A Phase 2 interventional study of YPL-001 80 mg and YPL-001 160 mg in Chronic Obstructive Pulmonary Disease, sponsored by Yungjin Pharm. Co., Ltd.. Completed at 4 sites in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Yungjin Pharm. Co., Ltd. · Phase 2, Interventional, and Treatment
This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Treatments are described as follows:
Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment B: Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment C: Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56. In all treatments, one tiotropium (Spiriva® HandiHaler®) 18 μg capsule will also be administered QD every morning prior to study drugs administration. Albuterol will be administered on an as needed basis. Each dose of Treatments A, B and C will be administered orally with approximately 240 mL of water.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 61 is close to the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Yungjin Pharm. Co., Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
Drug: YPL-001 80 mg
Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
Drug: YPL-001 160 mg
Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days.
Drug: Placebo
twice daily \[BID\]
Also known as: Treatment A
twice daily \[BID\]
Also known as: Treatment B
twice daily \[BID\]
Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
Time frame: Up to Day 56
Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
Time frame: Up to Day 56
Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
Time frame: Up to Day 56
Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
Time frame: Up to Day 56
Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily
The PEF assessments are made daily prior to each dose from Day 1 of the Run-in Period to Day 56 of the Treatment Period. Three measurements were made at each time point using a hand held PEF meter. Readings not performed in the clinical research unit (CRU) were recorded in the patient e-diary. All PEF assessments were performed before administration of a bronchodilator where possible. Baseline is Day 1 predose measurement.
Time frame: Baseline to Day 55
Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Patient is asked to record the major (sputum quality, color, consistency) and minor (cough, wheeze, sore throat, nasal congestion, discharge, and body temperature above 100°F) symptoms of COPD exacerbation via the e-diary before each dosing. Baseline is Day 1 predose measurement 1. Breathlessness(Dyspnea) Screen: 0(None)-10(Extreme): 0: better condition, 10: worse condition 2. Sputum Quantity Screen: None(better)-greater than 1/4 cup(worse) 3. Sputum Color Screen: White(better)-Brown(condition) 4. Sputum Consistency Screen: Watery(better)-Thick(worse) 5. Peak Flow Measurement Screen: 60(better)-800(worse) 6. Symptoms Screen: (Temperature over 100F / Cough/Wheeze/Sore Throat/ Nasal Congestion) 7. Nasal Discharge Screen(Yes/No) \* quantitative data were summarized including sample size, arithmetic mean, standard deviation, CV, min and max. Symptom score catecorizes normal(0-0.5), mild(1-1.5), moderate(2-2.5), severe(3-3.5)
Time frame: Baseline to Day 55
Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale)
Severity level of patient's dyspnea is accessed via the modified Borg dyspnea scale programmed within the e-diary. The modified Borg dyspnea scale is a self-administered categorical scale with a score from 0 to 10, where 0 (as a measure of dyspnea) corresponds to the sensation of normal breathing (absence of dyspnea) and 10 corresponds to the patient's maximum possible sensation of dyspnea.
Time frame: Baseline to Day 55
Change From Baseline of Calculated Score From Duke Activity Status Index (DASI)
Patient's functional capacity and activity status were accessed via the DASI programmed within the e-diary. DASI is a self-administered 12-item questionnaire that assesses daily activities such as personal care, ambulation, household tasks, sexual function and recreation with respective metabolic costs. Each item has a specific weight based on the metabolic cost. The final score ranges between 0 and 58.2 points. The higher score shows the better the functional capacity.
Time frame: Baseline to Day 55
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: Baseline (Screen) to Day 55
Change From Baseline in Inspiratory Capacity (IC)
Inspiratory capacity (IC) is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. IC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation.
Time frame: Baseline (Screening) to Day 55
Change From Baseline in Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).
Time frame: Baseline to Day 55
Transition Dyspnea Index (TDI) Focal Score
Dyspnea at baseline (Day -1) will be assessed with the Baseline Dyspnea Index (BDI). This instrument has 3 domains (functional impairment, magnitude of task and magnitude of effort) with the values added for a combined focal score. Functional impairment determines the impact of breathlessness on the ability to carry out activities; magnitude of task determines the type of task that causes breathlessness, magnitude of effort establishes the level of effort that results in breathlessness. The BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (0 to 12). Dyspnea throughout the study will be performed at the time points. The change from baseline is measured by the Transition Dyspnea Index (TDI) score which ranges from -3 (major deterioration) to +3 (major improvement) for each domain with the TDI focal score consisting in the sum of each domain (-9 to +9).
