A Phase 3 interventional study of GSK573719 in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 20 sites in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.
Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action [Celli, 2004, GOLD 2009]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan.
In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 131 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Inclusion Criteria:
Exclusion Criteria (Visit 1):
Exclusion Criteria (Visit 2):
125mcg
Drug: GSK573719
GSK573719 inhalation powder inhaled orally once daily for 52 weeks.
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
Time frame: From the first dose of study medication up to 52 weeks
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
Time frame: From the first dose of study medication up to 52 weeks
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Change From BL in Blood Pressure Throughout the Treatment Period
Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
Time frame: BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Change From BL in Heart Rate Throughout the Treatment Period
Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
Time frame: BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
A total of 131 Japanese participants with chronic obstructive pulmonary disease (COPD) who met the eligibility criteria were registered and administration of investigational product was started
| Milestone | UMEC 125 µg QD |
|---|---|
| Started | 131 |
| Completed | 111 |
| Not completed | 20 |
| Withdrew: Adverse event | 14 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Withdrawal by subject | 2 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
| Participants | UMEC 125 µg QD |
|---|---|
| Any AE | 105 |
| Any SAE | 17 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
| Participants | UMEC 125 µg QD |
|---|---|
| Any AE, mild | 78 |
| Any AE, moderate | 18 |
| Any AE, severe | 9 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Percentage of cells in blood | UMEC 125 µg QD |
|---|---|
| Basophils, BL (Week -2), n=131 | 0.62 ± 0.462 |
| Basophils, Week 12, n=126 | 0.68 ± 0.494 |
| Basophils, Week 24, n=121 | 0.63 ± 0.433 |
| Basophils, Week 36, n=114 | 0.63 ± 0.391 |
| Basophils, Week 52, n=111 | 0.64 ± 0.455 |
| Basophils, WD Visit, n=15 | 0.61 ± 0.516 |
| Basophils, Week 24/WD, n=128 | 0.63 ± 0.446 |
| Basophils, Week 52/WD, n=126 | 0.63 ± 0.460 |
| Eosinophils, BL (Week -2), n=131 | 3.74 ± 3.573 |
| Eosinophils, Week 12, n=126 | 3.61 ± 2.451 |
| Eosinophils, Week 24, n=121 | 3.74 ± 3.453 |
