Ensifentrine for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Obstructive Pulmonary Disease (COPD)Ensifentrine - Drug
Eligibility
40 - 80
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Week 8

Week 4
Exploratory: change from baseline in absolute PMN in blood after 4 weeks.
Exploratory: change from baseline in inflammatory markers in blood after 4 weeks.
Week 8
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).
Exploratory: change from baseline in absolute PMN in blood after 8 weeks.
Exploratory: change from baseline in inflammatory markers in blood after 8 weeks.
Percent change from baseline in sputum Acetylated Proline-Glycine-Proline (AcPGP) at Week 8.
Percent change from baseline in sputum PMN counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes and total cells) at Week 8.
Percent change from baseline in sputum Proline-Glycine-Proline (PGP) at Week 8.
Percent change from baseline in sputum cytokines, proteases, and other markers of inflammation at Week 8.
Safety: changes in lung function
Safety: incidence of AEs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

Treatment Sequence 2
1 of 2
Treatment Sequence 1
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Ensifentrine · Has Placebo Group · Phase 2

Treatment Sequence 2Experimental Group · 2 Interventions: Placebo, Ensifentrine · Intervention Types: Drug, Drug
Treatment Sequence 1Experimental Group · 2 Interventions: Placebo, Ensifentrine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Ensifentrine
2020
Completed Phase 3
~810

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 8

Who is running the clinical trial?

Verona Pharma plcLead Sponsor
12 Previous Clinical Trials
2,802 Total Patients Enrolled
7 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
2,584 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
University of Alabama at BirminghamOTHER
1,434 Previous Clinical Trials
2,229,172 Total Patients Enrolled
16 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
8,225 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age 40 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are capable of using the jet nebulizer correctly and complying with all study restrictions and procedures