Trials / Completed
CompletedNCT04535986
A Phase 3 Clinical 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 (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 763 (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 evaluate the efficacy and safety of ensifentrine in 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 or 48 weeks |
| DRUG | Placebo | Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks |
Timeline
- Start date
- 2020-09-29
- Primary completion
- 2022-09-12
- Completion
- 2022-12-02
- First posted
- 2020-09-02
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
122 sites across 12 countries: United States, Bulgaria, Czechia, Germany, Greece, Hungary, Poland, Romania, Russia, Slovakia, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04535986. Inclusion in this directory is not an endorsement.