Effect of Ensifentrine Treatment on CAT Score
NCT Number: NCT06460493
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: COPD
Interventions: DRUG: Ensifentrine 3mg
Sponsor: Verona Pharma plc
Collaborators: Midwest Chest Consultants
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-11
Completion Date: 2024-11
Locations: Midwest Chest Consultants, Saint Charles, Missouri, 63301, United States

Summary:
This is an open-label study at one study center that will assess the effect of twice-daily nebulized ensifentrine on COPD Assessment Test (CAT™) scores over 12 weeks in subjects with moderate to severe COPD. Subjects will continue their long-acting dual or triple COPD maintenance treatments during study participation.

Primary Outcome Measures: The proportion of CAT score responders, Responders are defined as an improvement 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., 12 Weeks
Secondary Outcome Measures: The proportion of CAT score responders, Responders are defined as an improvement 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., 6 Weeks|Change from baseline in CAT score, 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., 12 Weeks|Change from baseline in CAT score, 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., 6 Weeks|Change from baseline in individual item CAT score, 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)., 12 Weeks|Change from baseline in individual item CAT score, 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)., 6 Weeks
Other Outcome Measures: Incidence of AEs, 12 Weeks|Change from baseline in blood pressure, 12 Weeks|Change rom Baseline in pulse rate, 12 Weeks