Trials / Completed
CompletedNCT04542057
A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 790 (actual)
- Sponsor
- Verona Pharma plc · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ensifentrine | Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks |
| DRUG | Placebo | Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks |
Timeline
- Start date
- 2020-09-22
- Primary completion
- 2022-05-03
- Completion
- 2022-07-06
- First posted
- 2020-09-09
- Last updated
- 2023-10-16
- Results posted
- 2023-07-24
Locations
130 sites across 10 countries: United States, Belgium, Bulgaria, Canada, Denmark, Estonia, Hungary, Poland, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04542057. Inclusion in this directory is not an endorsement.