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The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.
Several studies have demonstrated the efficacy and safety of combining an individual LABA compound plus an individual LAMA compound in COPD. These studies have shown the combination of these two products to be superior to either agent alone on a variety of outcomes in COPD. The beneficial effects of this combination regimen are likely due to the different mechanisms of action of the two bronchodilators (smooth bronchial muscle relaxation from activation of beta2 receptors from the LABA product and inhibition of acetylcholine-mediated smooth bronchial muscle contraction via blockade of muscarinic receptors from the LAMA product). The availability of a LABA/LAMA combination in one product instead of two individual products is a technical and therapeutic advancement in the pharmacological armamentarium for COPD and may lead to increased patient compliance due to once-daily administration. The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication, and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control. All treatments will be delivered once-daily via the nDPI. This study will establish the long-term safety profile of GSK573719/GW642444 Inhalation Powder 125/25mcg once-daily in subjects with COPD. The safety profile of GSK573719 Inhalation Powder125mcg once-daily will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK573719/GW642444 | Experimental | 125/25 mcg once-daily |
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| GSK573719 | Experimental | 125 mcg once-daily |
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| Placebo | Placebo Comparator | inactive |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 125/25 mcg once-daily GSK573719/GW642444 | Drug | GSK573719/GW642444 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs. | From the start of study drug up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization. | From the start of study drug up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113359 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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The study consisted of a Run-in Period of 7 to10 days, followed by a 52-week Treatment Period. A total of 893 participants were screened; of these, 312 were screen failures, 19 were Run-in failures, 563 were randomized, and 562 received at least one dose of study drug (one participant was randomized in error but did not receive study drug).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks. |
| FG001 | UMEC 125 µg | Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 125mcg once-daily GSK573719 |
| Drug |
GSK573719 |
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| Placebo once-daily | Drug | inactive |
|
| Time to the First On-treatment COPD Exacerbation |
An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants. |
| From the start of study drug up to 52 weeks |
| Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | Baseline; Months 3, 6, 9, and 12 |
| Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period | Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; from the start of study drug up to 52 weeks |
| Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; from the start of study drug up to 52 weeks |
| Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week | 12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; from the start of study drug up to 52 weeks |
| Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | 12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; from the start of study drug up to 52 weeks |
| Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists. | From the start of study drug up to 52 weeks |
| Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An "any time post-Baseline" Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists. | Screening; from the start of study drug up to 52 weeks |
| Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period | Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group. | Baseline; from the start of study drug up to 52 weeks |
| Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline. | From the start of study drug up to 52 weeks |
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12 | FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning's dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions. | Baseline; Months 1, 3, 6, 9, and 12 |
| Sunset |
| Louisiana |
| 70584 |
| United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Columbus | Ohio | 43215 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Union | South Carolina | 29379 | United States |
| GSK Investigational Site | Corsicana | Texas | 75110 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Morgantown | West Virginia | 26505 | United States |
| GSK Investigational Site | Puente Alto - Santiago | Región Metro de Santiago | 8207257 | Chile |
| GSK Investigational Site | Talca | Región Metro de Santiago | 3460001 | Chile |
| GSK Investigational Site | Santiago | 8380453 | Chile |
| GSK Investigational Site | Bacau | 600252 | Romania |
| GSK Investigational Site | Brasov | 500112 | Romania |
| GSK Investigational Site | Brasov | 500283 | Romania |
| GSK Investigational Site | Bucharest | 70000 | Romania |
| GSK Investigational Site | Piteşti | 110084 | Romania |
| GSK Investigational Site | Ploieşti | 100172 | Romania |
| GSK Investigational Site | Ploieşti | 100379 | Romania |
| GSK Investigational Site | Timișoara | 300310 | Romania |
| GSK Investigational Site | Ivanovo | 153005 | Russia |
| GSK Investigational Site | Moscow | 119 048 | Russia |
| GSK Investigational Site | Moscow | 127018 | Russia |
| GSK Investigational Site | Penza | 440067 | Russia |
| GSK Investigational Site | Saint Petersburg | 193231 | Russia |
| GSK Investigational Site | Saint Petersburg | 194354 | Russia |
| GSK Investigational Site | Shakhty, Rostov Region | 346510 | Russia |
| GSK Investigational Site | Sochi | 354057 | Russia |
| GSK Investigational Site | St'Petersburg | 197706 | Russia |
| GSK Investigational Site | Tomsk | 634 050 | Russia |
| GSK Investigational Site | Tyumen | 625023 | Russia |
| GSK Investigational Site | Veliky Novgorod | 173008 | Russia |
| GSK Investigational Site | Vladivostok | 690950 | Russia |
| GSK Investigational Site | Yekaterinburg | 620109 | Russia |
| GSK Investigational Site | Bratislava | 826 06 | Slovakia |
