A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
NCT ID: NCT07016412
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
480 participants
INTERVENTIONAL
2025-07-31
2026-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Arm A: Ensifentrine plus Glycopyrrolate
Ensifentrine 3 mg / Glycopyrrolate 42.5 mcg
Ensifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Glycopyrrolate 42.5 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Treatment Arm B: Ensifentrine plus Glycopyrrolate
Ensifentrine 3 mg / Glycopyrrolate 21.25 mcg
Ensifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Glycopyrrolate 21.25 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Treatment Arm C: Glycopyrrolate
Glycopyrrolate monotherapy 42.5 mcg
Glycopyrrolate 42.5 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Treatment Arm D: Glycopyrrolate
Glycopyrrolate monotherapy 21.25 mcg
Glycopyrrolate 21.25 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Treatment Arm E: Ensifentrine
Ensifentrine monotherapy 3 mg
Ensifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Treatment Arm F: Placebo
Placebo
Placebo
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Interventions
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Ensifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Glycopyrrolate 21.25 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Glycopyrrolate 42.5 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Placebo
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects 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
* Subjects on no maintenance/background therapy or subjects 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. Subjects 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
* 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 subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject
* 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 subject 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 (subjects 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
40 Years
80 Years
ALL
No
Sponsors
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Verona Pharma plc
INDUSTRY
Responsible Party
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Locations
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SEC Clinical Research, LLC
Dothan, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Downtown LA Research Center Inc - ClinEdge
Los Angeles, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Northern California Research Corp
Sacramento, California, United States
Clinical Research of West Florida Inc
Clearwater, Florida, United States
Fleming Island Center For Clinical Research
Fleming Island, Florida, United States
Florida Institute For Clinical Research LLC
Orlando, Florida, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States
Centricity Research Columbus Georgia
Columbus, Georgia, United States
Southeast Lung Associates Research
Rincon, Georgia, United States
ASHA Clinical Research - Hammond
Hammond, Indiana, United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, United States
Velocity Clinical Research
Rockville, Maryland, United States
Revive Research Institute, Inc
Southfield, Michigan, United States
Midwest Clinical Research LLC
St Louis, Missouri, United States
The Clinical Research Center LLC - CRN
St Louis, Missouri, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Trialfinity Clinical Research Center
Hamilton, New Jersey, United States
Horizon Family Medical Group
New Windsor, New York, United States
American Health Research Inc
Charlotte, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Stern Research Partners, LLC
Huntersville, North Carolina, United States
Monroe Biomedical Research -343 Venus St
Monroe, North Carolina, United States
Carolina Research Center, Inc
Shelby, North Carolina, United States
Remington Davis Clinical Research
Columbus, Ohio, United States
Advance Clinical Research
Dayton, Ohio, United States
Velocity Clinical Research - Anderson - PPDS
Anderson, South Carolina, United States
Pharmacorp Clinical Trials Incorporated
Charleston, South Carolina, United States
Piedmont Research Partners LLC
Fort Mill, South Carolina, United States
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, United States
Lowcountry Lung and Critical Care PA
North Charleston, South Carolina, United States
Monroe Biomedical Research Charleston
North Charleston, South Carolina, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Velocity Clinical Research - Union
Union, South Carolina, United States
Chattanooga Research & Medicine
Chattanooga, Tennessee, United States
ClinSearch - Chattanooga
Chattanooga, Tennessee, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
MultiSpecialty Clinical Research, Inc
Johnson City, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
Corsicana Medical Research
Corsicana, Texas, United States
Houston Pulmonary Sleep & Allergy Associates
Cypress, Texas, United States
Greater Heights Memorial Pulmonary and Sleep
Houston, Texas, United States
Houston Pulmonary Medicine Associates, PA
Houston, Texas, United States
Huntsville Research Institute LLC
Huntsville, Texas, United States
Element Research Group
San Antonio, Texas, United States
Sherman Clinical Research
Sherman, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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RPL554-CO-212
Identifier Type: -
Identifier Source: org_study_id
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