Time frame: Baseline to Day 55
Change From Baseline in Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
The chronic obstructive pulmonary disease assessment test (CAT) is a short and simple questionnaire of 8 items completed by patients to be performed at the time points. Scores for each of the 8 items are summed to give a single, final score ranging from 0 (no impact on daily activities) to 40 (very high impact on daily activity).
Time frame: Baseline to Day 55
Change in Percentage of Total Cells in Bronchoalveolar Lavage (BAL)
The bronchoalveolar lavage (BAL) samples were collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are at analyzed for total cell count (cells/mL) of white blood cell, macrophages, lymphocytes, neutrophils, and eosinophils as a percentage of total cells.
Time frame: Baseline (Day -1) and Day 55
Change in Concentrations of Inflammatory Marker in Bronchoalveolar Lavage (BAL)
The bronchoalveolar lavage (BAL) samples are collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are analyzed for concentrations of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1β, IL-4, IL-5, IL-6, IL-8, IL-13, Myeloperoxidase (MPO), neutrophil elastase (ELA2), monocyte chemotactic protein-1 (MCP-1), myeloperoxidase(MPO), and matrix metalloproteinase-9 (MMP-9).
Time frame: Baseline (Day -1) and Day 55
Change in Percentage of Total Cells in Blood
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for inflammatory markers (total and differential cell counts as absolute and percentage for neutrophils, macrophages, eosinophils and lymphocytes).
Time frame: Baseline to Day 55
Change in Concentrations of Inflammatory Marker in Plasma/Blood
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for concentrations of C-reactive protein (CRP), fibrinogen, TNF-α, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-13, MCP-1, and MMP-9. Baseline is Day 1 predose measurement.
Time frame: Baseline to Day 55
Number of Participants With COPD Exacerbation
Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.
Time frame: Baseline to Day 56
Change From Baseline in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FVC indicates improvement in lung function.
Time frame: Baseline (Screen) to Day 55
| Milestone | YPL-001 Low Dose | YPL-001 High Dose | Placebo |
|---|---|---|---|
| Started | 20 | 21 | 20 |
| Completed | 19 | 20 | 19 |
| Not completed | 1 | 1 | 1 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Patients With AEs | 10 | 8 | 14 |
| Number of Patients Without AEs | 10 | 13 | 6 |
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
| Adverse events | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Total Number of AEs | 18 | 14 | 23 |
| Eye disorders | 1 | 1 | 0 |
| Gastrointestinal disorders | 3 | 1 | 1 |
| Infections and infestations | 5 | 3 | 6 |
| Injury, poisoning and procedural complications | 0 | 0 | 2 |
| Metabolism and nutrition disorders | 1 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 1 | 2 | 0 |
| Nervous system disorders | 0 | 1 | 0 |
| Respiratory, thoracic and mediastinal disorders | 5 | 4 | 13 |
| Skin and subcutaneous tissue disorders | 0 | 1 | 1 |
| Surgical and medical procedures | 1 | 1 | 0 |
| Vascular disorders | 1 | 0 | 0 |
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
| participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Patients With AEs | 10 | 8 | 14 |
| Severity: Mild | 3 | 3 | 4 |
| Severity: Moderate | 7 | 5 | 9 |
| Severity: Severe | 0 | 0 | 1 |
| Relationship to Drug: Unrelated | 9 | 7 | 14 |
| Relationship to Drug: Unlikely | 0 | 1 | 0 |
| Relationship to Drug: Possible | 1 | 0 | 0 |
| Relationship to Drug: Probable | 0 | 0 | 0 |
| Relationship to Drug: Definite | 0 | 0 | 0 |
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
| Adverse events | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Adverse Events | 18 | 14 | 23 |
| Severity: Mild | 9 | 8 | 11 |
| Severity: Moderate | 9 | 6 | 11 |
| Severity: Severe | 0 | 0 | 1 |
| Relationship to Drug: Unrelated | 17 | 12 | 23 |
| Relationship to Drug: Unlikely | 0 | 2 | 0 |
| Relationship to Drug: Possible | 1 | 0 | 0 |
| Relationship to Drug: Probable | 0 | 0 | 0 |
| Relationship to Drug: Definite | 0 | 0 | 0 |
The PEF assessments are made daily prior to each dose from Day 1 of the Run-in Period to Day 56 of the Treatment Period. Three measurements were made at each time point using a hand held PEF meter. Readings not performed in the clinical research unit (CRU) were recorded in the patient e-diary. All PEF assessments were performed before administration of a bronchodilator where possible. Baseline is Day 1 predose measurement.
