Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, nDPI, long-acting beta agonist, long-acting muscarinic antagonist, tolerability, safety
Brief summary
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.
Detailed description
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.
Interventions
DRUG125/25 mcg once-daily GSK573719/GW642444
GSK573719/GW642444
DRUG125mcg once-daily GSK573719
GSK573719
DRUGPlacebo once-daily
inactive
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* outpatient * signed and dated written informed consent * 40 years of age or older * male and female subjects * COPD diagnosis * at least 10 pack-year smoking history * post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 and post-albuterol/salbutamol FEV1 greater than or equal to 35% and less than or equal to 80% of predicted normal
Exclusion criteria
* Pregant or lactating women or women planning to become pregnant during the study * current diagnosis of asthma * other respiratory disorders other than COPD * other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years * chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD * hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics * hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1 * lung volume reduction surgery within 12 months prior to Visit 1 * abnormal and clinically significant ECG at Visit 1 * abnormal and clinically significant Holter monitor finding at Visit 1 * significantly abnormal finding from laboratory tests at Visit 1 * unable to withhold albuterol/salbutamol and/or ipratropium bromide at least 4 hours prior to spirometry at each visit * use of depot corticosteroids within 12 weeks of Visit 1 * use of oral or parenteral corticosteroids within 6 weeks of Visit 1 * use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1 * use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1 * us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1 * use of ICS at a dose of \>10000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1 * initiation or discontinuation of ICS within 30 days of Visit 1 * use of tiotropium within 14 days of Visit 1 * use of roflumilast within 14 days of Visit 1 * use of theophyllines within 48 hours of Visit 1 * use of oral leukotriene inhibitors within 48 hours prior to Visit 1 * use of long-acting oral beta-agonists within 48 hours of Visit 1 * use of short-acting oral beta-agonists within 12 hours of Visit 1 * use of inhaled long-acting beta-agonists within 48 hours prior to Visit 1 * use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component * use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1 * use of inhaled short acting beta-agonists within 4 hours of Visit 1 * use of inhaled short-acting anticholinergics within 4 hours of Visit 1 * use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours of Visit 1 * use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) of Visit 1 * long-term oxygen therapy prescribed for \>12 hours per day * regular use of short-acting bronchodilators * use of CPAP or NIPPV * participation in the maintenance phase of a pulmonary rehabilitation program * known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1 * anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.) * previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | From the start of study drug up to 52 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the First On-treatment COPD Exacerbation | From the start of study drug up to 52 weeks | 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. |
| 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 | Baseline; 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. |
| Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Baseline; 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. |
| 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 | Baseline; 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. |
| Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Baseline; 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. |
| Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Baseline; 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. |
| Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Baseline; 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. |
| Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Baseline; 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. |
| Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | From the start of study drug up to 52 weeks | A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization. |
| Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | Baseline; from the start of study drug up to 52 weeks | 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. |
| 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 | Baseline; from the start of study drug up to 52 weeks | 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. |
| Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | Baseline; from the start of study drug up to 52 weeks | 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. |
| Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | From the start of study drug up to 52 weeks | 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. |
| Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Screening; from the start of study drug up to 52 weeks | 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. |
| 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 | Baseline; from the start of study drug up to 52 weeks | 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. |
| Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | From the start of study drug up to 52 weeks | 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. |
| 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 | Baseline; 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. |
| 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; from the start of study drug up to 52 weeks | 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. |
Countries
Chile, Romania, Russia, Slovakia, South Africa, United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks. | 109 |
| UMEC 125 µg Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks. | 227 |
| 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. | 226 |
| Total | 562 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 21 | 17 |
| Overall Study | Lack of Efficacy | 9 | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 7 | 5 |
| Overall Study | Protocol-defined Stopping Criteria | 8 | 37 | 36 |
| Overall Study | Protocol Violation | 2 | 6 | 6 |
| Overall Study | Study Closed/Terminated | 2 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 8 | 16 | 15 |
Baseline characteristics
| Characteristic | Placebo | UMEC 125 µg | UMEC/VI 125/25 µg | Total |
|---|---|---|---|---|
| Age, Continuous | 60.1 Years STANDARD_DEVIATION 8.28 | 61.7 Years STANDARD_DEVIATION 9.1 | 61.4 Years STANDARD_DEVIATION 9.01 | 61.3 Years STANDARD_DEVIATION 8.92 |
| Sex: Female, Male Female | 36 Participants | 82 Participants | 70 Participants | 188 Participants |
| Sex: Female, Male Male | 73 Participants | 145 Participants | 156 Participants | 374 Participants |
| Sex/Gender, Customized African American/African Heritage (HER) | 3 Participants | 13 Participants | 14 Participants | 30 Participants |
| Sex/Gender, Customized Japanese/East Asian HER/South East Asian HER | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized White | 104 Participants | 214 Participants | 211 Participants | 529 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 109 | 78 / 227 | 65 / 226 |
| serious Total, serious adverse events | 7 / 109 | 17 / 227 | 14 / 226 |
Outcome results
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.
