A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Key facts

Study ID

NCT04542057

Run by

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

People needed

790

Starts

2020-09-22

Expected to finish

2022-07-06

Last updated by the study team

2023-10-16

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent
• Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF).
• Age and Sex
• Age: Patient must be 40 to 80 years of age inclusive, at the time of Screening.
• Sex:
• Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
• Females are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions apply:
• Not a woman of childbearing potential (WOCBP). Or
• A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
• Smoking History
• Smoking History: Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 0. Smoking cessation programs are permitted during the study.
• COPD Diagnosis, Symptoms, Severity and Maintenance Therapy
• COPD Diagnosis: Patients with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli BR, 2004) with symptoms compatible with COPD.
• COPD Symptoms: A score of ≥2 on the Modified Medical Research Council (mMRC) Dyspnea Scale.
• COPD Severity:
• Pre- and Post-albuterol/salbutamol FEV1/FVC ratio of <0.70.
• Post-albuterol/salbutamol FEV1 ≥30 % and ≤70% of predicted normal calculated using the National Health and Nutrition Examination Survey III.
• Maintenance Therapy: Patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy are eligible. Patients taking maintenance LAMA or LABA therapy must demonstrate stable use of the maintenance LAMA or LABA therapy for at least 3 months prior to Screening and agree to continue use for the duration of the study. Background maintenance LAMA or LABA bronchodilator therapy will be capped at 50% of patients.
• Other Requirements for Inclusion
• Capable of withholding SABAs for 4 hours prior to initiation of any spirometry. Patients in the maintenance LAMA or LABA therapy stratum must be capable of withholding Twice-Daily maintenance LAMA or LABA for 24 hours and Once-Daily maintenance LAMA or LABA for 48 hours prior to initiation of any spirometry.
• Capable of using the study nebulizer correctly and complying with all study restrictions and procedures.
• Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines.
• Randomization Criteria Criteria for Inclusion at Randomization
• Symptoms of COPD: A score of ≥2 on the mMRC Dyspnea Scale.
• Completion of the e-Diary at least 5 of the last 7 days of the Run-in period.

You may not qualify if…

• Current Condition or Medical History
• History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
• Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active infection at Screening. Patients with COVID-19 antibodies from a previous exposure with no active infection are not excluded.
• COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening.
• Previous lung resection or lung reduction surgery within 1-year of Screening.
• Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤12 hours per day) is not exclusionary.
• Pulmonary rehabilitation, unless such treatment has been in a stable maintenance phase for 4 weeks prior to Visit 1 and remains stable during the study.
• Lower respiratory tract infection within 6 weeks of Screening.
• Other respiratory disorders including, but not limited to, a current diagnosis of asthma, active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, interstitial lung diseases, unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
• Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
• Historical or current evidence of clinically significant cardiovascular disease defined as any disease that in the opinion of the Investigator would put the safety of the patient at risk through participation or which could affect the efficacy or safety analysis if the disease/condition were to exacerbate during the study, including, but not limited to:
• Myocardial infarction or unstable angina within 6 months prior to Screening.
• Unstable or life-threatening cardiac arrhythmia requiring intervention within 3 months prior to Screening.
• Diagnosis of New York Heart Association Class III and Class IV heart failure.
• Chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant.
• Unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
• 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.
• Findings on physical examination that an investigator considers to be clinically significant at Screening.
• Prior/Concomitant Therapy
• Use of prohibited medications within the time intervals
• History or Suspicion of Drug or Alcohol Abuse
• Current or history of past drug or alcohol abuse within the past 5 years.
• Laboratory and Other Diagnostic Parameters
• Glomerular Filtration Rate (eGFR) <30 mL/min. The Chronic Kidney Disease Epidemiology Collaboration Creatinine (2009) calculation will be used.
• 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%).

Where it is running

• SEC Clinical Research — Andalusia, Alabama, United States
• Jasper Summit Research LLC — Jasper, Alabama, United States
• Pulmonary Associates Clinical Trials — Phoenix, Arizona, United States
• Elite Clinical Studies LLC — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Sun City West, Arizona, United States
• Premier Medical Group — Bakersfield, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• Downtown LA Research Center, Inc. — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• California Medical Research Associates — Northridge, California, United States
• Center for Clinical Trials of Sacramento, Inc. — Sacramento, California, United States
• Integrated Research Center — San Diego, California, United States
• Institute of HealthCare Assessment, Inc. — San Diego, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Medical Research of Central Florida — Leesburg, Florida, United States
• Axcess Medical Research — Loxahatchee Groves, Florida, United States
• Research Institute of South Florida — Miami, Florida, United States
• Advanced Medical Research Institute — Miami, Florida, United States
• Clinical Trials of Florida. LLC — Miami, Florida, United States
• South Medical Research Group, Inc. — Miami, Florida, United States
• Wright Clinical Research, LLC — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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