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NCT04535986 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Verona Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 763
- Enrollment target
- 20
- Study locations
NCT04535986: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Verona Pharma.
NCT04535986 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by Verona Pharma. The registered enrollment target is 763 participants, below the 1,745-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535986, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Verona Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 763 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ensifentrine
Study Locations (20)
Florida
- Clinical Research of West Florida, Inc. - Clearwater
- St. Francis Medical Institute - Clearwater
- Qway Research, LLC - Hialeah
- Multi-Specialty Research Associates, Inc. - Lake City
- Elite Clinical Research - Miami
- Global Research Solutions Corp - Miami
- Phoenix Medical Research - Miami
- Florida Institute for Clinical Research - Orlando
- Precision Clinical Research - Sunrise
- Clinical Research of West Florida, Inc. - Tampa
Georgia
- iResearch Atlanta, LLC - Decatur
- IACT Health - Rincon
- In-Quest Medical Research, LLC - Suwanee
Arizona
- Phoenix Medical Group - Peoria
- AMR Tempe - Tempe
California
- Beach Physicians Medical Group - Huntington Beach
- Downtown LA Research Center, Inc. - Los Angeles
Maryland
- John Hopkins University School of Medicine - Baltimore
Michigan
- Pulmonary Research Institute of SE Michigan - Farmington Hills
Missouri
- Midwest Chest Consultants - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 763 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2022-12-02 |
| Phase | Phase 3 |
What the finished NCT04535986 record still lists
NCT04535986 is an interventional study that assigns participants to a tested intervention. The registered 763 participants enrollment target is mid-sized for trials with a published cap, below the 1,745-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04535986 names 20 study sites across 7 states, led by Florida, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT04535986 about?
NCT04535986 is a clinical study titled "A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD". 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).
What is the current status of trial NCT04535986?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 763 participants. The study started on 2020-09-29. Estimated completion is 2022-12-02.
What conditions does trial NCT04535986 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT04535986?
The interventions under investigation include: Placebo (DRUG), Ensifentrine (DRUG).
Who is sponsoring clinical trial NCT04535986?
This trial is sponsored by Verona Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04535986 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04535986's enrollment target sits among peer trials
763 18th of 86 higher than 69 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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