| Eosinophils, Week 36, n=114 | 3.69 ± 2.903 |
| Eosinophils, Week 52, n=111 | 3.93 ± 4.188 |
| Eosinophils, WD Visit, n=15 | 2.94 ± 3.715 |
| Eosinophils, Week 24/WD, n=128 | 3.61 ± 3.424 |
| Eosinophils, Week 52/WD, n=126 | 3.81 ± 4.133 |
| Lymphocytes, BL (Week -2), n=131 | 30.96 ± 7.711 |
| Lymphocytes, Week 12, n=126 | 29.53 ± 7.340 |
| Lymphocytes, Week 24, n=121 | 29.98 ± 7.214 |
| Lymphocytes, Week 36, n=114 | 30.76 ± 6.840 |
| Lymphocytes, Week 52, n=111 | 29.87 ± 6.622 |
| Lymphocytes, WD Visit, n=15 | 23.58 ± 10.609 |
| Lymphocytes, Week 24/WD, n=128 | 29.26 ± 8.001 |
| Lymphocytes, Week 52/WD, n=126 | 29.12 ± 7.442 |
| Monocytes, BL (Week -2), n=131 | 6.35 ± 1.494 |
| Monocytes, Week 12, n=126 | 6.25 ± 1.516 |
| Monocytes, Week 24, n=121 | 6.39 ± 1.751 |
| Monocytes, Week 36, n=114 | 6.25 ± 1.539 |
| Monocytes, Week 52, n=111 | 6.45 ± 1.727 |
| Monocytes, WD Visit, n=15 | 5.83 ± 2.264 |
| Monocytes, Week 24/WD, n=128 | 6.34 ± 1.848 |
| Monocytes, Week 52/WD, n=126 | 6.38 ± 1.800 |
| Total Neutrophils, BL (Week -2), n=131 | 58.34 ± 7.818 |
| Total Neutrophils, Week 12, n=126 | 59.93 ± 8.065 |
| Total Neutrophils, Week 24, n=121 | 59.26 ± 8.273 |
| Total Neutrophils, Week 36, n=114 | 58.67 ± 7.219 |
| Total Neutrophils, Week 52, n=111 | 59.11 ± 7.107 |
| Total Neutrophils, WD Visit, n=15 | 67.04 ± 14.099 |
| Total Neutrophils, Week 24/WD, n=128 | 60.16 ± 9.378 |
| Total Neutrophils, Week 52/WD, n=126 | 60.05 ± 8.565 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| 10^9 cells per Liter (GI/L) | MEC 125 µg QD |
|---|---|
| Eosinophils, BL (Week -2), n=131 | 0.222 ± 0.1808 |
| Eosinophils, Week 12, n=126 | 0.213 ± 0.1426 |
| Eosinophils, Week 24, n=121 | 0.218 ± 0.1958 |
| Eosinophils, Week 36, n=114 | 0.215 ± 0.1542 |
| Eosinophils, Week 52, n=111 | 0.233 ± 0.2074 |
| Eosinophils, WD Visit, n=15 | 0.189 ± 0.2265 |
| Eosinophils, Week 24/WD, n=128 | 0.210 ± 0.1947 |
| Eosinophils, Week 52/WD, n=126 | 0.228 ± 0.2093 |
| Total Neutrophils, BL (Week -2), n=131 | 3.673 ± 1.1732 |
| Total Neutrophils, Week 12, n=126 | 3.705 ± 1.1894 |
| Total Neutrophils, Week 24, n=121 | 3.639 ± 1.2147 |
| Total Neutrophils, Week 36, n=114 | 3.576 ± 1.1978 |
| Total Neutrophils, Week 52, n=111 | 3.709 ± 1.1155 |
| Total Neutrophils, WD Visit, n=15 | 4.657 ± 2.3277 |
| Total Neutrophils, Week 24/WD, n=128 | 3.709 ± 1.4098 |
| Total Neutrophils, Week 52/WD, n=126 | 3.821 ± 1.3405 |
| Platelet Count, BL (Week -2), n=131 | 228.8 ± 55.42 |
| Platelet Count, Week 12, n=126 | 232.1 ± 57.03 |
| Platelet Count, Week 24, n=121 | 228.3 ± 53.74 |
