Chronic Obstructive Pulmonary DiseasePhase 2NCT06545500
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
A Phase 2 study testing Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg) and Glycopyrrolate (14 μg) in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 7 sites in United States.
Trial summary
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg) and Glycopyrrolate (14 μg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Aug 2024to 8 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males are eligible to participate if they agree to use contraception from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
- Females are eligible to participate if they are not pregnant, not breastfeeding, and ≥ 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
- Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening. Smoking cessation programs are permitted during the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD.
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- Post-bronchodilator (4 puffs of salbutamol) spirometry at Screening demonstrating both the following:
- FEV1/forced vital capacity (FVC) ratio of < 0.70 AND
- FEV1 ≥ 30 % and ≤ 70% of predicted normal
- A posterior-anterior chest x-ray (CXR) at Screening or within 12 months prior to Screening showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR.
- Capable of withdrawing from short-acting bronchodilators for 4 hours prior to spirometry testing and from BID LABA ± ICS therapy for 24 hours prior to spirometry.
- Capable of using the study nebulizer correctly.
- Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines
- Willing and able to attend all study visits and adhere to all study assessments and procedures.
Who cannot join
- Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease).
- Within 6 months prior to Screening:
- COPD exacerbation requiring hospitalization.
- Use of therapies for COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids).
- Lower respiratory tract infection within 6 weeks of Screening or an active infection at Screening.
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation.
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- Previous lung resection or lung reduction surgery within 1-year of Screening.
- Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤ 12 hours per day) is not exclusionary.
- Severe comorbidities including unstable cardiac, or any other clinically significant medical conditions including uncontrolled diseases that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
- History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
- History of narrow angle glaucoma.
- History of hypersensitivity or intolerance to aerosol medications, salbutamol or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines.
- Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to Screening (Visit 1) and remains stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study.
- Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
- History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.
- Current or history of drug or alcohol abuse within the past 5 years.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min.
- Women who are breast feeding.
- Use of an experimental drug within 30 days or within 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to Screening.
- Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to Screening.
- Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
American Health Research Inc
Charlotte, North Carolina, 28277
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615
Midwest Chest Consultants PC
Saint Charles, Missouri, 63301
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, 33606
Velocity Clinical Research - Union
Union, South Carolina, 29379
About this study
Official title: A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).
Read the detailed description
Participants enrolled will be expected to participate for approximately 10 weeks;1-2 weeks for screening, four 1-week treatment periods separated by 1 week of washout between each treatment, and 1 week of follow-up. Participants will be randomized to a treatment sequence, 1-4, which will determine the order that they receive the dose levels during the four treatment periods of the study. Neither participants nor study staff will know which dose a participant is receiving in any given treatment period. All participants will receive all 4 dose levels and it is expected that each participant completes all four treatment periods in their assigned sequence. The primary objective of this study is to evaluate the bronchodilator effect of twice daily inhaled glycopyrrolate solution over a dose range administered by standard jet nebulizer in subjects with COPD on Day 7, to support the selection of the glycopyrrolate doses for further clinical development in a fixed-dose combination with ensifentrine.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg), Glycopyrrolate (14 μg), Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrrolate (85 μg)Drug
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Glycopyrrolate (42.5 μg)Drug
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Glycopyrrolate (14 μg)Drug
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
PlaceboDrug
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Dose Level A | Experimental | The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Receives: Drug: Glycopyrrolate (85 μg) |
| Dose Level B | Experimental | The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Receives: Drug: Glycopyrrolate (42.5 μg) |
| Dose Level C | Experimental | The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Receives: Drug: Glycopyrrolate (14 μg) |
| Dose Level D | Placebo comparator | The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Measured: Baseline (pre-dose for each treatment period) and Day 7
Secondary outcomes (10)
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours
Measured: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)
The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Measured: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)
The endpoint is measured as AUC/12 hour time interval resulting in an average volume measure in liters.
