New combo inhaler aims to improve breathing in COPD patients

NCT ID NCT07016412

Disease control Sponsor: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests a new fixed-dose combination of two drugs (ensifentrine and glycopyrrolate) given via nebulizer twice daily for 28 days in 480 adults with COPD. The goal is to see if the combination improves lung function more than either drug alone or placebo. The trial is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ensifentrine and glycopyrrolate combination
What this could lead to: If successful, this could lead to a new treatment option that helps people with COPD breathe better.
What could go wrong: This is an early Phase 2b trial with only 480 participants over 28 days. The combination may not work better than existing treatments, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

497 people

The number who actually took part.

Started

Jul 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study * Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply: 1. Not a woman of child-bearing potential OR 2. Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study 3. Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study * Current of former cigarette smokers with a history of smoking ≥ 10 pack years at the time of signing informed consent \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Pipe 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 signing informed consent. Smoking cessation programs are permitted during the study * Participants with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD * A score of ≥ 2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at the Screening Visit * Post-bronchodilator (4 puffs of albuterol) spirometry during the Screening Period demonstrating both the following: 1. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND 2. FEV1 ≥ 30 % and ≤ 70% of predicted normal * A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months of signing the Informed Consent Form (ICF) showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR * Participants on no maintenance/background therapy or participants on stable maintenance as either long-acting β2-agonist (LABA) or long-acting β2-agonist/Inhaled corticosteroid (LABA/ICS) therapy are eligible. Subjects taking maintenance therapy must demonstrate regular use of maintenance therapy, in any form, for at least 60 days prior to signing informed consent and agree to continue use of their current permitted LABA or LABA/ICS medication for the duration of the screening and treatment period * Capable of withholding from short-acting bronchodilators for 4 hours prior to spirometry testing. Participants receiving maintenance therapy with a LABA or LABA/ICS must be capable of withholding twice-daily maintenance therapy for 24 hours and once-daily maintenance therapy for 48 hours prior to initiation of any spirometry * Capable of using the study jet nebulizer correctly * Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines * Willing and able to attend all study visits and adhere to all study assessments and procedures Exclusion Criteria: * Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure \[CPAP\] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease * Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization * Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast) * History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation * Severe comorbidities including 1. unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3 months prior to randomization, diagnosis of New York Heart Association (NYHA) class III or IV heart disease, or 2. any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric \[e.g. untreated significant depression, anxiety or history of suicidality\], or ophthalmic diseases) that would, in the opinion of the Investigator, preclude the participant from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the participant * History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within 6 months prior to randomization * History of narrow angle glaucoma * History of hypersensitivity or intolerance to aerosol medications, albuterol, ensifentrine, or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines * History of or current malignancy of any organ system, treated or untreated within the 5 years prior to randomization, except for localized basal or squamous cell carcinoma of the skin * Other significant psychiatric disease that would likely result in the participant not being able to complete the study, in the opinion of the Investigator * Findings on physical examination that an investigator considers to be clinically significant or abnormal during the Screening Period including hematology, biochemistry, viral serology, and ECG * Prior or current use of Ohtuvayre (ensifentrine) * Previous lung resection or lung reduction surgery within 1-year of randomization * 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 stable from 4 weeks prior to signing the ICF and plans to remain stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study * Major surgery (requiring general anesthesia) in the 6 weeks prior randomization, lack of full recovery from surgery at randomization, or planned surgery through the end of the study * Current or history of drug or alcohol abuse within the 5 years prior to randomization * Estimated glomerular filtration rate (eGFR) \< 30 mL/min as tested during the Screening Period * Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or total bilirubin \> 1.5 × ULN (participants with Gilbert's syndrome can be included with total bilirubin \>1.5 × ULN as long as direct bilirubin is ≤ 1.5 × ULN) * Use of an experimental drug within 30 days or 5 half-lives of signing the ICF, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to signing the ICF * Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to informed consent * Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

Contacts and locations

Locations

ASHA Clinical Research - Hammond

Hammond, Indiana, 46324, United States
Advance Clinical Research

Kettering, Ohio, 45439, United States
American Health Research Inc

Charlotte, North Carolina, 28277, United States
Bernstein Clinical Research Center Inc

Cincinnati, Ohio, 45231-4927, United States
California Medical Research Associates, Inc.