Time frame: From the start of study drug up to 52 weeks
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment AE | 57 Participants |
| Placebo | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment SAE | 7 Participants |
| UMEC 125 µg | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment AE | 132 Participants |
| UMEC 125 µg | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment SAE | 17 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment AE | 120 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any on-treatment SAE | 14 Participants |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | CK, Month 9, n=69, 148, 149 | 3.8 International units per liter (IU/L) | Standard Deviation 55.89 |
| Placebo | 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 | ALP, Month 12, n=65, 129, 140 | -1.9 International units per liter (IU/L) | Standard Deviation 18.09 |
| Placebo | 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 | ALT, Month 3, n=88, 190, 193 | 0.3 International units per liter (IU/L) | Standard Deviation 12.53 |
| Placebo | 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 | CK, Month 6, n=73, 158, 172 | -8.3 International units per liter (IU/L) | Standard Deviation 41.87 |
| Placebo | 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 | AST, Month 3, n=88, 190, 192 | 0.1 International units per liter (IU/L) | Standard Deviation 19.27 |
| Placebo | 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 | ALT, Month 12, n=65, 129, 140 | -1.7 International units per liter (IU/L) | Standard Deviation 14.92 |
| Placebo | 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 | CK, Month 3, n=88, 190, 193 | 2.4 International units per liter (IU/L) | Standard Deviation 84.76 |
| Placebo | 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 | AST, Month 6, n=73, 158, 172 | -2.8 International units per liter (IU/L) | Standard Deviation 18.52 |
| Placebo | 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 | GGT, Month 12, n=65, 129, 140 | -6.9 International units per liter (IU/L) | Standard Deviation 44.77 |
| Placebo | 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 | AST, Month 12, n=65, 129, 140 | -0.6 International units per liter (IU/L) | Standard Deviation 12.06 |
| Placebo | 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 | AST, Month 9, n=69, 148, 148 | -1.1 International units per liter (IU/L) | Standard Deviation 10.79 |
| Placebo | 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 | GGT, Month 6, n=73, 158, 172 | -5.6 International units per liter (IU/L) | Standard Deviation 48.15 |
| Placebo | 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 | ALP, Month 3, n=88, 190, 193 | 1.1 International units per liter (IU/L) | Standard Deviation 21.9 |
| Placebo | 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 | GGT, Month 9, n=69, 148, 149 | -1.3 International units per liter (IU/L) | Standard Deviation 25.59 |
| Placebo | 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 | GGT, Month 3, n=88, 190, 193 | 11.5 International units per liter (IU/L) | Standard Deviation 95.98 |
| Placebo | 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 | ALP, Month 6, n=73, 158, 172 | -0.4 International units per liter (IU/L) | Standard Deviation 23.35 |
| Placebo | 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 | ALT, Month 9, n=69, 148, 149 | -0.6 International units per liter (IU/L) | Standard Deviation 12.81 |
| Placebo | 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 | CK, Month 12, n=64, 129, 140 | -1.8 International units per liter (IU/L) | Standard Deviation 46.31 |
| Placebo | 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 | ALP, Month 9, n=69, 148, 149 | -1.5 International units per liter (IU/L) | Standard Deviation 18.53 |
| Placebo | 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 | ALT, Month 6, n=73, 158, 172 | -1.3 International units per liter (IU/L) | Standard Deviation 14.03 |
| UMEC 125 µg | 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 | GGT, Month 6, n=73, 158, 172 | 9.8 International units per liter (IU/L) | Standard Deviation 73.28 |
| UMEC 125 µg | 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 | ALT, Month 3, n=88, 190, 193 | 0.8 International units per liter (IU/L) | Standard Deviation 9.4 |