| Platelet Count, Week 36, n=114 | 224.6 ± 51.22 |
| Platelet Count, Week 52, n=111 | 229.3 ± 52.38 |
| Platelet Count, WD Visit, n=15 | 217.3 ± 48.02 |
| Platelet Count, Week 24/WD, n=128 | 226.9 ± 54.03 |
| Platelet Count, Week 52/WD, n=126 | 227.9 ± 51.85 |
| WBC Count, BL (Week -2), n=131 | 6.24 ± 1.594 |
| WBC Count, Week 12, n=126 | 6.13 ± 1.549 |
| WBC Count, Week 24, n=121 | 6.07 ± 1.544 |
| WBC Count, Week 36, n=114 | 6.04 ± 1.552 |
| WBC Count, Week 52, n=111 | 6.23 ± 1.558 |
| WBC Count, WD Visit, n=15 | 6.87 ± 2.456 |
| WBC Count, Week 24/WD, n=128 | 6.08 ± 1.664 |
| WBC Count, Week 52/WD, n=126 | 6.31 ± 1.690 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Grams per Liter (G/L) | UMEC 125 µg QD |
|---|---|
| Hemoglobin, BL (Week -2), n=131 | 146.2 ± 13.66 |
| Hemoglobin, Week 12, n=126 | 147.4 ± 13.96 |
| Hemoglobin, Week 24, n=121 | 147.3 ± 13.59 |
| Hemoglobin, Week 36, n=114 | 145.6 ± 12.39 |
| Hemoglobin, Week 52, n=111 | 147.8 ± 13.39 |
| Hemoblobin, WD Visit, n=15 | 134.4 ± 13.92 |
| Hemoglobin, Week 24/WD, n=128 | 146.5 ± 14.19 |
| Hemoglobin, Week 52/WD, n=126 | 146.2 ± 14.09 |
| Albumin, BL (Week -2), n=131 | 41.9 ± 2.91 |
| Albumin, Week 12, n=126 | 42.5 ± 3.06 |
| Albumin, Week 24, n=121 | 42.3 ± 3.05 |
| Albumin, Week 36, n=114 | 42.3 ± 2.94 |
| Albumin, Week 52, n=111 | 42.6 ± 3.06 |
| Albumin, WD Visit, n=15 | 38.9 ± 3.13 |
| Albumin, Week 24/WD, n=128 | 42.1 ± 3.18 |
| Albumin, Week 52/WD, n=126 | 42.2 ± 3.29 |
| Total Protein, BL (Week -2), n=131 | 70.4 ± 4.05 |
| Total Protein, Week 12, n=126 | 70.9 ± 4.13 |
| Total Protein, Week 24, n=121 | 70.8 ± 4.09 |
| Total Protein, Week 36, n=114 | 70.0 ± 4.36 |
| Total Protein, Week 52, n=111 | 70.4 ± 4.42 |
| Total Protein, WD Visit, n=15 | 67.7 ± 4.67 |
| Total Protein, Week 24/WD, n=128 | 70.6 ± 4.23 |
| Total Protein, Week 52/WD, n=126 | 70.1 ± 4.52 |
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Proportion of red blood cells in blood | UMEC 125 µg QD |
|---|---|
| BL (Week -2), n=131 | 0.4457 ± 0.03961 |
| Week 12, n=126 | 0.4511 ± 0.04075 |
| Week 24, n=121 | 0.4513 ± 0.03895 |
| Week 36, n=114 | 0.4434 ± 0.03628 |
| Week 52, n=111 | 0.4419 ± 0.03726 |
| WD Visit, n=15 | 0.4124 ± 0.04371 |
| Week 24/WD, n=128 | 0.4484 ± 0.04108 |
| Week 52/WD, n=126 | 0.4384 ± 0.03909 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| International Units per Liter (IU/L) | UMEC 125 µg QD |
|---|---|
| AP, BL (Week -2), n=131 | 233.1 ± 61.19 |
| AP, Week 12, n=126 | 239.2 ± 68.51 |
| AP, Week 24, n=121 | 237.5 ± 63.33 |
| AP, Week 36, n=114 | 232.4 ± 65.73 |
