Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD
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Official title
A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Ranging Study to Assess the Effect of RPL554 Added on to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to investigate the dose response of RPL554 in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite treatment with a stable background of tiotropium over 4 weeks of treatment. This study is intended to support optimal dose selection for a Phase III program evaluating RPL554 as an add-on treatment to standard of care therapy.
Study identification
- NCT ID
- NCT03937479
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Industry
- Enrollment
- 416 participants
Conditions and interventions
Conditions
Interventions
- Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium Drug
- Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium Drug
- Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium Drug
- Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium Drug
- Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2019 (Actual)
- Primary completion
- Nov 15, 2019 (Actual)
- Completion
- Nov 15, 2019 (Actual)
- Last update posted
- Nov 20, 2020
2019
United States locations
- U.S. sites
- 50
- U.S. states
- 14
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| California Research Medical Group, Inc | Fullerton | California | 92835 | — |
| Southern California Institute For Respiratory Diseases, Inc. | Los Angeles | California | 90048 | — |
| Innovative Clinical Research | Lafayette | Colorado | 80026 | — |
| Meris Clinical Research | Brandon | Florida | 33511 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Pulmonary Disease Specialists, PA d/b/a PDS Research | Kissimmee | Florida | 34741 | — |
| Medical Research of Central Florida, LLC | Leesburg | Florida | 34748 | — |
| Clinical Trials of Florida, LLC | Miami | Florida | 33186 | — |
| Peninsula Research, Ormond Beach, LLC | Ormond Beach | Florida | 32174 | — |
| Medsol Clinical Research Center, Inc | Port Charlotte | Florida | 33952 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Pasadena Center for Medical Research, LLC | St. Petersburg | Florida | 33707 | — |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| VitaLink Research - Hamilton Mill | Dacula | Georgia | 30019 | — |
| VitaLink Research - Duluth | Duluth | Georgia | 30096 | — |
| Gwinnett Biomedical Research | Lawrenceville | Georgia | 30046 | — |
| IACT Health | Rincon | Georgia | 31326 | — |
| Vitalink | Winder | Georgia | 30680 | — |
| Genesis Clinical Research and Consulting, LLC | Fall River | Massachusetts | 02723 | — |
| Pulmonary Research Institute of Southeast Michigan | Farmington Hills | Michigan | 48336 | — |
| Cities Research Center | Fridley | Minnesota | 34741 | — |
| American Health Research | Charlotte | North Carolina | 28078 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Research Carolina of Huntersville | Huntersville | North Carolina | 28078 | — |
| Clinical Research of Lake Norman | Mooresville | North Carolina | 28117 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Aventiv Research, Inc | Columbus | Ohio | 43213 | — |
| Aventiv Research, Inc | Dublin | Ohio | 43016 | — |
| Crisor, LLC | Medford | Oregon | 97504 | — |
| Vitalink Research - Anderson | Anderson | South Carolina | 29621 | — |
| Lowcountry Lung and Critical Care, PA | Charleston | South Carolina | 29406 | — |
| VitaLink-Columbia | Columbia | South Carolina | 33765 | — |
| VitaLink Research - Easley | Easley | South Carolina | 29640 | — |
| Piedmont Research Partners, LLC | Fort Mill | South Carolina | 29707 | — |
| VitaLink Research-Gaffney | Gaffney | South Carolina | 29340 | — |
| VitaLink Research-Greenville | Greenville | South Carolina | 29615 | — |
| VitaLink Research-UPSTATE | Greenville | South Carolina | 29615 | — |
| Clinical Research of Charleston | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | — |
| Vitalink Research-Seneca | Seneca | South Carolina | 29678 | — |
| Fusion Clinical Research of Spartanburg, LLC | Spartanburg | South Carolina | 29301 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29301 | — |
| Vitalink Research-Spartanburg | Spartanburg | South Carolina | 29303 | — |
| VitaLink Research - Union | Union | South Carolina | 29379 | — |
| New Phase Research & Development | Knoxville | Tennessee | 37909 | — |
| FMC Science, LLC | Lampasas | Texas | 76550 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Metroplex Pulmonary and Sleep Center | McKinney | Texas | 75069 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03937479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2020 · Synced Nov 15, 2026
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