COPDPhase 3NCT06460493
Effect of Ensifentrine Treatment on CAT Score
A Phase 3 study testing Ensifentrine 3 mg twice daily in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 1 site in United States.
Trial summary
The purpose of this open-label, single center trial is to assess the effect of twice daily nebulized ensifentrine (3 mg) on COPD symptoms measured by the COPD Assessment Test (CAT™) scores over 12 weeks in subjects with symptomatic, moderate to severe COPD, taking maintenance LAMA/LABA or LAMA/LABA/ICS therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Ensifentrine 3 mg twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 3 Dec 2024
- Phase
- Phase 3
- 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
- Capable of giving informed consent.
- Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years.
- Established clinical history of moderate to severe COPD.
- Pre- and post-albuterol FEV1/FVC ratio of < 0.70.
- Post-albuterol FEV1 ≥ 30 % and ≤ 75% of predicted normal.
- ≥2 on the modified Medical Research Council (mMRC) Dyspnea Scale.
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- ≥10 on the COPD Assessment Test™.
- Taking stable dual (LAMA+LABA) or triple (LAMA+LABA+ICS) maintenance therapy for at least 8 weeks.
- Capable of using a standard jet nebulizer and performed spirometry assessment.
Who cannot join
- Hospitalizations for COPD (or COPD exacerbation), pneumonia, or other serious infection or treatment with oral or parenteral (oral, intravenous, or intramuscular) glucocorticoids within the past 12 weeks.
- Lower respiratory tract infection within the past 6 weeks or an active infection.
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation within 1-year.
- Major surgery (requiring general anesthesia) within the past 6 weeks, lack of full recovery from surgery, or planned surgery through the end of the study.
- Concomitant clinically significant pulmonary disease other than COPD (e.g., 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).
- Severe comorbidities including unstable cardiac, (e.g., myocardial infarction within 1 year prior to screening, unstable angina within 6 months, or unstable or life-threatening arrhythmia requiring intervention within 3 months) or any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric or ophthalmic 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.
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- HIV infection or other immunodeficiency.
- Previous lung resection or lung reduction surgery within 1-year.
- Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day.
- Pulmonary rehabilitation unless such treatment has been stable for at least 4 weeks and remains stable during 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.
- Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
- Findings on physical examination that an investigator considers to be clinically significant.
- Known alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if fractionated bilirubin < 35%).
- Known diagnosis of severe chronic kidney disease.
- Any other known abnormal clinical, cardiac or laboratory (hematology, biochemistry or viral) findings, deemed by an investigator to be clinically significantly abnormal.
- Use of prohibited medications, including nebulized medication, within the time intervals.
- Current or history of drug or alcohol abuse within the past 5 years.
- Women who are breast feeding.
- Use of an experimental drug within 30 days or 5 half-lives, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days.
- Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days.
- 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.
- A disclosed history or one known to the Investigator of significant noncompliance in previous investigational studies or with prescribed medications.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Chest Consultants
Saint Charles, Missouri, 63301
About this study
Official title: A Study Assessing the Effect of Ensifentrine on CAT™ Scores Over 12 Weeks in Subjects With Moderate to Severe COPD
The purpose of this open-label, single center trial is to assess the effect of twice daily nebulized ensifentrine (3 mg) on COPD symptoms measured by the COPD Assessment Test (CAT™) scores over 12 weeks in subjects with symptomatic, moderate to severe COPD, taking maintenance LAMA/LABA or LAMA/LABA/ICS therapy. Subjects will continue the maintenance treatment during study participation.
- Conditions
- COPD
- Being tested
- Ensifentrine 3 mg twice daily
- 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.
Ensifentrine 3 mg twice dailyDrug
Also called RPL554
All subjects will receive ensifentrine.
| Study group | Role | What they receive |
|---|---|---|
| Ensifentrine | Experimental | Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy. Receives: Drug: Ensifentrine 3 mg twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of CAT Score Responders in the Full Analysis Set at Week 12
Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.
Measured: 12 Weeks
Secondary outcomes (10)
The Proportion of CAT Score Responders in the Full Analysis Set at Week 6
Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.