| AP, Week 52, n=111 | 235.1 ± 64.83 |
| AP, WD Visit, n=15 | 258.0 ± 83.49 |
| AP, Week 24/WD, n=128 | 239.4 ± 67.27 |
| AP, Week 52/WD, n=126 | 237.8 ± 67.34 |
| ALT, BL (Week -2), n=131 | 21.1 ± 11.25 |
| ALT, Week 12, n=126 | 20.2 ± 9.70 |
| ALT, Week 24, n=121 | 19.9 ± 10.45 |
| ALT, Week 36, n=114 | 20.1 ± 11.94 |
| ALT, Week 52, n=111 | 20.7 ± 10.34 |
| ALT, WD Visit, n=15 | 23.9 ± 27.36 |
| ALT, Week 24/WD, n=128 | 20.5 ± 13.62 |
| ALT, Week 52/WD, n=126 | 21.1 ± 13.38 |
| AST, BL (Week -2), n=131 | 23.7 ± 11.72 |
| AST, Week 12, n=126 | 23.0 ± 8.46 |
| AST, Week 24, n=121 | 22.2 ± 7.12 |
| AST, Week 36, n=114 | 22.5 ± 11.72 |
| AST, Week 52, n=111 | 23.2 ± 8.10 |
| AST, WD Visit, n=15 | 28.7 ± 25.04 |
| AST, Week 24/WD, n=128 | 23.1 ± 10.97 |
| AST, Week 52/WD, n=126 | 23.8 ± 11.45 |
| Creatine Kinase, BL (Week -2), n=131 | 124.8 ± 71.56 |
| Creatine Kinase, Week 12, n=126 | 119.7 ± 92.39 |
| Creatine Kinase, Week 24, n=121 | 117.3 ± 70.74 |
| Creatine Kinase, Week 36, n=114 | 113.8 ± 70.26 |
| Creatine Kinase, Week 52, n=111 | 109.5 ± 60.10 |
| Creatine Kinase, WD Visit, n=15 | 144.7 ± 147.28 |
| Creatine Kinase, Week 24/WD, n=128 | 119.8 ± 82.66 |
| Creatine Kinase, Week 52/WD, n=126 | 113.7 ± 75.76 |
| GGT, BL (Week -2), n=131 | 40.1 ± 38.68 |
| GGT, Week 12, n=126 | 38.1 ± 34.09 |
| GGT, Week 24, n=121 | 39.5 ± 42.83 |
| GGT, Week 36, n=114 | 40.0 ± 44.18 |
| GGT, Week 52, n=111 | 42.2 ± 49.47 |
| GGT, WD Visit, n=15 | 49.5 ± 77.05 |
| GGT, Week 24/WD, n=128 | 40.9 ± 48.86 |
| GGT, Week 52/WD, n=126 | 43.1 ± 53.14 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Micromoles per Liter (µM/L) | UMEC 125 µg QD |
|---|---|
| Direct Bilirubin, BL (Week -2), n=131 | 3.577 ± 2.0172 |
| Direct Bilirubin, Week 12, n=126 | 3.284 ± 1.6699 |
| Direct Bilirubin, Week 24, n=121 | 3.137 ± 1.5508 |
| Direct Bilirubin, Week 36, n=114 | 3.450 ± 1.7323 |
| Direct Bilirubin, Week 52, n=111 | 3.389 ± 1.6783 |
| Direct Bilirubin, WD Visit, n=15 | 3.192 ± 1.4258 |
| Direct Bilirubin, Week 24/WD, n=128 | 3.153 ± 1.5539 |
| Direct Bilirubin, Week 52/WD, n=126 | 3.366 ± 1.6464 |
| Indirect Bilirubin, BL (Week -2), n=131 | 6.305 ± 2.8933 |
| Indirect Bilirubin, Week 12, n=126 | 6.664 ± 2.8271 |
| Indirect Bilirubin, Week 24, n=121 | 6.444 ± 2.8077 |
| Indirect Bilirubin, Week 36, n=114 | 6.975 ± 3.4662 |
| Indirect Bilirubin, Week 52, n=111 | 6.948 ± 3.0176 |
| Indirect Bilirubin, WD Visit, n=15 | 5.814 ± 3.0861 |
| Indirect Bilirubin, Week 24/WD, n=128 | 6.426 ± 2.8930 |
| Indirect Bilirubin, Week 52/WD, n=126 | 6.813 ± 3.0358 |