| UMEC 125 µg | 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 | ALT, Month 6, n=73, 158, 172 | 3.2 International units per liter (IU/L) | Standard Deviation 22.35 |
| UMEC 125 µg | 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 | ALT, Month 9, n=69, 148, 149 | -0.2 International units per liter (IU/L) | Standard Deviation 7.64 |
| UMEC 125 µg | 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 | ALT, Month 12, n=65, 129, 140 | 1.3 International units per liter (IU/L) | Standard Deviation 15.63 |
| UMEC 125 µg | 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 | ALP, Month 3, n=88, 190, 193 | -1.6 International units per liter (IU/L) | Standard Deviation 12.13 |
| UMEC 125 µg | 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 | ALP, Month 6, n=73, 158, 172 | -1.6 International units per liter (IU/L) | Standard Deviation 17.15 |
| UMEC 125 µg | 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 | ALP, Month 9, n=69, 148, 149 | -2.2 International units per liter (IU/L) | Standard Deviation 12.68 |
| UMEC 125 µg | 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 | ALP, Month 12, n=65, 129, 140 | 4.3 International units per liter (IU/L) | Standard Deviation 61.45 |
| UMEC 125 µg | 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 | AST, Month 3, n=88, 190, 192 | 1.3 International units per liter (IU/L) | Standard Deviation 10.87 |
| UMEC 125 µg | 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 | AST, Month 6, n=73, 158, 172 | 3.8 International units per liter (IU/L) | Standard Deviation 23.71 |
| UMEC 125 µg | 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 | AST, Month 9, n=69, 148, 148 | 0.1 International units per liter (IU/L) | Standard Deviation 6.53 |
| UMEC 125 µg | 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 | AST, Month 12, n=65, 129, 140 | 2.6 International units per liter (IU/L) | Standard Deviation 15.71 |
| UMEC 125 µg | 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 | CK, Month 3, n=88, 190, 193 | -1.8 International units per liter (IU/L) | Standard Deviation 97.44 |
| UMEC 125 µg | 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 | CK, Month 6, n=73, 158, 172 | 3.6 International units per liter (IU/L) | Standard Deviation 114.53 |
| UMEC 125 µg | 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 | CK, Month 9, n=69, 148, 149 | -2.3 International units per liter (IU/L) | Standard Deviation 113.58 |
| UMEC 125 µg | 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 | CK, Month 12, n=64, 129, 140 | 0.9 International units per liter (IU/L) | Standard Deviation 118.66 |
| UMEC 125 µg | 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 | GGT, Month 3, n=88, 190, 193 | 1.0 International units per liter (IU/L) | Standard Deviation 24.07 |
| UMEC 125 µg | 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 | GGT, Month 9, n=69, 148, 149 | -0.5 International units per liter (IU/L) | Standard Deviation 22.45 |
| UMEC 125 µg | 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 | GGT, Month 12, n=65, 129, 140 | 7.8 International units per liter (IU/L) | Standard Deviation 72.04 |
| UMEC/VI 125/25 µg | 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 | ALT, Month 6, n=73, 158, 172 | 1.0 International units per liter (IU/L) | Standard Deviation 16.83 |
| UMEC/VI 125/25 µg | 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 | CK, Month 6, n=73, 158, 172 | 10.8 International units per liter (IU/L) | Standard Deviation 94.52 |
| UMEC/VI 125/25 µg | 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 | ALP, Month 9, n=69, 148, 149 | 0.0 International units per liter (IU/L) | Standard Deviation 16.51 |
| UMEC/VI 125/25 µg | 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 | GGT, Month 12, n=65, 129, 140 | -2.0 International units per liter (IU/L) | Standard Deviation 30.93 |
| UMEC/VI 125/25 µg | 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 | CK, Month 9, n=69, 148, 149 | 3.5 International units per liter (IU/L) | Standard Deviation 58.82 |
| UMEC/VI 125/25 µg | 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 | ALP, Month 6, n=73, 158, 172 | -0.9 International units per liter (IU/L) | Standard Deviation 14.44 |
