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Summary
This trial tests a new drug, ensifentrine, to see if it's effective in treating asthma. Patients will receive the drug and a placebo at different times during the study, and researchers will compare the results.
Who is the study for?
This trial is for COPD patients aged 40-80 who have a history of smoking and moderate to severe lung function impairment. They must be using regular bronchodilator therapy, able to use a nebulizer correctly, and produce sputum samples. Exclusions include significant liver enzyme elevations, recent cancer (except certain skin cancers), immunodeficiency, recent experimental drug/device use or other serious health issues.
What is being tested?
The study tests the effect of ensifentrine versus placebo on inflammation in COPD patients. It's a double-blind study where participants receive both treatments across two periods totaling up to 24 weeks with seven clinic visits. Ensifentrine is administered twice daily via nebulization.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to inhaling medication such as throat irritation or coughing, and systemic effects like headaches or gastrointestinal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent change from baseline in sputum Acetylated Proline-Glycine-Proline (AcPGP) at Week 8.
Secondary study objectives
Change from baseline in other sputum PMN counts (eosinophils, basophils, macrophages, lymphocytes, total cells) at Week 8 (absolute change in cell numbers).
Change from baseline in sputum neutrophils at Week 8 (absolute change in cell numbers).
Percent change from baseline in sputum PMN counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes and total cells) at Week 8.
+4 moreOther study objectives
Exploratory: change from baseline in absolute PMN in blood after 4 weeks.
Exploratory: change from baseline in absolute PMN in blood after 8 weeks.
Exploratory: change from baseline in inflammatory markers in blood after 4 weeks.
+1 moreSide effects data
From 2022 Phase 3 trial • 763 Patients • NCT045359863%
Nasopharyngitis
2%
Upper respiratory tract infection
2%
Headache
1%
COVID-19
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Up to Week 24: Placebo
From Week 24 to Week 48: Ensifentrine
Up to Week 24: Ensifentrine
From Week 24 to Week 48: Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Sequence 2Experimental Treatment2 Interventions
Treatment Period 1 (blinded Placebo) followed by Treatment Period 2 (blinded Ensifentrine)
Group II: Treatment Sequence 1Experimental Treatment2 Interventions
Treatment Period 1 (blinded Ensifentrine) followed by Treatment Period 2 (blinded Placebo)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensifentrine
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamOTHER
1,646 Previous Clinical Trials
2,342,723 Total Patients Enrolled
Verona Pharma plcLead Sponsor
15 Previous Clinical Trials
2,987 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 40 and 80 years old, have smoked at least 10 packs of cigarettes in your life, and have been diagnosed with COPD based on specific guidelines.You can use the jet nebulizer correctly and follow all study rules. You can do spirometry tests as instructed and provide sputum samples when needed.You have been diagnosed with a lung disease other than COPD, like asthma or cystic fibrosis. You have been hospitalized for COPD, pneumonia, or COVID-19 in the past 12 weeks, or you currently have an active COVID-19 infection. However, if you had a positive COVID-19 antibody test in the past and do not have any symptoms of an active infection, you can still participate in the study. If you had a positive COVID-19 test less than 30 days ago, you may be able to participate after waiting for 30 days or as per local requirements.You have abnormal heart rhythm or a history of heart problems. You are not suitable for the study if you have had bad reactions to certain medications or if you cannot use the study-supplied medication for COPD as directed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Sequence 2
- Group 2: Treatment Sequence 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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