Northridge, California, 91324-6200, United States
Carolina Research Center, Inc

Shelby, North Carolina, 28150-3803, United States
Centricity Research Columbus Georgia Multispecialty - PPDS

Columbus, Georgia, 31904, United States
Chattanooga Research & Medicine, PLLC

Chattanooga, Tennessee, 37404, United States
ClinSearch - Chattanooga

Chattanooga, Tennessee, 37421, United States
Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801-2277, United States
Clinical Research Institute, Inc - CRN

Plymouth, Minnesota, 55441-2676, United States
Clinical Research of Gastonia

Gastonia, North Carolina, 28054-7481, United States
Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States
Clinical Research of West Florida Inc

Clearwater, Florida, 33765, United States
Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606, United States
Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067-5665, United States
Corsicana Medical Research

Corsicana, Texas, 75110-2471, United States
Downtown LA Research Center Inc - ClinEdge

Los Angeles, California, 90017, United States
Element Research Group

San Antonio, Texas, 78258, United States
Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States
Fleming Island Center For Clinical Research

Fleming Island, Florida, 32003, United States
Florida Institute For Clinical Research LLC

Orlando, Florida, 32825-4454, United States
Greater Heights Memorial Pulmonary and Sleep

Houston, Texas, 77008, United States
Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS

Cypress, Texas, 77429, United States
Horizon Family Medical Group - New Windsor Primary Care

New Windsor, New York, 12553-7754, United States
Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS

Houston, Texas, 77089, United States
Huntsville Research Institute LLC

Huntsville, Texas, 77340, United States
Inquest Clinical Research

Baytown, Texas, 77521, United States
Lowcountry Lung and Critical Care PA

North Charleston, South Carolina, 29406, United States
Midwest Chest Consultants PC

Saint Charles, Missouri, 63301, United States
Midwest Clinical Research LLC

St Louis, Missouri, 63141-7051, United States
Monroe Biomedical Research -343 Venus St

Monroe, North Carolina, 28112-4025, United States
Monroe Biomedical Research Charleston

North Charleston, South Carolina, 29406, United States
MultiSpecialty Clinical Research, Inc

Johnson City, Tennessee, 37604, United States
Northern California Research Corp

Sacramento, California, 95821-2640, United States
Ormond Beach Clinical Research

Ormond Beach, Florida, 32174-8196, United States
Pharmacorp Clinical Trials Incorporated

Charleston, South Carolina, 29412, United States
Piedmont Research Partners LLC

Fort Mill, South Carolina, 29707-4514, United States
Progressive Medical Research

Port Orange, Florida, 32127-5169, United States
Remington Davis Clinical Research

Columbus, Ohio, 43215, United States
Revive Research Institute, Inc

Southfield, Michigan, 48075, United States
SEC Clinical Research, LLC

Dothan, Alabama, 36305-7375, United States
Sherman Clinical Research - 403 N. Highland Ave

Sherman, Texas, 75092, United States
Sierra Clinical Research

Las Vegas, Nevada, 89106, United States
Spartanburg Medical Research

Spartanburg, South Carolina, 29303-4755, United States
Stern Research Partners, LLC

Huntersville, North Carolina, 28078, United States
The Clinical Research Center LLC - CRN

St Louis, Missouri, 63141, United States
Tranquil Clinical Research

Webster, Texas, 77598-4085, United States
Trialfinity Clinical Research Center

Hamilton, New Jersey, 08619, United States
Tucson Clinical Research Institute

Tucson, Arizona, 85712, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
Velocity Clinical Research

Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland, 20854-2960, United States
Velocity Clinical Research - Anderson - PPDS

Anderson, South Carolina, 29621-4822, United States
Velocity Clinical Research - Gaffney - PPDS

Gaffney, South Carolina, 29340-4737, United States
Velocity Clinical Research - Union - PPDS

Union, South Carolina, 29379, United States
Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

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