Phase 3
N=20
Effect of Ensifentrine Treatment on CAT Score
COPD
Bottom Line
View on ClinicalTrials.gov: NCT06460493 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ensifentrine 3 mg twice daily (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of CAT Score Responders in the Full Analysis Set at Week 12 |
12 | — |
| SECONDARY The Proportion of CAT Score Responders in the Full Analysis Set at Week 6 |
8 | — |
| SECONDARY Mean Change From Baseline - CAT Score in the Full Analysis Set |
-1.5; -2.3 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set |
-0.2; -0.3 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis Set |
0.0; -0.5 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis Set |
-0.3; -0.4 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis Set |
-0.9; -0.5 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis Set |
-0.2; -0.3 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (6, Confidence) in the Full Analysis Set |
0.1; -0.2 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (7, Sleep) in the Full Analysis Set |
0.0; 0.2 | — |
| SECONDARY Mean Change From Baseline - CAT Individual Item (8, Energy) in the Full Analysis Set |
0.0; -0.2 | — |
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. Subjects will continue the maintenance treatment during study participation.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT06460493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.