| GSK Investigational Site | Bratislava | 841 08 | Slovakia |
| GSK Investigational Site | Poprad | 058 01 | Slovakia |
| GSK Investigational Site | Považská Bystrica | 017 26 | Slovakia |
| GSK Investigational Site | Šaľa | 927 01 | Slovakia |
| GSK Investigational Site | Žilina | 012 07 | Slovakia |
| GSK Investigational Site | Benoni | Gauteng | 1501 | South Africa |
| GSK Investigational Site | Bellville | 7530 | South Africa |
| GSK Investigational Site | Bloemfontein | 9301 | South Africa |
| GSK Investigational Site | Durban | 4001 | South Africa |
| GSK Investigational Site | Gatesville | 7764 | South Africa |
| GSK Investigational Site | Mowbray | 7700 | South Africa |
| GSK Investigational Site | Somerset West | 7130 | South Africa |
| GSK Investigational Site | Tygerberg | 7505 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113359 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks. |
| BG001 | UMEC 125 µg | Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks. |
| BG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||
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| Primary | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs. | Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug | Posted | Number | Participants | From the start of study drug up to 52 weeks |
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| Secondary | Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization. | ITT Population | Posted | Number | Participants | From the start of study drug up to 52 weeks |
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| Secondary | Time to the First On-treatment COPD Exacerbation | An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants. | ITT Population | Posted | Median | Full Range | Days | From the start of study drug up to 52 weeks |
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| Secondary | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Micromoles per liter (µmol/L) | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Percentage in blood | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter (GI/L) | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit. | ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population. | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline; Months 3, 6, 9, and 12 |
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| Secondary | Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period | Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline; from the start of study drug up to 52 weeks |
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| Secondary | Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline; from the start of study drug up to 52 weeks |
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| Secondary | Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week | 12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Milliseconds | Baseline; from the start of study drug up to 52 weeks |
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| Secondary | Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | 12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline; from the start of study drug up to 52 weeks |
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| Secondary | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists. | ITT Population | Posted | Number | participants | From the start of study drug up to 52 weeks |
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| Secondary | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An "any time post-Baseline" Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists. | ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized. | Posted | Number | Participants | Screening; from the start of study drug up to 52 weeks |
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| Secondary | Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period | Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group. | ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis. | Posted | Least Squares Mean | Standard Error | Number of puffs per day | Baseline; from the start of study drug up to 52 weeks |
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| Secondary | Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline. | ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary. | Posted | Mean | Standard Deviation | Percentage of rescue-free days | From the start of study drug up to 52 weeks |
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| Secondary | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12 | FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning's dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions. | ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles. | Posted | Least Squares Mean | Standard Error | Liters | Baseline; Months 1, 3, 6, 9, and 12 |
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On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve | 7 | 109 | 34 | 109 | ||
| EG001 | UMEC 125 µg | Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks. | 17 | 227 | 78 | 227 | ||
| EG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. | 14 | 226 | 65 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial fibrosis | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Rhythm idioventricular | Cardiac disorders | MedDRA | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Psychomotor hyperactivity | Nervous system disorders | MedDRA | Systematic Assessment |
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| Peptic ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Clostridium test positive | Investigations | MedDRA | Systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Skin graft | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
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| Extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Japanese/East Asian HER/South East Asian HER |
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| White |
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| Male |
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| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| UMEC/VI 125/25µg |
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| UMEC/VI 125/25 µg |
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | UMEC/VI 125/25 µg | Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks. |
|
|