| L/min | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Baseline (Day1) | 250.0 ± 109.82 | 254.9 ± 68.61 | 240.7 ± 68.21 |
| Day55 | 282.8 ± 123.61 | 277.9 ± 92.08 | 247.6 ± 96.17 |
Patient is asked to record the major (sputum quality, color, consistency) and minor (cough, wheeze, sore throat, nasal congestion, discharge, and body temperature above 100°F) symptoms of COPD exacerbation via the e-diary before each dosing. Baseline is Day 1 predose measurement 1. Breathlessness(Dyspnea) Screen: 0(None)-10(Extreme): 0: better condition, 10: worse condition 2. Sputum Quantity Screen: None(better)-greater than 1/4 cup(worse) 3. Sputum Color Screen: White(better)-Brown(condition) 4. Sputum Consistency Screen: Watery(better)-Thick(worse) 5. Peak Flow Measurement Screen: 60(better)-800(worse) 6. Symptoms Screen: (Temperature over 100F / Cough/Wheeze/Sore Throat/ Nasal Congestion) 7. Nasal Discharge Screen(Yes/No) \* quantitative data were summarized including sample size, arithmetic mean, standard deviation, CV, min and max. Symptom score catecorizes normal(0-0.5), mild(1-1.5), moderate(2-2.5), severe(3-3.5)
| score on a scale | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Baseline (Day 1) | 0.63 ± 0.812 | 0.17 ± 0.297 | 0.47 ± 0.757 |
| Day 55 | 0.26 ± 0.504 | 0.18 ± 0.351 | 0.50 ± 0.876 |
Severity level of patient's dyspnea is accessed via the modified Borg dyspnea scale programmed within the e-diary. The modified Borg dyspnea scale is a self-administered categorical scale with a score from 0 to 10, where 0 (as a measure of dyspnea) corresponds to the sensation of normal breathing (absence of dyspnea) and 10 corresponds to the patient's maximum possible sensation of dyspnea.
| units on a scale | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Baseline (Day 1) | 3.88 ± 1.996 | 4.05 ± 1.746 | 3.18 ± 2.512 |
| Day 55 | 3.76 ± 2.463 | 3.88 ± 2.147 | 3.31 ± 2.323 |
Patient's functional capacity and activity status were accessed via the DASI programmed within the e-diary. DASI is a self-administered 12-item questionnaire that assesses daily activities such as personal care, ambulation, household tasks, sexual function and recreation with respective metabolic costs. Each item has a specific weight based on the metabolic cost. The final score ranges between 0 and 58.2 points. The higher score shows the better the functional capacity.
| score on a scale | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline of Calculated Score From Duke Activity Status Index (DASI) | -0.267 ± 3.7696 | -2.844 ± 9.8016 | 1.137 ± 4.8336 |
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FEV1 indicates improvement in lung function.
| L | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | -0.088 ± 0.2721 | -0.002 ± 0.1974 | 0.011 ± 0.1533 |
Inspiratory capacity (IC) is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. IC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation.
| L | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline in Inspiratory Capacity (IC) | -0.158 ± 0.3148 | -0.097 ± 0.4357 | -0.304 ± 0.4709 |
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).
