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Bronchodilator

Ensifentrine for Chronic Obstructive Pulmonary Disease

Phase 3
Waitlist Available
Research Sponsored by Verona Pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Informed Consent
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (average of 7 days before first administration on day 1) and weeks 6, 12, and 24
Awards & highlights

Study Summary

This study is evaluating whether a drug called ensifentrine may help treat COPD.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (average of 7 days before first administration on day 1) and weeks 6, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (average of 7 days before first administration on day 1) and weeks 6, 12, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Least Square (LS) Mean Change From Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12
Secondary outcome measures
LS Mean Change From Baseline FEV1 to Evening Trough FEV1 at Week 12
LS Mean Change From Baseline FEV1 to Morning Trough FEV1 at Weeks 6, 12 and 24
LS Mean Change From Baseline FEV1 to Peak FEV1 at Day 1 and Weeks 6, 12 and 24
+6 more

Side effects data

From 2022 Phase 3 trial • 763 Patients • NCT04535986
3%
Nasopharyngitis
2%
Headache
2%
Upper respiratory tract infection
1%
COVID-19
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
From Week 24 to Week 48: Placebo
From Week 24 to Week 48: Ensifentrine
Up to Week 24: Ensifentrine
Up to Week 24: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
Ensifentrine Nebulized Suspension; 3 mg twice daily for 24 weeks
Group II: Arm 2Placebo Group1 Intervention
Ensifentrine Placebo Nebulized Solution; twice daily for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensifentrine
2023
Completed Phase 3
~1590

Find a Location

Who is running the clinical trial?

Verona Pharma plcLead Sponsor
12 Previous Clinical Trials
1,997 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,218 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
New York
How old are they?
65+
What site did they apply to?
Diagnostics Research Group
What portion of applicants met pre-screening criteria?
Met criteria
~176 spots leftby Mar 2025