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| Name | Class |
|---|---|
| Midwest Chest Consultants | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensifentrine 3 mg twice daily | Drug | All subjects will receive ensifentrine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Blood Pressure in the Safety Analysis Set | Vital signs were assessed at baseline, week 6 and week 12. Week 12 is reported. Determine any clinically significant change from baseline in systolic and diastolic blood pressure. | 12 Weeks |
| Mean Change From Baseline in Pulse Rate in the Safety Analysis Set |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Chest Consultants | Saint Charles | Missouri | 63301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41710324 | Derived | 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. |
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There are no plans to make individual participant data available to other researchers.
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If any inclusion criteria were not met during screening at visit 1 or 2, the subject was not treated with study medication.
Study medication was dispensed and administered at visit 2 after all eligibility criteria were met.
Following the informed consent process, screening assessments were completed at visits 1 and 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ensifentrine 3 mg BID | Inhaled ensifentrine twice daily (BID) for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) therapy. Eligible subjects received ensifentrine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ensifentrine 3 mg BID | Inhaled ensifentrine twice daily (BID) for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) therapy. Eligible subjects received ensifentrine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | 12 Weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ensifentrine 3 mg BID | Inhaled ensifentrine twice daily (BID) for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) therapy. Eligible subjects received ensifentrine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | Verona Pharma | 844-341-9901 | clinicaltrials@veronapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2024 | Mar 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2024 | Mar 26, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C512996 | ensifentrine |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At week 6 and week 12 |
Vital signs were assessed at baseline, week 6 and week 12. Week 12 is reported. Determine any clinically significant change from baseline in pulse rate. |
| 12 Weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mean baseline CAT score | The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire completed 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. | Mean | Standard Deviation | units on a scale |
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Inhaled ensifentrine twice daily (BID) for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) therapy. Eligible subjects received ensifentrine. |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 Weeks |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Other Pre-specified | Mean Change From Baseline in Blood Pressure in the Safety Analysis Set | Vital signs were assessed at baseline, week 6 and week 12. Week 12 is reported. Determine any clinically significant change from baseline in systolic and diastolic blood pressure. | 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. | Posted | Mean | Standard Deviation | mmHg | 12 Weeks |
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| Other Pre-specified | Mean Change From Baseline in Pulse Rate in the Safety Analysis Set | Vital signs were assessed at baseline, week 6 and week 12. Week 12 is reported. Determine any clinically significant change from baseline in pulse rate. | 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. | Posted | Mean | Standard Deviation | bpm | 12 Weeks |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | At week 6 and week 12 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |