RecruitingPhase 2NCT07016412

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

Sponsor

Verona Pharma plc

Enrollment

480 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease

Summary

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a new fixed-dose combination inhaler containing ensifentrine and glycopyrrolate to find the most effective and safe dose for treating COPD (chronic obstructive pulmonary disease), a lung condition that makes breathing difficult. **You may be eligible if...** - You are an established smoker or ex-smoker (at least 10 pack-years) with a clinical diagnosis of COPD - Your breathing tests confirm COPD (specific lung function thresholds) - You experience significant shortness of breath in your daily life (mMRC score ≥2) - You have had a chest X-ray or CT scan within the past 12 months with no major unexpected findings **You may NOT be eligible if...** - You have been diagnosed with asthma or another major lung disease besides COPD - You are currently hospitalized for a COPD flare-up or have had a severe flare requiring hospitalization in the past 3 months - You have uncontrolled serious heart conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnsifentrine 3 mg

Administered by a standard jet nebulizer, twice daily for 28 consecutive days

DRUGGlycopyrrolate 21.25 mcg

Administered by a standard jet nebulizer, twice daily for 28 consecutive days

DRUGGlycopyrrolate 42.5 mcg

Administered by a standard jet nebulizer, twice daily for 28 consecutive days

DRUGPlacebo

Administered by a standard jet nebulizer, twice daily for 28 consecutive days

Locations(55)

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 Multispecialty - PPDS

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) - PPDS

Rockville, Maryland, United States

Revive Research Institute, Inc

Southfield, Michigan, United States

Midwest Chest Consultants PC

Saint Charles, Missouri, 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 Primary Care

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

Kettering, Ohio, United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 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

Spartanburg, South Carolina, United States

Velocity Clinical Research - Union - PPDS

Union, South Carolina, United States

Chattanooga Research & Medicine, PLLC

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

Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS

Cypress, Texas, United States

Greater Heights Memorial Pulmonary and Sleep

Houston, Texas, United States

Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS

Houston, Texas, United States

Huntsville Research Institute LLC

Huntsville, Texas, United States

Element Research Group

San Antonio, Texas, United States

Sherman Clinical Research - 403 N. Highland Ave

Sherman, Texas, United States

Tranquil Clinical Research

Webster, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07016412

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