Trial · NCT06460493
Effect of Ensifentrine Treatment on CAT Score
NCT06460493, Phase 3, Completed, Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA; results first posted 2025-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Ensifentrine Treatment on CAT Score. Trials, record NCT06460493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06460493
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Ensifentrine Treatment on CAT Score
- NCT number
- NCT06460493
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Conditions
- COPD
- Interventions
- Ensifentrine 3 mg twice daily
- First posted
- 2024-06-14
- Last updated
- 2025-04-18
- Results first posted
- 2025-04-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 | 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. |
| Secondary | The Proportion of CAT Score Responders in the Full Analysis Set at Week 6 | 6 Weeks | 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. |
| Secondary | Mean Change From Baseline - CAT Score in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (6, Confidence) in the Full Analysis Set | At week 6 and week 12 | 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. |
| Secondary | Mean Change From Baseline - CAT Individual Item (7, Sleep) in the Full Analysis Set | At week 6 and week 12 | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 | 12 Weeks | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Proportion of CAT Score Responders in the Full Analysis Set at Week 6 | 6 Weeks | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline - CAT Score in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline in Blood Pressure in the Safety Analysis Set | 12 Weeks | The safety analysis set (SAS) included all subjects who were administered the study medication at day 1 (n=20). However, 2 subjects did not complete week 6 and week 12 visits and did not have a change from baseline calculated. | mmHg | MEAN |
| OTHER_PRE_SPECIFIED | Mean Change From Baseline in Pulse Rate in the Safety Analysis Set | 12 Weeks | The safety analysis set (SAS) included all subjects who were administered the study medication at day 1 (n=20). However, 2 subjects did not complete week 6 and week 12 visits and did not have a change from baseline calculated. | bpm | MEAN |
| SECONDARY | Mean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis Set | At week 6 and week 12 | The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 | Ensifentrine 3 mg BID | 12 | Participants | ||
| The Proportion of CAT Score Responders in the Full Analysis Set at Week 6 | Ensifentrine 3 mg BID | 8 | Participants | ||
| Mean Change From Baseline - CAT Score in the Full Analysis Set | Ensifentrine 3 mg BID | CAT score at week 6 (mean change from baseline) | -1.5 | 95% Confidence Interval -4.0 to 1.1 | units on a scale |
| Mean Change From Baseline - CAT Score in the Full Analysis Set | Ensifentrine 3 mg BID | CAT score at week 12 (mean change from baseline) | -2.3 | 95% Confidence Interval -4.0 to -0.6 | units on a scale |
| Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set | Ensifentrine 3 mg BID | CAT question 1 (cough) at week 6 (mean change from baseline) | -0.2 | 95% Confidence Interval -0.7 to 0.3 | units on a scale |
| Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set | Ensifentrine 3 mg BID | CAT question 1 (cough) at week 12 (mean change from baseline) | -0.3 | 95% Confidence Interval -0.9 to 0.4 | units on a scale |
| Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set | Ensifentrine 3 mg BID | CAT question 2 (mucus) at week 6 (mean change from baseline) | 0.0 | 95% Confidence Interval -0.7 to 0.6 | units on a scale |
| Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set | Ensifentrine 3 mg BID | CAT question 2 (mucus) at week 12 (mean change from baseline) | -0.5 | 95% Confidence Interval -1.1 to 0.0 | units on a scale |
| Mean Change From Baseline in Blood Pressure in the Safety Analysis Set | Ensifentrine 3 mg BID | Systolic blood pressure at week 12 (mean change from baseline) | 1.2 | Standard Deviation 15.08 | mmHg |
| Mean Change From Baseline in Blood Pressure in the Safety Analysis Set | Ensifentrine 3 mg BID | Diastolic blood pressure at week 12 (mean change from baseline) | 2.8 | Standard Deviation 10.37 | mmHg |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ensifentrine 3 mg BID | 20 | |
| Overall Study | COMPLETED | Ensifentrine 3 mg BID | 18 | |
| Overall Study | NOT COMPLETED | Ensifentrine 3 mg BID | 2 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ensifentrine 3 mg BID | 0 | 20 |
| Total, other adverse events | Ensifentrine 3 mg BID | 0 | 20 |
| Total, serious adverse events | Ensifentrine 3 mg BID | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41710324 | DERIVED |
Source PubMed
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.
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