| ratio | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio | -1.8 ± 6.21 | -0.2 ± 4.63 | 2.0 ± 4.98 |
Dyspnea at baseline (Day -1) will be assessed with the Baseline Dyspnea Index (BDI). This instrument has 3 domains (functional impairment, magnitude of task and magnitude of effort) with the values added for a combined focal score. Functional impairment determines the impact of breathlessness on the ability to carry out activities; magnitude of task determines the type of task that causes breathlessness, magnitude of effort establishes the level of effort that results in breathlessness. The BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (0 to 12). Dyspnea throughout the study will be performed at the time points. The change from baseline is measured by the Transition Dyspnea Index (TDI) score which ranges from -3 (major deterioration) to +3 (major improvement) for each domain with the TDI focal score consisting in the sum of each domain (-9 to +9).
| units on a scale | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Transition Dyspnea Index (TDI) Focal Score | 2.2 ± 2.68 | 1.1 ± 2.75 | 2.9 ± 2.84 |
The chronic obstructive pulmonary disease assessment test (CAT) is a short and simple questionnaire of 8 items completed by patients to be performed at the time points. Scores for each of the 8 items are summed to give a single, final score ranging from 0 (no impact on daily activities) to 40 (very high impact on daily activity).
| units on a scale | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) | -1.2 ± 6.14 | -1.3 ± 5.11 | 0.0 ± 7.38 |
The bronchoalveolar lavage (BAL) samples were collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are at analyzed for total cell count (cells/mL) of white blood cell, macrophages, lymphocytes, neutrophils, and eosinophils as a percentage of total cells.
| percent change from baseline | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| WBC | 5.2 ± 23.16 | -2.3 ± 22.87 | -5.6 ± 21.16 |
| Eosinohils | -50.8 ± 49.25 | 38.3 ± 150.97 | 61.2 ± 261.73 |
| Lymphocytes | 37.8 ± 111.26 | 2.7 ± 75.89 | 19.4 ± 121.45 |
| Macrophages | 45.9 ± 136.88 | 9.3 ± 55.48 | 59.8 ± 124.05 |
| Neutrophils | 57.0 ± 152.70 | 83.5 ± 252.98 | 1.1 ± 106.19 |
The bronchoalveolar lavage (BAL) samples are collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are analyzed for concentrations of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1β, IL-4, IL-5, IL-6, IL-8, IL-13, Myeloperoxidase (MPO), neutrophil elastase (ELA2), monocyte chemotactic protein-1 (MCP-1), myeloperoxidase(MPO), and matrix metalloproteinase-9 (MMP-9).
| % change from baseline | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| ELA2(neutrophil elastage) | 46.36 ± 154.476 | 714.18 ± 1864.367 | 155.57 ± 523.538 |
| IL-13 | 34.47 ± 187.126 | 321.42 ± 1168.485 | 160.25 ± 243.317 |
| IL-1ß | 79.65 ± 216.674 | 223.62 ± 618.896 | 45.43 ± 207.504 |
| IL-4 | 11.12 ± 101.995 | 121.13 ± 258.496 | 155.36 ± 276.287 |
| IL-5 | 49.97 ± 161.255 | 220.88 ± 523.979 | 213.86 ± 341.157 |
| IL-6 | -7.41 ± 79.289 | 130.15 ± 354.531 | 53.48 ± 153.791 |
| IL-8 | 50.61 ± 178.116 | 173.57 ± 600.987 | 45.40 ± 222.303 |
| MCP-1 | 90.05 ± 224.213 | 155.50 ± 601.606 | 252.95 ± 816.196 |
| MMP-9 | 28.38 ± 201.899 | 565.88 ± 2067.142 | 43.31 ± 242.912 |
| MPO | 64.14 ± 243.237 | 275.50 ± 693.932 | 62.14 ± 199.545 |
| TNF-a | 14.04 ± 114.456 | 268.19 ± 863.815 | 124.20 ± 266.423 |
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for inflammatory markers (total and differential cell counts as absolute and percentage for neutrophils, macrophages, eosinophils and lymphocytes).
| % change from baseline | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| WBC | 5.229 ± 23.1568 | -2.289 ± 22.8687 | -5.572 ± 21.1569 |
| Eosinophils | 7.61728 ± 78.203389 | 20.06903 ± 91.240833 | 57.36857 ± 226.50576 |
| Lymphocytes | 10.21926 ± 35.449159 | -1.58746 ± 23.455210 | 14.24407 ± 26.363322 |
| Monocytes | 0.05858 ± 24.446709 | 30.65211 ± 65.329419 | 1.67563 ± 46.936967 |
| Neutrophils | 1.62215 ± 24.058407 | 0.13700 ± 10.8890617 | -3.29570 ± 10.559662 |
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for concentrations of C-reactive protein (CRP), fibrinogen, TNF-α, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-13, MCP-1, and MMP-9. Baseline is Day 1 predose measurement.
