A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Public ClinicalTrials.gov record NCT07016412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
Study identification
- NCT ID
- NCT07016412
- 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
- 497 participants
Conditions and interventions
Conditions
Interventions
- Ensifentrine 3 mg Drug
- Glycopyrrolate 21.25 mcg Drug
- Glycopyrrolate 42.5 mcg Drug
- Placebo 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
- Jul 30, 2025
- Primary completion
- Aug 16, 2026
- Completion
- Aug 16, 2026
- Last update posted
- Aug 27, 2026
2025 – 2026
United States locations
- U.S. sites
- 57
- U.S. states
- 19
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEC Clinical Research, LLC | Dothan | Alabama | 36305-7375 | — |
| Elite Clinical Studies, LLC | Phoenix | Arizona | 85018 | — |
| Tucson Clinical Research Institute | Tucson | Arizona | 85712 | — |
| Downtown LA Research Center Inc - ClinEdge | Los Angeles | California | 90017 | — |
| California Medical Research Associates, Inc. | Northridge | California | 91324-6200 | — |
| Northern California Research Corp | Sacramento | California | 95821-2640 | — |
| Clinical Research of West Florida Inc | Clearwater | Florida | 33765 | — |
| Fleming Island Center For Clinical Research | Fleming Island | Florida | 32003 | — |
| Florida Institute For Clinical Research LLC | Orlando | Florida | 32825-4454 | — |
| Ormond Beach Clinical Research | Ormond Beach | Florida | 32174-8196 | — |
| Progressive Medical Research | Port Orange | Florida | 32127-5169 | — |
| Clinical Research of West Florida Inc - Tampa | Tampa | Florida | 33606 | — |
| Centricity Research Columbus Georgia Multispecialty - PPDS | Columbus | Georgia | 31904 | — |
| ASHA Clinical Research - Hammond | Hammond | Indiana | 46324 | — |
| Velocity Clinical Research - Valparaiso | Valparaiso | Indiana | 46383 | — |
| Velocity Clinical Research (Rockville - Maryland) - PPDS | Rockville | Maryland | 20854-2960 | — |
| Revive Research Institute, Inc | Southfield | Michigan | 48075 | — |
| Clinical Research Institute, Inc - CRN | Plymouth | Minnesota | 55441-2676 | — |
| Midwest Chest Consultants PC | Saint Charles | Missouri | 63301 | — |
| Midwest Clinical Research LLC | St Louis | Missouri | 63141-7051 | — |
| The Clinical Research Center LLC - CRN | St Louis | Missouri | 63141 | — |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | — |
| Trialfinity Clinical Research Center | Hamilton | New Jersey | 08619 | — |
| Horizon Family Medical Group - New Windsor Primary Care | New Windsor | New York | 12553-7754 | — |
| American Health Research Inc | Charlotte | North Carolina | 28277 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054-7481 | — |
| Stern Research Partners, LLC | Huntersville | North Carolina | 28078 | — |
| Monroe Biomedical Research -343 Venus St | Monroe | North Carolina | 28112-4025 | — |
| Carolina Research Center, Inc | Shelby | North Carolina | 28150-3803 | — |
| Bernstein Clinical Research Center Inc | Cincinnati | Ohio | 45231-4927 | — |
| Remington Davis Clinical Research | Columbus | Ohio | 43215 | — |
| Advance Clinical Research | Kettering | Ohio | 45439 | — |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | 15801-2277 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Velocity Clinical Research - Anderson - PPDS | Anderson | South Carolina | 29621-4822 | — |
| Pharmacorp Clinical Trials Incorporated | Charleston | South Carolina | 29412 | — |
| Piedmont Research Partners LLC | Fort Mill | South Carolina | 29707-4514 | — |
| Velocity Clinical Research - Gaffney - PPDS | Gaffney | South Carolina | 29340-4737 | — |
| Lowcountry Lung and Critical Care PA | North Charleston | South Carolina | 29406 | — |
| Monroe Biomedical Research Charleston | North Charleston | South Carolina | 29406 | — |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303-4755 | — |
| Velocity Clinical Research | Spartanburg | South Carolina | 29303 | — |
| Velocity Clinical Research - Union - PPDS | Union | South Carolina | 29379 | — |
| Chattanooga Research & Medicine, PLLC | Chattanooga | Tennessee | 37404 | — |
| ClinSearch - Chattanooga | Chattanooga | Tennessee | 37421 | — |
| Clinical Trials Center of Middle Tennessee | Franklin | Tennessee | 37067-5665 | — |
| MultiSpecialty Clinical Research, Inc | Johnson City | Tennessee | 37604 | — |
| Inquest Clinical Research | Baytown | Texas | 77521 | — |
| Corsicana Medical Research | Corsicana | Texas | 75110-2471 | — |
| Horizon CR: Houston Pulmonary Sleep & Allergy Associates - Cypress - ClinEdge - PPDS | Cypress | Texas | 77429 | — |
| Greater Heights Memorial Pulmonary and Sleep | Houston | Texas | 77008 | — |
| Houston Pulmonary Medicine Associates, PA - Biopharma Informatic - PPDS | Houston | Texas | 77089 | — |
| Huntsville Research Institute LLC | Huntsville | Texas | 77340 | — |
| Element Research Group | San Antonio | Texas | 78258 | — |
| Sherman Clinical Research - 403 N. Highland Ave | Sherman | Texas | 75092 | — |
| Tranquil Clinical Research | Webster | Texas | 77598-4085 | — |
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 NCT07016412, 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 Aug 27, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07016412 live on ClinicalTrials.gov.