Completed

Effects of Ensifentrine on COPD Symptoms in Moderate to Severe COPD Patients

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Study Aim

This study aims to evaluate the effects of Ensifentrine on symptoms of Chronic Obstructive Pulmonary Disease (COPD) in patients with moderate to severe conditions, by measuring improvements in the COPD Assessment Test (CAT) score after 12 weeks of treatment.

What is being tested

Ensifentrine 3 mg twice daily

Drug
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 40 to 80 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorVerona Pharma plc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 11, 2024

Actual date on which the first participant was enrolled.

This study explores the impact of the medication ensifentrine on symptoms of Chronic Obstructive Pulmonary Disease (COPD) in individuals with moderate to severe forms of the condition. Participants in this study include those who are already using maintenance treatments like LAMA/LABA or LAMA/LABA/ICS therapies. The main goal is to see how ensifentrine, a medication given via a nebulizer, can improve the scores on the COPD Assessment Test (CAT™), which measures the severity of COPD symptoms, over a 12-week period. Participants in this trial will receive ensifentrine twice a day through a nebulizer, in addition to their regular maintenance medication. The study will monitor changes in their COPD symptoms using the CAT™ scores to evaluate the effectiveness of ensifentrine. This trial does not mention specific risks or benefits, but aims to provide insights into whether ensifentrine can offer additional relief from COPD symptoms beyond current treatments.

Official TitleA Study Assessing the Effect of Ensifentrine on CAT™ Scores Over 12 Weeks in Subjects With Moderate to Severe COPD
NCT06460493
Principal SponsorVerona Pharma plc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

9 inclusion criteria required to participate
Capable of giving informed consent.
Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years.
Established clinical history of moderate to severe COPD.
Pre- and post-albuterol FEV1/FVC ratio of < 0.70.
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24 exclusion criteria prevent from participating
Women who are breast feeding.
Hospitalizations for COPD (or COPD exacerbation), pneumonia, or other serious infection or treatment with oral or parenteral (oral, intravenous, or intramuscular) glucocorticoids within the past 12 weeks.
Lower respiratory tract infection within the past 6 weeks or an active infection.
History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation within 1-year.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Midwest Chest Consultants

Saint Charles, United StatesOpen Midwest Chest Consultants in Google Maps
CompletedOne Study Center