| UMEC/VI 125/25 µg | 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 | GGT, Month 9, n=69, 148, 149 | -2.5 International units per liter (IU/L) | Standard Deviation 39.81 |
| UMEC/VI 125/25 µg | 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 | CK, Month 12, n=64, 129, 140 | 16.7 International units per liter (IU/L) | Standard Deviation 68.75 |
| UMEC/VI 125/25 µg | 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 | ALP, Month 3, n=88, 190, 193 | 0.3 International units per liter (IU/L) | Standard Deviation 12.91 |
| UMEC/VI 125/25 µg | 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 | ALT, Month 3, n=88, 190, 193 | 0.6 International units per liter (IU/L) | Standard Deviation 15.27 |
| UMEC/VI 125/25 µg | 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 | GGT, Month 3, n=88, 190, 193 | -2.1 International units per liter (IU/L) | Standard Deviation 53.42 |
| UMEC/VI 125/25 µg | 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 | ALT, Month 12, n=65, 129, 140 | -1.7 International units per liter (IU/L) | Standard Deviation 17.53 |
| UMEC/VI 125/25 µg | 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 | AST, Month 9, n=69, 148, 148 | -1.1 International units per liter (IU/L) | Standard Deviation 12.95 |
| UMEC/VI 125/25 µg | 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 | AST, Month 6, n=73, 158, 172 | 1.3 International units per liter (IU/L) | Standard Deviation 16.5 |
| UMEC/VI 125/25 µg | 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 | ALT, Month 9, n=69, 148, 149 | -0.5 International units per liter (IU/L) | Standard Deviation 14.68 |
| UMEC/VI 125/25 µg | 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 | AST, Month 12, n=65, 129, 140 | -0.8 International units per liter (IU/L) | Standard Deviation 12.01 |
| UMEC/VI 125/25 µg | 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 | AST, Month 3, n=88, 190, 192 | 1.0 International units per liter (IU/L) | Standard Deviation 14.75 |
| UMEC/VI 125/25 µg | 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 | GGT, Month 6, n=73, 158, 172 | 1.5 International units per liter (IU/L) | Standard Deviation 27.49 |
| UMEC/VI 125/25 µg | 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 | CK, Month 3, n=88, 190, 193 | 7.0 International units per liter (IU/L) | Standard Deviation 63.51 |
| UMEC/VI 125/25 µg | 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 | ALP, Month 12, n=65, 129, 140 | 0.2 International units per liter (IU/L) | Standard Deviation 15.93 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 3, n=88, 190, 193 | -0.5 Grams per liter (G/L) | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 6, n=73, 158, 172 | -0.6 Grams per liter (G/L) | Standard Deviation 2.89 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 9, n=69, 149, 149 | -0.1 Grams per liter (G/L) | Standard Deviation 3.19 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 12, n=65, 129, 140 | -1.2 Grams per liter (G/L) | Standard Deviation 3.27 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 3, n=88, 190, 193 | -1.2 Grams per liter (G/L) | Standard Deviation 3.99 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 6, n=73, 158, 172 | -1.1 Grams per liter (G/L) | Standard Deviation 4.01 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 9, n=69, 148, 149 | -0.7 Grams per liter (G/L) | Standard Deviation 4.5 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 12, n=65, 129, 140 | -2.1 Grams per liter (G/L) | Standard Deviation 4.48 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 3, n=94, 198, 206 | -1.2 Grams per liter (G/L) | Standard Deviation 8.51 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 6, n=75, 159, 171 | -1.6 Grams per liter (G/L) | Standard Deviation 9.85 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 9, n=70, 152, 155 | -1.4 Grams per liter (G/L) | Standard Deviation 11.95 |
