Trial · NCT06545500
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
NCT06545500, Phase 2, Completed, Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA; results first posted 2026-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD. Trials, record NCT06545500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06545500
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
- NCT number
- NCT06545500
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg), Glycopyrrolate (14 μg), Placebo
- First posted
- 2024-08-09
- Last updated
- 2026-02-09
- Results first posted
- 2026-02-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Baseline (pre-dose for each treatment period) and Day 7 | |
| Secondary | Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Baseline (pre-dose for each treatment period) and Day 7 | |
| Secondary | Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Baseline (pre-dose for each treatment period) and Day 7 | The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters. |
| Secondary | Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h) | Baseline (pre-dose for each treatment period) and Day 7 | The endpoint is measured as AUC/12 hour time interval resulting in an average volume measure in liters. |
| Secondary | Change From Average Baseline FEV1 to Evening Trough FEV1 | Baseline (pre-dose for each treatment period) and Day 7 | |
| Secondary | Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose | Baseline (pre-dose) and Day 1 | |
| Secondary | Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose | Baseline (pre-dose) and Day 1 | The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters. |
| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total. | |
| Secondary | Glycopyrronium Free Base AUC0-12h | After morning dose Day 7 | |
| Secondary | Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax) | After morning dose Day 7 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Baseline (pre-dose for each treatment period) and Day 7 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Baseline (pre-dose for each treatment period) and Day 7 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Baseline (pre-dose for each treatment period) and Day 7 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h) | Baseline (pre-dose for each treatment period) and Day 7 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Evening Trough FEV1 | Baseline (pre-dose for each treatment period) and Day 7 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose | Baseline (pre-dose) and Day 1 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose | Baseline (pre-dose) and Day 1 | Liters | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Treatment Emergent Adverse Events (TEAEs) | From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total. | Events | NUMBER | |
| SECONDARY | Glycopyrronium Free Base AUC0-12h | After morning dose Day 7 | Placebo was excluded from the PK concentration listings. | h*pg/mL | MEAN |
| SECONDARY | Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax) | After morning dose Day 7 | Placebo was excluded from the PK concentration listings. | pg/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Dose Level A Glycopyrrolate (85 μg) | 0.0525 | Standard Error 0.02125 | Liters | |
| Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Dose Level B Glycopyrrolate (42.5 μg) | 0.0393 | Standard Error 0.02135 | Liters | |
| Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Dose Level C Glycopyrrolate (14 μg) | 0.0115 | Standard Error 0.02069 | Liters | |
| Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Dose Level D (Placebo) | -0.0287 | Standard Error 0.02029 | Liters | |
| Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Dose Level A Glycopyrrolate (85 μg) | 0.2333 | Standard Error 0.02304 | Liters | |
| Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Dose Level B Glycopyrrolate (42.5 μg) | 0.2042 | Standard Error 0.02314 | Liters | |
| Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Dose Level C Glycopyrrolate (14 μg) | 0.1568 | Standard Error 0.02243 | Liters | |
| Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours | Dose Level D (Placebo) | 0.0520 | Standard Error 0.02200 | Liters | |
| Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Dose Level A Glycopyrrolate (85 μg) | 0.0969 | Standard Error 0.02037 | Liters | |
| Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Dose Level B Glycopyrrolate (42.5 μg) | 0.0693 | Standard Error 0.02046 | Liters |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1 | 12 | |
| Overall Study | STARTED | Sequence 2 | 11 | |
| Overall Study | STARTED | Sequence 3 | 12 | |
| Overall Study | STARTED | Sequence 4 | 11 | |
| Overall Study | COMPLETED | Sequence 1 | 10 | |
| Overall Study | COMPLETED | Sequence 2 | 11 | |
| Overall Study | COMPLETED | Sequence 3 | 11 | |
| Overall Study | COMPLETED | Sequence 4 | 9 | |
| Overall Study | NOT COMPLETED | Sequence 1 | 2 | |
| Overall Study | NOT COMPLETED | Sequence 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Dose Level A Glycopyrrolate (85 μg) | 1 | 40 | |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Dose Level B Glycopyrrolate (42.5 μg) | 0 | 40 | |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Dose Level C Glycopyrrolate (14 μg) | 0 | 41 | |
| serious | CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Dose Level D (Placebo) | 0 | 43 | |
| serious | INJURY | Injury, poisoning and procedural complications | Dose Level A Glycopyrrolate (85 μg) | 0 | 40 | |
| serious | INJURY | Injury, poisoning and procedural complications | Dose Level B Glycopyrrolate (42.5 μg) | 1 | 40 | |
| serious | INJURY | Injury, poisoning and procedural complications | Dose Level C Glycopyrrolate (14 μg) | 0 | 41 | |
| serious | INJURY | Injury, poisoning and procedural complications | Dose Level D (Placebo) | 0 | 43 | |
| serious | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | Dose Level A Glycopyrrolate (85 μg) | 2 | 40 | |
| serious | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | Dose Level B Glycopyrrolate (42.5 μg) | 0 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level A Glycopyrrolate (85 μg) | 0 | 40 |
| Total, all-cause mortality | Dose Level B Glycopyrrolate (42.5 μg) | 0 | 40 |
| Total, all-cause mortality | Dose Level C Glycopyrrolate (14 μg) | 0 | 41 |
| Total, all-cause mortality | Dose Level D (Placebo) | 0 | 43 |
| Total, other adverse events | Dose Level A Glycopyrrolate (85 μg) | 0 | 40 |
| Total, other adverse events | Dose Level B Glycopyrrolate (42.5 μg) | 0 | 40 |
| Total, other adverse events | Dose Level C Glycopyrrolate (14 μg) | 0 | 41 |
| Total, other adverse events | Dose Level D (Placebo) | 0 | 43 |
| Total, serious adverse events | Dose Level A Glycopyrrolate (85 μg) | 2 | 40 |
| Total, serious adverse events | Dose Level B Glycopyrrolate (42.5 μg) | 1 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT06545500
GET https://conductscience.org/api/trials/v1/NCT06545500/results?page=2