| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06460493 | Effect of Ensifentrine Treatment on CAT Score | PHASE3 | COMPLETED | 20 | — | — | Jun 11, 2024 | Dec 3, 2024 | Apr 18, 2025 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Ensifentrine 3 mg twice daily | DRUG | All subjects will receive ensifentrine. |
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 \< 0.70. * Post-albuterol FEV1 ≥ 30 % and ≤ 75%...