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Bronchodilator

Ensifentrine for COPD

Phase 3
Recruiting
Research Sponsored by Verona Pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established clinical history of moderate to severe COPD
Capable of giving informed consent
Must not have
Lower respiratory tract infection within the past 6 weeks or an active infection
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 [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

"This trial will test how a new medication called ensifentrine, taken through a nebulizer twice a day, affects the symptoms of COPD in patients over a 12-week period. Patients

Who is the study for?
This trial is for adults with moderate to severe COPD who are current or former smokers with a significant smoking history. They must have specific lung function scores, experience breathlessness, and be on stable COPD medication. Participants need to be able to use a nebulizer and perform breathing tests.
What is being tested?
The study is testing the effects of Ensifentrine 3mg when inhaled twice daily over 12 weeks on COPD symptoms. It's an open-label trial where everyone knows they're getting Ensifentrine while continuing their usual COPD treatments.
What are the potential side effects?
While not explicitly listed here, common side effects of similar respiratory treatments may include coughing, dry mouth, headache, throat irritation, and potentially worsening breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of moderate to severe COPD.
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I understand the details of the clinical trial and can agree to participate.
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I have smoked at least 10 pack-years.
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My lung function after using albuterol is between 30% and 75% of the expected normal.
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I often feel out of breath when moving around.
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My COPD score is 10 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a lung infection or any active infection in the last 6 weeks.
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I have a lung condition other than COPD that affects my health significantly.
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I have HIV or another condition that weakens my immune system.
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I had lung surgery less than a year ago.
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I use oxygen therapy for more than 12 hours daily.
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I have had severe COPD requiring ICU stay or intubation in the last year.
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I have not fully recovered from a major surgery in the last 6 weeks or have surgery planned.
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I have been diagnosed with severe chronic kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change from baseline in CAT score
Change from baseline in individual item CAT score
The proportion of CAT score responders

Trial Design

1Treatment groups
Experimental Treatment
Group I: EnsifentrineExperimental Treatment1 Intervention
Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer.

Find a Location

Who is running the clinical trial?

Verona Pharma plcLead Sponsor
15 Previous Clinical Trials
3,017 Total Patients Enrolled
Midwest Chest ConsultantsUNKNOWN
1 Previous Clinical Trials
32 Total Patients Enrolled
~0 spots leftby Oct 2024
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