| Total Bilirubin, BL (Week -2), n=131 | 9.881 ± 4.4353 |
| Total Bilirubin, Week 12, n=126 | 9.948 ± 4.0720 |
| Total Bilirubin, Week 24, n=121 | 9.582 ± 3.9273 |
| Total Bilirubin, Week 36, n=114 | 10.425 ± 4.7718 |
| Total Bilirubin, Week 52, n=111 | 10.337 ± 4.3954 |
| Total Bilirubin, WD Visit, n=15 | 9.006 ± 4.3099 |
| Total Bilirubin, Week 24/WD, n=128 | 9.579 ± 4.0337 |
| Total Bilirubin, Week 52/WD, n=126 | 10.179 ± 4.3896 |
| Creatinine, BL (Week -2), n=131 | 73.1088 ± 15.62560 |
| Creatinine, Week 12, n=126 | 73.5965 ± 16.73127 |
| Creatinine, Week 24, n=121 | 73.1894 ± 15.82538 |
| Creatinine, Week 36, n=114 | 73.2092 ± 15.29351 |
| Creatinine, Week 52, n=111 | 72.3287 ± 14.54036 |
| Creatinine, WD Visit, n=15 | 78.0277 ± 26.02168 |
| Creatinine, Week 24/WD, n=128 | 73.3789 ± 16.14369 |
| Creatinine, Week 52/WD, n=126 | 73.0072 ± 16.28875 |
| Uric Acid, BL (Week -2), n=131 | 347.9353 ± 81.78271 |
| Uric Acid, Week 12, n=126 | 336.5813 ± 78.06630 |
| Uric Acid, Week 24, n=121 | 346.9011 ± 78.45280 |
| Uric Acid, Week 36, n=114 | 352.6016 ± 81.62589 |
| Uric Acid, Week 52, n=111 | 343.4836 ± 67.79140 |
| Uric Acid, WD Visit, n=15 | 343.3979 ± 96.73417 |
| Uric Acid, Week 24/WD, n=128 | 344.4264 ± 78.41134 |
| Uric Acid, Week 52/WD, n=126 | 343.4734 ± 71.35989 |
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Millimoles per Liter (MMOL/L) | UMEC 125 µg QD |
|---|---|
| Calcium, BL (Week -2), n=131 | 2.2804 ± 0.09567 |
| Calcium, Week 12, n=126 | 2.2720 ± 0.09628 |
| Calcium, Week 24, n=121 | 2.2589 ± 0.10287 |
| Calcium, Week 36, n=114 | 2.2505 ± 0.09407 |
| Calcium, Week 52, n=111 | 2.2680 ± 0.09580 |
| Calcium, WD Visit, n=15 | 2.1923 ± 0.09281 |
| Calcium, Week 24/WD, n=128 | 2.2556 ± 0.10334 |
| Calcium, Week 52/WD, n=126 | 2.2590 ± 0.09822 |
| Chloride, BL (Week -2), n=131 | 103.2 ± 2.58 |
| Chloride, Week 12, n=126 | 103.0 ± 2.61 |
| Chloride, Week 24, n=121 | 103.0 ± 2.89 |
| Chloride, Week 36, n=114 | 104.2 ± 3.26 |
| Chloride, Week 52, n=111 | 104.1 ± 2.74 |
| Chloride, WD Visit, n=15 | 104.1 ± 4.61 |
| Chloride, Week 24/WD, n=128 | 103.0 ± 3.06 |
| Chloride, Week 52/WD, n=126 | 104.1 ± 2.99 |
| Glucose, BL (Week -2), n=131 | 5.9980 ± 1.55438 |
| Glucose, Week 12, n=126 | 6.3127 ± 1.91203 |
| Glucose, Week 24, n=121 | 6.2735 ± 1.75968 |
| Glucose, Week 36, n=114 | 6.6047 ± 2.23873 |
| Glucose, Week 52, n=111 | 6.3957 ± 1.88553 |
| Glucose, WD Visit, n=15 | 6.9721 ± 2.28881 |
| Glucose, Week 24/WD, n=128 | 6.3364 ± 1.83801 |
| Glucose, Week 52/WD, n=126 | 6.4643 ± 1.93661 |
| CO2/HCO3, BL (Week -2), n=131 | 24.7 ± 1.95 |