Measured: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Evening Trough FEV1
Measured: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose
Measured: Baseline (pre-dose) and Day 1
Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose
The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Measured: Baseline (pre-dose) and Day 1
Number of Treatment Emergent Adverse Events (TEAEs)
Measured: From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total.
Glycopyrronium Free Base AUC0-12h
Measured: After morning dose Day 7
Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax)
Measured: After morning dose Day 7
Glycopyrronium Free Base Time to Maximum Plasma Drug Concentration (Tmax)
Measured: After morning dose Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Aug 2024
- Primary completion2 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant is expected to complete all 4 treatment periods, each consisting of a different dose level of blinded medication depending on the treatment sequence they were assigned to
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545500
- Sponsor's protocol ID
- RPL554-CO-211
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2024
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
- ClinicalTrials.gov ID
- NCT06545500
- Acronym / sponsor ID
- RPL554-CO-211
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).
Detailed description
Participants enrolled will be expected to participate for approximately 10 weeks;1-2 weeks for screening, four 1-week treatment periods separated by 1 week of washout between each treatment, and 1 week of follow-up. Participants will be randomized to a treatment sequence, 1-4, which will determine the order that they receive the dose levels during the four treatment periods of the study. Neither participants nor study staff will know which dose a participant is receiving in any given treatment period. All participants will receive all 4 dose levels and it is expected that each participant completes all four treatment periods in their assigned sequence. The primary objective of this study is to evaluate the bronchodilator effect of twice daily inhaled glycopyrrolate solution over a dose range administered by standard jet nebulizer in subjects with COPD on Day 7, to support the selection of the glycopyrrolate doses for further clinical development in a fixed-dose combination with ensifentrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Each participant is expected to complete all 4 treatment periods, each consisting of a different dose level of blinded medication depending on the treatment sequence they were assigned to
| Arm | Type | Receives |
|---|---|---|
| Dose Level A | Experimental | Drug: Glycopyrrolate (85 μg)The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to |
| Dose Level B | Experimental | Drug: Glycopyrrolate (42.5 μg)The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to |
| Dose Level C | Experimental | Drug: Glycopyrrolate (14 μg)The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to |
| Dose Level D | Placebo comparator | Drug: PlaceboThe treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males are eligible to participate if they agree to use contraception from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
- Females are eligible to participate if they are not pregnant, not breastfeeding, and ≥ 1 of the following conditions apply:
- Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening. Smoking cessation programs are permitted during the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD.
- Post-bronchodilator (4 puffs of salbutamol) spirometry at Screening demonstrating both the following:
Key exclusion criteria (21 listed)
- Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease).
- Within 6 months prior to Screening:
- Lower respiratory tract infection within 6 weeks of Screening or an active infection at Screening.
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation.
- Previous lung resection or lung reduction surgery within 1-year of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycopyrrolate (85 μg)Administered by a standard jet nebulizer, twice daily for 7 consecutive days | Drug | Dose Level A |
| Glycopyrrolate (42.5 μg)Administered by a standard jet nebulizer, twice daily for 7 consecutive days | Drug | Dose Level B |
| Glycopyrrolate (14 μg)Administered by a standard jet nebulizer, twice daily for 7 consecutive days | Drug | Dose Level C |
| PlaceboAdministered by a standard jet nebulizer, twice daily for 7 consecutive days | Drug | Dose Level D |
Primary outcome
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (pre-dose for each treatment period) and Day 7
10 secondary outcomes
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Evening Trough FEV1
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose
Time frame: Baseline (pre-dose) and Day 1
Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose
Time frame: Baseline (pre-dose) and Day 1
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total.
Glycopyrronium Free Base AUC0-12h
Time frame: After morning dose Day 7
Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax)
Time frame: After morning dose Day 7
Glycopyrronium Free Base Time to Maximum Plasma Drug Concentration (Tmax)
Time frame: After morning dose Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glycopyrrolate (85 μg), Glycopyrrolate (42.5 μg) and Glycopyrrolate (14 μg) in people with Chronic Obstructive Pulmonary Disease, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline (pre-dose for each treatment period) and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.