| % change from baseline | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| ELA2 | -7.13 ± 30.726 | -17.01 ± 33.050 | -26.33 ± 30.972 |
| IL-13 | 5.158 ± 45.4151 | 10.197 ± 53.7029 | -1.622 ± 5.5691 |
| IL-1ß | 44.9813 ± 149.88595 | 32.7901 ± 121.71539 | 4.7453 ± 72.39394 |
| IL-4 | 68.849 ± 280.7619 | 22.678 ± 98.3923 | -19.865 ± 35.6127 |
| IL-5 | 73.36 ± 214.724 | 20.57 ± 257.416 | -5.30 ± 99.117 |
| IL-6 | -26.0682 ± 36.92257 | -35.8383 ± 82.30541 | -48.4230 ± 51.59468 |
| IL-8 | 26.916 ± 47.0832 | 6.986 ± 54.7421 | 57.464 ± 176.8141 |
| MCP1 | 20.019 ± 86.8398 | -13.923 ± 31.9128 | 51.441 ± 173.5531 |
| MMP9 | -10.922 ± 52.3542 | -9.087 ± 39.4842 | -27.524 ± 34.8440 |
| MPO | -6.051 ± 21.3202 | -9.661 ± 26.7605 | -14.232 ± 26.6217 |
| TNF-α | -10.499 ± 24.7753 | -16.184 ± 25.6551 | -1.585 ± 27.5520 |
| CRP | -12.087 ± 102.3304 | 29.028 ± 345.0216 | -61.732 ± 40.0405 |
| Fibrinogen | 0.5 ± 15.39 | -0.4 ± 13.88 | -7.7 ± 22.38 |
Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With COPD Exacerbation | 3 | 2 | 5 |
Forced vital capacity (FVC) is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FVC indicates improvement in lung function.
| L | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) | -0.087 ± 0.3475 | 0.007 ± 0.2290 | -0.105 ± 0.3117 |
Collected over 56 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | 0/20 (0%) | 0/20 (0%) | 10/20 (50%) |
| Treatment B | 0/21 (0%) | 0/21 (0%) | 8/21 (38.1%) |
| Treatment C | 0/20 (0%) | 1/20 (5%) | 14/20 (70%) |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Acute Exacerbation of COPDRespiratory, thoracic and mediastinal disorders | 0/20 | 0/21 | 1/20 |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 3/20 | 2/21 | 5/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/20 | 2/21 | 5/20 |
| Upper respiratory tract infectionInfections and infestations | 0/20 | 0/21 | 2/20 |
| Urinary tract infectionInfections and infestations | 1/20 | 2/21 | 0/20 |
| Dry eyeEye disorders | 1/20 | 0/21 | 0/20 |
| DiarrhoeaGastrointestinal disorders | 1/20 | 0/21 | 0/20 |
| Dry mouthGastrointestinal disorders | 0/20 | 0/21 | 1/20 |
| DyspepsiaGastrointestinal disorders | 1/20 | 0/21 | 0/20 |
| NauseaGastrointestinal disorders | 1/20 | 0/21 | 0/20 |
| BronchitisInfections and infestations | 1/20 | 0/21 | 1/20 |
All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo.
| Age, Continuous(years) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Mean | 65.7 ± 8.66 | 60.4 ± 6.50 | 61.7 ± 7.95 | 62.6 ± 7.98 |
| Sex: Female, Male(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Female | 8 | 8 | 9 | 25 |
| Male | 12 | 13 | 11 | 36 |
| Ethnicity (NIH/OMB)(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 19 | 21 | 20 | 60 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 6 | 5 | 16 |
| White | 15 | 15 | 15 | 45 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| United States | 20 | 21 | 20 | 61 |
| Body mass index(kg/m²) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Mean | 28.34 ± 4.759 | 27.77 ± 3.838 | 26.19 ± 4.711 | 27.44 ± 4.465 |
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Yungjin Pharm. Co., Ltd.