Trial · NCT07132983
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
NCT07132983, 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. A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease. Trials, record NCT07132983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07132983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT07132983
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 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 42.5 mcg, Ensifentrine 1.5 mg, Ensifentrine 3 mg (marketed formulation)
- First posted
- 2025-08-20
- Last updated
- 2026-01-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ensifentrine single dose area under the curve from time 0 to time t (AUC0-t) | Day 1 through 48 hours after each dose of study medication | |
| Primary | Ensifentrine single dose area under the curve from time 0 extrapolated to infinity (AUC0-inf) | Day 1 through 48 hours after each dose of study medication | |
| Primary | Ensifentrine single dose maximum observed concentration (Cmax) | Day 1 through 48 hours after each dose of study medication | |
| Primary | Glycopyrronium single dose AUC0-t | Day 1 through 48 hours after each dose of study medication | |
| Primary | Glycopyrronium single dose AUC0-inf | Day 1 through 48 hours after each dose of study medication | |
| Primary | Glycopyrronium single dose Cmax | Day 1 through 48 hours after each dose of study medication | |
| Primary | Change from average baseline in forced expiratory volume over 1 second (FEV1) to FEV1 area under the curve versus time from time 0 to 12 hours (AUC0-12h) | Baseline through 12 hours after each dose of study medication | |
| Primary | Change from average baseline FEV1 to average FEV1 area under the curve versus time from time 0 to 4 hours (AUC0-4h) | Baseline through 4 hours after each dose of study medication | |
| Primary | Change from average baseline FEV1 to peak FEV1 measured over 4 hours post-dose | Baseline through 4 hours after each dose of study medication | |
| Primary | Change from average baseline FEV1 to 12-hour post-dose (evening trough) FEV1 | Baseline through 12 hours after each dose of study medication |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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/NCT07132983
GET https://conductscience.org/api/trials/v1/NCT07132983/registered