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A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

A Phase II, Randomized, Double-Blind, Cross-Over Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-Glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

NCT07132983•Verona Pharma plc

View on ClinicalTrials.gov

Summary

This study will assess the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the marketed formulation each administered via a standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).

Detailed Description

Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 5 single doses of study medication with each dose followed by an approximately 7-day washout period (total of 5 weeks), and 1 week of follow-up. Participants will be randomized to receive all the treatments in different sequences. The primary objective of the study is to evaluate the pharmacokinetics of the fixed-dose combination of ensifentrine and glycopyrrolate compared to each drug alone and to ensifentrine in a different formulation.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males are eligible to participate if they 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 and not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
•Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years as of signing the ICF \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. 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 the ICF. 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
•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 ≥ 40 % and ≤ 80% of predicted normal
•A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months prior to signing the 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
+5 more criteria

Exclusion Criteria

•Concomitant clinically significant pulmonary disease other than COPD (e.g., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure 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 therapies for a COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids; antibiotics; theophylline; 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)
•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, glycopyrrolate, any excipients/components of the study medications, anticholinergic agents, or sympathomimetic amines
+15 more criteria

Locations (4)

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, United States

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States

Midwest Chest Consultants PC

Saint Charles, Missouri, United States

Velocity Clinical Research - Spartanburg - PPDS

Spartanburg, South Carolina, United States

Key Dates

Start Date

October 6, 2025

Primary Completion Date

November 28, 2025

Completion Date

November 28, 2025

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Ensifentrine 3 mg

DRUG

Glycopyrrolate 42.5 mcg

DRUG

Ensifentrine 1.5 mg

DRUG

Ensifentrine 3 mg (marketed formulation)

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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