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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-dose on day 1), post-dose on day 1, weeks 6, 12, and 24
Awards & highlights

Study Summary

This trial will test if a new drug called ensifentrine is safe and helpful for people with moderate to severe COPD.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose on day 1), post-dose on day 1, weeks 6, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose on day 1), post-dose on day 1, 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%
Upper respiratory tract infection
2%
Headache
1%
Chronic obstructive pulmonary disease
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
From Week 24 to Week 48: Ensifentrine
Up to Week 24: Placebo
Up to Week 24: Ensifentrine
From Week 24 to Week 48: Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1Experimental Treatment1 Intervention
Ensifentrine Nebulized Suspension; 3 mg BID
Group II: Arm 2Placebo Group1 Intervention
Placebo Nebulized BID
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
2,024 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
106 Previous Clinical Trials
169,245 Total Patients Enrolled

Frequently Asked Questions

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

How many staff members are needed to manage this research project?

"Presently, the study is being conducted in 36 different centres, which are situated in Abingdon, Monroe, Miami and other cities. If you wish to take part in this research project, it would be advantageous to choose a location close to your home to minimize travel requirements."

Answered by AI

Has this type of trial been conducted before?

"Ensifentrine's clinical trials started in 2020. The first study, sponsored by Iqvia Pty Ltd., was completed that year with a sample size of 800. After Phase 3 drug approval, the only active Ensifentrine study today is once again being sponsored by Iqvia Pty Ltd."

Answered by AI

Does this research project have an age limit?

"People who meet the age requirements of 40 to 80 years old are able to apply for this clinical trial. In contrast, there are 15 trials available for minors and 346 trials open to senior citizens."

Answered by AI

How large is the sample size for this experiment?

"Currently, this research study is not recruiting patients. The trial was created on September 29th, 2020 and edited last on October 31st, 2022. There are other studies you can explore; as of now, there are 1 trials for Ensifentrine actively searching for patients and 351 studies actively enrolling patients with chronic obstructive airway disease."

Answered by AI

Are there any other scientific papers that mention Ensifentrine?

"Ensifentrine was first trialled in 2020 at the Korea University Anam Hospital. Since then, 18295 more clinical trials have completed. As of now, there is 1 active clinical trial recruiting patients. This particular trial is based out of Abingdon, Virginia."

Answered by AI

Is it legal to market and distribute Ensifentrine in the United States?

"There is prior clinical data supporting Ensifentrine's safety, so it received a score of 3."

Answered by AI

Are new participants being allowed to join this clinical trial at this time?

"Although not currently recruiting patients, this study was first posted on September 29th 2020. The trial has since been updated on October 31st of this year. There are 352 other trials that are actively searching for participants which you can view here."

Answered by AI

If I wanted to, could I join this clinical trial?

"This study is recruiting 800 patients with chronic obstructive airway disease aged 40 and 80. Most notable, candidates are required to meet the following criteria: -Smoking History: Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years at Screening (Visit 0) [number of pack years = (number of cigarettes per day / 20) × number of years smoked (eg, 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"

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
IMA Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Most responsive sites:
  1. IMA Clinical Research, LLC: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~170 spots leftby Apr 2025