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

Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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:

‣ Not a woman of child-bearing potential OR

⁃ Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study

⁃ 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:

‣ FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND

⁃ 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

Locations
United States
Alabama
SEC Clinical Research, LLC
RECRUITING
Dothan
Arizona
Elite Clinical Studies, LLC
RECRUITING
Phoenix
California
Downtown LA Research Center Inc - ClinEdge
RECRUITING
Los Angeles
California Medical Research Associates, Inc.
RECRUITING
Northridge
Northern California Research Corp
RECRUITING
Sacramento
Florida
Clinical Research of West Florida Inc
RECRUITING
Clearwater
Fleming Island Center For Clinical Research
RECRUITING
Fleming Island
Florida Institute For Clinical Research LLC
RECRUITING
Orlando
Ormond Beach Clinical Research
RECRUITING
Ormond Beach
Progressive Medical Research
RECRUITING
Port Orange
Clinical Research of West Florida Inc - Tampa
RECRUITING
Tampa
Georgia
Centricity Research Columbus Georgia
RECRUITING
Columbus
Southeast Lung Associates Research
RECRUITING
Rincon
Indiana
ASHA Clinical Research - Hammond
RECRUITING
Hammond
Velocity Clinical Research - Valparaiso
RECRUITING
Valparaiso
Maryland
Velocity Clinical Research
RECRUITING
Rockville
Michigan
Revive Research Institute, Inc
RECRUITING
Southfield
Missouri
Midwest Clinical Research LLC
RECRUITING
St Louis
The Clinical Research Center LLC - CRN
RECRUITING
St Louis
North Carolina
American Health Research Inc
RECRUITING
Charlotte
Clinical Research of Gastonia
RECRUITING
Gastonia
Stern Research Partners, LLC
RECRUITING
Huntersville
Monroe Biomedical Research -343 Venus St
RECRUITING
Monroe
Carolina Research Center, Inc
RECRUITING
Shelby
New Jersey
Trialfinity Clinical Research Center
RECRUITING
Hamilton
Nevada
Sierra Clinical Research
RECRUITING
Las Vegas
New York
Horizon Family Medical Group
RECRUITING
New Windsor
Ohio
Remington Davis Clinical Research
RECRUITING
Columbus
Advance Clinical Research
RECRUITING
Dayton
South Carolina
Velocity Clinical Research - Anderson - PPDS
RECRUITING
Anderson
Pharmacorp Clinical Trials Incorporated
RECRUITING
Charleston
Piedmont Research Partners LLC
RECRUITING
Fort Mill
Velocity Clinical Research - Gaffney - PPDS
RECRUITING
Gaffney
Lowcountry Lung and Critical Care PA
RECRUITING
North Charleston
Monroe Biomedical Research Charleston
RECRUITING
North Charleston
Clinical Research of Rock Hill
RECRUITING
Rock Hill
Spartanburg Medical Research
RECRUITING
Spartanburg
Velocity Clinical Research - Union
RECRUITING
Union
Tennessee
Chattanooga Research & Medicine
RECRUITING
Chattanooga
ClinSearch - Chattanooga
RECRUITING
Chattanooga
Clinical Trials Center of Middle Tennessee
RECRUITING
Franklin
MultiSpecialty Clinical Research, Inc
RECRUITING
Johnson City
Texas
Inquest Clinical Research
RECRUITING
Baytown
Corsicana Medical Research
RECRUITING
Corsicana
Houston Pulmonary Sleep & Allergy Associates
RECRUITING
Cypress
Greater Heights Memorial Pulmonary and Sleep
RECRUITING
Houston
Houston Pulmonary Medicine Associates, PA
RECRUITING
Houston
Huntsville Research Institute LLC
RECRUITING
Huntsville
Element Research Group
RECRUITING
San Antonio
Sherman Clinical Research
RECRUITING
Sherman
Tranquil Clinical Research
RECRUITING
Webster
Contact Information
Primary
Verona Pharma Clinical Trials
clinicaltrials@veronapharma.com
Please reach out by email
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2026-04-29
Participants
Target number of participants: 480
Treatments
Experimental: Treatment Arm A: Ensifentrine plus Glycopyrrolate
Ensifentrine 3 mg / Glycopyrrolate 42.5 mcg
Experimental: Treatment Arm B: Ensifentrine plus Glycopyrrolate
Ensifentrine 3 mg / Glycopyrrolate 21.25 mcg
Active_comparator: Treatment Arm C: Glycopyrrolate
Glycopyrrolate monotherapy 42.5 mcg
Active_comparator: Treatment Arm D: Glycopyrrolate
Glycopyrrolate monotherapy 21.25 mcg
Active_comparator: Treatment Arm E: Ensifentrine
Ensifentrine monotherapy 3 mg
Placebo_comparator: Treatment Arm F: Placebo
Placebo
Sponsors
Leads: Verona Pharma plc

This content was sourced from clinicaltrials.gov