procedure

Exclusion Criteria:

  • Any clinically diagnosed lung disease other than COPD such as current asthma, diffuse interstitial lung diseases, cystic fibrosis, or clinically significant bronchiectasis as determined by the Investigator
  • Hospitalizations for COPD exacerbation, pneumonia, or other respiratory infection in the 12 weeks prior to Screening.
  • Alanine aminotransferase (ALT) ≥ 2 x upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • Human immunodeficiency virus (HIV) infection or other immunodeficiency
  • History of cancer within the last 5 years, except for well-treated basal cell carcinoma and squamous cell carcinoma of the skin
  • Any clinically significant 12-lead electrocardiogram abnormalities at screening or baseline, including corrected QT interval by Fridericia's correction method >450 ms for males or >480 ms for females or history of significant cardiac dysrhythmia, including long QT syndrome
  • Known history of poor outcomes with sputum induction
  • Known hypersensitivity to ensifentrine or other medications used in the study (e.g., albuterol or salmeterol)
  • Not suitable for study supplied once daily COPD Maintenance Therapy per label warnings and contraindications
  • Taking prohibited medication
  • Prior receipt of Ohtuvayre or blinded nebulized study medication in an ensifentrine (RPL554) study. Note: Other ensifentrine formats (e.g., DPI, MPI) are not exclusionary
  • Use of an experimental drug within 30 days or 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical trial within 30 days prior to Screening
  • Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical trial within 30 days prior to Screening
  • Any other medical history, chronic uncontrolled diseases that the investigator considers clinically significant, examination or laboratory findings or reason that the Investigator considers makes the patient unsuitable to participate at Screening

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ensifentrine Sequence 1

In treatment period 1 participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 1 participants will receive LABA/LAMA background therapy.
Lek: Ensifentrine

Ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.

Lek: Placebo

Placebo matching ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.

Lek: LABA/LAMA

Background treatment of LAMA/LABA administered per product approved label delivered by oral inhalation.

Inne nazwy:
  • Anoro®
Eksperymentalny: Ensifentrine Sequence 2

In treatment period 1 participants will receive placebo matching ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks followed by treatment period 2 during which participants will receive 3 mg ensifentrine twice daily administered via a standard jet nebulizer for 8 weeks. Throughout treatment sequence 2 participants will receive LABA/LAMA background therapy.
Lek: Ensifentrine

Ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.

Lek: Placebo

Placebo matching ensifentrine administered twice daily by oral inhalation via a standard jet nebulizer.

Lek: LABA/LAMA

Background treatment of LAMA/LABA administered per product approved label delivered by oral inhalation.

Inne nazwy:
  • Anoro®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The Absolute Change From Baseline in Sputum Neutrophil Cell Numbers
Ramy czasowe: Baseline and 8 Weeks

The Absolute change from baseline in sputum neutrophil cell numbers will be reported.
Baseline and 8 Weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Absolute Change in Cell Numbers From Baseline in Sputum Cell Counts
Ramy czasowe: Baseline and 8 Weeks

Absolute change in cell numbers from baseline in sputum cell counts (eosinophils, basophils, macrophages, lymphocytes, total cells) will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Sputum Cell Counts
Ramy czasowe: Baseline and 8 Weeks

Percent change from baseline in sputum cell counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes, and total cells) will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Cytokines
Ramy czasowe: Baseline and 8 Weeks

Percent Change From Baseline in Cytokines will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Proteases
Ramy czasowe: Baseline and 8 Weeks

Percent Change From Baseline in Proteases will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Markers of Inflammation
Ramy czasowe: Baseline and 8 Weeks

Percent Change From Baseline in Markers of Inflammation will be reported.
Baseline and 8 Weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in FEV1 at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Baseline and 4 Weeks
Change From Baseline in FEV1 at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in FEV1 at 8 weeks during the treatment period (postdose) will be reported.
Baseline and 8 Weeks
Change From Baseline in Forced Vital Capacity (FVC) at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in FVC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Baseline and 4 Weeks
Change From Baseline in FVC at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in FVC at 8 weeks during the treatment period (postdose) will be reported.
Baseline and 8 Weeks
Change From Baseline in Residual Volume (RV) at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in RV at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Baseline and 4 Weeks
Change From Baseline in RV at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in RV at 8 weeks (postdose) during the treatment period will be reported.
Baseline and 8 Weeks
Change From Baseline in Functional Residual Capacity (FRC) at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in FRC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Baseline and 4 Weeks
Change From Baseline in FRC at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in FRC at 8 weeks (postdose) during the treatment period will be reported.
Baseline and 8 Weeks
Change From Baseline in Total Lung Capacity (TLC) at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in TLC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
Baseline and 4 Weeks
Change From Baseline in TLC at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in TLC at 8 weeks (postdose) during the treatment period will be reported.
Baseline and 8 Weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
Ramy czasowe: Up to approximately 8 Weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Number of participants who experience one or more adverse events will be reported.
Up to approximately 8 Weeks
Change From Baseline in Systolic Blood Pressure
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in systolic blood pressure will be reported.
Baseline and 8 Weeks
Change From Baseline in Diastolic Blood Pressure
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in diastolic blood pressure will be reported.
Baseline and 8 Weeks
Change From Baseline in Heart Rate
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in heart rate will be reported.
Baseline and 8 Weeks
Change From Baseline in QRS Duration
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in QRS duration will be reported.
Baseline and 8 Weeks
Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in QTcF will be reported.
Baseline and 8 Weeks
Change From Baseline in QT Interval
Ramy czasowe: Baseline and 8 Weeks

Change from baseline for in QT interval will be reported.
Baseline and 8 Weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Absolute Blood Cell Counts at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change from baseline in absolute blood cell counts at 4 weeks will be reported.
Baseline and 4 Weeks
Change From Baseline in Cytokines at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change From Baseline in Cytokines at 4 Weeks will be reported.
Baseline and 4 Weeks
Change From Baseline in Proteases at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change From Baseline in Proteases at 4 Weeks will be reported.
Baseline and 4 Weeks
Change From Baseline in Markers of Inflammation at 4 Weeks
Ramy czasowe: Baseline and 4 Weeks

Change From Baseline in Markers of Inflammation at 4 Weeks will be reported.
Baseline and 4 Weeks
Change From Baseline in Absolute Blood Cell Counts at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in absolute blood cell counts at 8 weeks will be reported.
Baseline and 8 Weeks
Change From Baseline in Cytokines at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in cytokines at 8 weeks will be reported.
Baseline and 8 Weeks
Change From Baseline in Proteases at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in proteases at 8 weeks will be reported.
Baseline and 8 Weeks
Change From Baseline in Blood Markers of Inflammation at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Change from baseline in blood markers of inflammation at 8 weeks will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Sputum Acetylated Proline-Glycine-Proline (AcPGP) at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Percent change from baseline in sputum Acetylated Proline-Glycine-Proline (AcPGP) at 8 weeks will be reported.
Baseline and 8 Weeks
Percent Change From Baseline in Sputum Proline-Glycine-Proline (PGP) at 8 Weeks
Ramy czasowe: Baseline and 8 Weeks

Percent change from baseline in sputum PGP at 8 weeks will be reported.
Baseline and 8 Weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Współpracownicy

University of Alabama at Birmingham

Śledczy

  • Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

27 maja 2022

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

8 lutego 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 lutego 2022

Pierwszy wysłany (Rzeczywisty)

8 marca 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RPL554-CO-207
  • MK-5884-023 (Inny identyfikator: MSD)
  • RPL554-CO-207 (Inny identyfikator: VeronaPharma)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj