Trial · NCT07016412
Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)
NCT07016412, Phase 2, Completed, Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212). Trials, record NCT07016412. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07016412
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)
- NCT number
- NCT07016412
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 497 participants, actual
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Ensifentrine 3 mg, Glycopyrrolate 21.25 mcg, Glycopyrrolate 42.5 mcg, Placebo
- First posted
- 2025-06-11
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Forced Expiry Volume in 1 Second (FEV1) Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours on Day 28 will be reported. |
| Secondary | Change From Baseline in Peak FEV1 Measured Over 4 Hours Post-Dose | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following dosing on Day 28 will be reported. |
| Secondary | Change From Baseline in Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h) | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 12 hours on Day 28 will be reported. |
| Secondary | Change From Baseline in Morning Trough FEV1 on Day 29 | Baseline and Day 29 | Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 29 will be reported. |
| Secondary | Change From Baseline in Evening Trough FEV1 on Day 28 | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in evening trough FEV1 measured on Day 28 will be reported. |
| Secondary | Change From Baseline in Morning Trough FEV1 on Day 28 | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 28 will be reported. |
| Secondary | Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 14 | Baseline and Day 14 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 14 will be reported. |
| Secondary | Change From Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 14 | Baseline and Day 14 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 14 will be reported. |
| Secondary | Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 1 | Baseline and Day 1 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 1 will be reported. |
| Secondary | Change from Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 1 | Baseline and Day 1 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 1 will be reported. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07016412
GET https://conductscience.org/api/trials/v1/NCT07016412/registered?page=2