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A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD

NCT04535986•Verona Pharma plc

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of ensifentrine in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed Consent
•1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF).
•Age and Sex
•2. Age: Patient must be 40 to 80 years of age inclusive, at the time of Screening.
•3. Sex:
•* Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
•* Females are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions apply:
•1. Not a woman of childbearing potential (WOCBP) as defined in Or
•2. A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
•Smoking History
+14 more criteria

Exclusion Criteria

•Current Condition or Medical History
•1. History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
•2. Hospitalizations for COPD, pneumonia, or Corona Virus Disease 2019 (COVID-19) in the 12 weeks prior to Screening and/or a positive COVID-19 test result indicating an active infection at Screening. Patients with COVID-19 antibodies from a previous exposure with no active infection are not excluded.
•3. COPD exacerbation requiring oral or parenteral steroids within 3 months of Screening.
•4. Previous lung resection or lung reduction surgery within 1-year of Screening.
•5. 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.
•6. Pulmonary rehabilitation, unless such treatment has been in a stable maintenance phase for 4 weeks prior to Visit 1 and remains stable during the study.
•7. Lower respiratory tract infection within 6 weeks of Screening.
•8. Other respiratory disorders including, but not limited to, a current diagnosis of asthma, active tuberculosis, lung cancer, sarcoidosis, lung fibrosis, interstitial lung diseases, unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary diseases.
•9. Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
+31 more criteria

Locations (122)

Phoenix Medical Group

Peoria, Arizona, United States

AMR Tempe

Tempe, Arizona, United States

Beach Physicians Medical Group

Huntington Beach, California, United States

Downtown LA Research Center, Inc.

Los Angeles, California, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

St. Francis Medical Institute

Clearwater, Florida, United States

Qway Research, LLC

Hialeah, Florida, United States

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

Elite Clinical Research

Miami, Florida, United States

Global Research Solutions Corp

Miami, Florida, United States

Key Dates

Start Date

September 29, 2020

Primary Completion Date

September 12, 2022

Completion Date

December 2, 2022

Last Updated

November 13, 2023

Enrollment

763

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Ensifentrine

DRUG

Placebo

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

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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: November 13, 2023Data 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 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

Inclusion Criteria

Exclusion Criteria

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