Measured: 6 Weeks
Mean Change From Baseline - CAT Score in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12. A decrease from baseline indicates an improvement in COPD symptoms.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 1: (0) I never cough → (5) I cough all the time. CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 2: (0) I have no phlegm (mucus) in my chest at all → (5) My chest is completely full of phlegm (mucus) CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 3: (0) My chest does not feel tight at all → (5) My chest feels very tight CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 4: (0) When I walk up a hill or one flight of stairs I am not breathless → (5) When I walk up a hill or one flight of stairs I am very breathless CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 5: (0) I am not limited doing any activities at home → (5) I am very limited doing activities at home CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (6, Confidence) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 6: (0) I am confident leaving my home despite my lung condition → (5) I am not at all confident leaving my home because of my lung condition CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (7, Sleep) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 7: (0) I sleep soundly → (5) I don't sleep soundly because of my lung condition CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (8, Energy) in the Full Analysis Set
The COPD Assessment Test (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact.
Question 8: (0) I have lots of energy → (5) I have no energy at all CAT was self-completed at baseline, week 6 and week 12.
Measured: At week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start11 Jun 2024
- Primary completion26 Nov 2024
- Study completion3 Dec 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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)
- Collaborators
- Midwest Chest Consultants
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460493
- Sponsor's protocol ID
- RPL554-CO-303
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers.
Publications
Siler TM, Rheault T, Reyner D, MacDonald-Berko M, Davidson J, Rickard K. Ensifentrine Added on to Dual Bronchodilator or Triple Therapy Demonstrates Clinically Meaningful Improvement in CAT Score in Symptomatic Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2026 Feb 10;21:589655. doi: 10.2147/COPD.S589655. eCollection 2026.
PubMed 41710324
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Effect of Ensifentrine on CAT™ Scores Over 12 Weeks in Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT06460493
- Acronym / sponsor ID
- RPL554-CO-303
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USAIndustry (pharma, biotech, devices)
- Collaborators
- Midwest Chest Consultants
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label, single center trial is to assess the effect of twice daily nebulized ensifentrine (3 mg) on COPD symptoms measured by the COPD Assessment Test (CAT™) scores over 12 weeks in subjects with symptomatic, moderate to severe COPD, taking maintenance LAMA/LABA or LAMA/LABA/ICS therapy. Subjects will continue the maintenance treatment during study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensifentrine | Experimental | Drug: Ensifentrine 3 mg twice dailyInhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving informed consent.
- Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years.
- Established clinical history of moderate to severe COPD.
- Pre- and post-albuterol FEV1/FVC ratio of < 0.70.
- Post-albuterol FEV1 ≥ 30 % and ≤ 75% of predicted normal.
Key exclusion criteria (24 listed)
- Hospitalizations for COPD (or COPD exacerbation), pneumonia, or other serious infection or treatment with oral or parenteral (oral, intravenous, or intramuscular) glucocorticoids within the past 12 weeks.
- Lower respiratory tract infection within the past 6 weeks or an active infection.
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation within 1-year.
- Major surgery (requiring general anesthesia) within the past 6 weeks, lack of full recovery from surgery, or planned surgery through the end of the study.
- Concomitant clinically significant pulmonary disease other than COPD (e.g., 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).
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 |
|---|---|---|
| Ensifentrine 3 mg twice dailyAlso: RPL554All subjects will receive ensifentrine. | Drug | Ensifentrine |
Primary outcome
The Proportion of CAT Score Responders in the Full Analysis Set at Week 12
Time frame: 12 Weeks
Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.
10 secondary outcomes
The Proportion of CAT Score Responders in the Full Analysis Set at Week 6
Time frame: 6 Weeks
Mean Change From Baseline - CAT Score in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (6, Confidence) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (7, Sleep) in the Full Analysis Set
Time frame: At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (8, Energy) in the Full Analysis Set
Time frame: At week 6 and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41710324Siler TM, Rheault T, Reyner D, MacDonald-Berko M, Davidson J, Rickard K. Ensifentrine Added on to Dual Bronchodilator or Triple Therapy Demonstrates Clinically Meaningful Improvement in CAT Score in Symptomatic Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2026 Feb 10;21:589655. doi: 10.2147/COPD.S589655. eCollection 2026.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ensifentrine 3 mg twice daily in people with COPD, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 1 site 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 9 inclusion and 24 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Apr 2025). 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?
The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460493, which also lists 1 linked publication.
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 18 Apr 2025.