| CO2/HCO3, Week 12, n=126 | 24.2 ± 1.85 |
| CO2/HCO3, Week 24, n=121 | 24.0 ± 2.17 |
| CO2/HCO3, Week 36, n=114 | 22.6 ± 2.18 |
| CO2/HCO3, Week 52, n=111 | 22.8 ± 2.16 |
| CO2/HCO3, WD Visit, n=15 | 22.9 ± 2.09 |
| CO2/HCO3, Week 24/WD, n=128 | 24.0 ± 2.14 |
| CO2/HCO3, Week 52/WD, n=126 | 22.8 ± 2.14 |
| Potassium, BL (Week -2), n=131 | 4.28 ± 0.322 |
| Potassium, Week 12, n=126 | 4.34 ± 0.309 |
| Potassium, Week 24, n=121 | 4.32 ± 0.359 |
| Potassium, Week 36, n=114 | 4.26 ± 0.345 |
| Potassium, Week 52, n=111 | 4.23 ± 0.325 |
| Potassium, WD Visit, n=15 | 4.21 ± 0.261 |
| Potassium, Week 24/WD, n=128 | 4.31 ± 0.355 |
| Potassium, Week 52/WD, n=126 | 4.23 ± 0.317 |
| Sodium, BL (Week -2), n=131 | 141.5 ± 1.99 |
| Sodium, Week 12, n=126 | 141.6 ± 1.97 |
| Sodium, Week 24, n=121 | 142.0 ± 1.98 |
| Sodium, Week 36, n=114 | 141.6 ± 1.90 |
| Sodium, Week 52, n=111 | 141.0 ± 1.95 |
| Sodium, WD Visit, n=15 | 140.8 ± 2.98 |
| Sodium, Week 24/WD, n=128 | 141.9 ± 2.17 |
| Sodium, Week 52/WD, n=126 | 141.0 ± 2.09 |
| Inorganic Phosphorus , BL (Week -2), n=131 | 0.9707 ± 0.14747 |
| Inorganic Phosphorus, Week 12, n=126 | 0.9731 ± 0.14204 |
| Inorganic Phosphorus, Week 24, n=121 | 0.9895 ± 0.14258 |
| Inorganic Phosphorus, Week 36, n=114 | 0.9942 ± 0.14571 |
| Inorganic Phosphorus, Week 52, n=111 | 0.9888 ± 0.15944 |
| Inorganic Phosphorus, WD Visit, n=15 | 0.9687 ± 0.18388 |
| Inorganic Phosphorus, Week 24/WD, n=128 | 0.9853 ± 0.14531 |
| Inorganic Phosphorus, Week 52/WD, n=126 | 0.9864 ± 0.16187 |
| Urea/BUN, BL (Week -2), n=131 | 5.2945 ± 1.72055 |
| Urea/BUN, Week 12, n=126 | 5.4556 ± 1.50863 |
| Urea/BUN, Week 24, n=121 | 5.4072 ± 1.44057 |
| Urea/BUN, Week 36, n=114 | 5.4386 ± 1.73080 |
| Urea/BUN, Week 52, n=111 | 5.1788 ± 1.37133 |
| Urea/BUN, WD Visit, n=15 | 6.2546 ± 2.28218 |
| Urea/BUN, Week 24/WD, n=128 | 5.4551 ± 1.48499 |
| Urea/BUN, Week 52/WD, n=126 | 5.3068 ± 1.53642 |
Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
| millimeters of mercury (mmHg) | UMEC 125 µg QD |
|---|---|
| SBP, Week 4, n=128 | 2.2 ± 12.47 |
| SBP, Week 8, n=127 | 4.1 ± 13.06 |
| SBP, Week 12, n=126 | 3.3 ± 15.14 |
| SBP, Week 24, n=121 | 2.6 ± 15.18 |
| SBP, Week 36, n=114 | -1.1 ± 16.78 |
| SBP, Week 52, n=111 | -0.5 ± 14.95 |
| SBP, WD Visit, n=17 | -2.4 ± 20.96 |
| SBP, Week 24/WD, n=129 | 2.0 ± 16.19 |
| SBP, Week 52/WD, n=128 | -0.8 ± 15.79 |
| DBP, Week 4, n=128 | 0.4 ± 9.98 |
| DBP, Week 8, n=127 | 1.6 ± 10.40 |
| DBP, Week 12, n=126 | 1.2 ± 10.63 |
| DBP, Week 24, n=121 | 1.3 ± 9.86 |
| DBP, Week 36, n=114 | -1.3 ± 11.24 |
| DBP, Week 52, n=111 | -1.3 ± 9.29 |
| DBP, WD Visit, n=17 | -0.4 ± 11.50 |
| DBP, Week 24/WD, n=129 | 0.9 ± 10.15 |
| DBP, Week 52/WD, n=128 | -1.2 ± 9.57 |
Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
| beats per minute | UMEC 125 µg QD |
|---|---|
| Week 4, n=128 | 0.1 ± 9.36 |
| Week 8, n=127 | -0.3 ± 11.07 |
| Week 12, n=126 | -1.4 ± 9.71 |
| Week 24, n=121 | -0.1 ± 9.42 |
| Week 36, n=114 | -1.8 ± 10.84 |
| Week 52, n=111 | -0.4 ± 9.72 |
| WD Visit, n=17 | 7.8 ± 30.78 |
| Week 24/WD, n=129 | 1.0 ± 14.17 |
| Week 52/WD, n=128 | 0.7 ± 14.46 |
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
| Participants | UMEC 125 µg QD |
|---|---|
| BL (Week -2) Abnormal NCS, n=131 | 57 |
| BL (Week -2), Abnormal CS, n=131 | 1 |
| Week 12, Abnormal NCS, n=126 | 55 |
| Week 12, Abnormal CS, n=126 | 0 |
| Week 24, Abnormal NCS, n=121 | 50 |
| Week 24, Abnormal CS, n=121 | 0 |
| Week 36, Abnormal NCS, n=114 | 45 |
| Week 36, Abnormal CS, n=114 | 0 |
| Week 52, Abnormal NCS, n=111 | 50 |
| Week 52, Abnormal CS, n=111 | 0 |
| WD Visit, Abnormal NCS, n=16 | 8 |
| WD Visit, Abnormal CS, n=16 | 1 |
| Week 24/WD, Abnormal NCS, n=128 | 53 |
| Week 24/WD, Abnormal CS, n=128 | 1 |
| Week 52/WD, Abnormal NCS, n=127 | 58 |
| Week 52/WD, Abnormal CS, n=127 | 1 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UMEC 125 µg QD | — | 17/131 (13%) | 71/131 (54.2%) |
| Event | UMEC 125 µg QD |
|---|---|
| PneumoniaInfections and infestations | 3/131 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 3/131 |
| OsteomyelitisInfections and infestations | 1/131 |
| Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 |
| Colon cancer stage 0Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 |
| Pneumothorax spontaneousRespiratory, thoracic and mediastinal disorders | 1/131 |
| Cerebellar haemorrhageNervous system disorders | 1/131 |
| Cerebral infarctionNervous system disorders | 1/131 |
| Event | UMEC 125 µg QD |
|---|---|
| NasopharyngitisInfections and infestations | 42/131 |
| ConstipationGastrointestinal disorders | 11/131 |
| BronchitisInfections and infestations | 10/131 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 10/131 |
| PharyngitisInfections and infestations | 9/131 |
| PneumoniaInfections and infestations | 9/131 |
| Age, Continuous(Years) | UMEC 125 µg QD |
|---|---|
| Mean | 69.2 ± 7.77 |
| Gender(Participants) | UMEC 125 µg QD |
|---|---|
| Female | 3 |
| Male | 128 |
| Race/Ethnicity, Customized(Participants) | UMEC 125 µg QD |
|---|---|
| Asian - Japanese Heritage | 131 |
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