| Placebo | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 12, n=63, 130, 143 | -2.7 Grams per liter (G/L) | Standard Deviation 11.36 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 12, n=63, 130, 143 | -2.5 Grams per liter (G/L) | Standard Deviation 7.04 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 3, n=88, 190, 193 | -0.8 Grams per liter (G/L) | Standard Deviation 2.48 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 9, n=69, 148, 149 | -1.8 Grams per liter (G/L) | Standard Deviation 3.52 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 3, n=94, 198, 206 | -1.5 Grams per liter (G/L) | Standard Deviation 8.05 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 6, n=73, 158, 172 | -0.9 Grams per liter (G/L) | Standard Deviation 2.59 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 6, n=73, 158, 172 | -1.8 Grams per liter (G/L) | Standard Deviation 3.57 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 9, n=70, 152, 155 | -2.5 Grams per liter (G/L) | Standard Deviation 10.35 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 9, n=69, 149, 149 | -0.8 Grams per liter (G/L) | Standard Deviation 2.55 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 12, n=65, 129, 140 | -2.6 Grams per liter (G/L) | Standard Deviation 3.48 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 3, n=88, 190, 193 | -1.3 Grams per liter (G/L) | Standard Deviation 3.52 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 12, n=65, 129, 140 | -1.4 Grams per liter (G/L) | Standard Deviation 2.35 |
| UMEC 125 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 6, n=75, 159, 171 | -1.2 Grams per liter (G/L) | Standard Deviation 7.31 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 12, n=65, 129, 140 | -0.9 Grams per liter (G/L) | Standard Deviation 3 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 3, n=88, 190, 193 | -1.1 Grams per liter (G/L) | Standard Deviation 3.91 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 6, n=75, 159, 171 | -1.4 Grams per liter (G/L) | Standard Deviation 9.31 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 6, n=73, 158, 172 | -0.7 Grams per liter (G/L) | Standard Deviation 4.1 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 9, n=69, 148, 149 | -1.4 Grams per liter (G/L) | Standard Deviation 4.56 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Total protein, Month 12, n=65, 129, 140 | -1.9 Grams per liter (G/L) | Standard Deviation 3.82 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 9, n=70, 152, 155 | -2.2 Grams per liter (G/L) | Standard Deviation 8.78 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 3, n=88, 190, 193 | -0.8 Grams per liter (G/L) | Standard Deviation 2.67 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 6, n=73, 158, 172 | -0.4 Grams per liter (G/L) | Standard Deviation 2.85 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 3, n=94, 198, 206 | -2.0 Grams per liter (G/L) | Standard Deviation 8.34 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Albumin, Month 9, n=69, 149, 149 | -0.5 Grams per liter (G/L) | Standard Deviation 3.31 |
| UMEC/VI 125/25 µg | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12 | Hemoglobin, Month 12, n=63, 130, 143 | -2.1 Grams per liter (G/L) | Standard Deviation 9.19 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Potassium, Month 12, n=65, 129, 140 | -0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.489 |
| Placebo | 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 | Potassium, Month 3, n=88, 190, 192 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.464 |
| Placebo | 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 | Glucose, Month 3, n=88, 190, 193 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 1.269 |
| Placebo | 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 | Chloride, Month 12, n=64, 129, 140 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.08 |
| Placebo | 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 | Potassium, Month 9, n=69, 149, 148 | -0.14 Millimoles per liter (mmol/L) | Standard Deviation 0.461 |
| Placebo | 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 | Glucose, Month 6, n=73, 158, 172 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.412 |
| Placebo | 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 | Calcium, Month 9, n=69, 147, 148 | -0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.1009 |
| Placebo | 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 | IP, Month 12, n=64, 129, 140 | -0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.1838 |
| Placebo | 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 | Glucose, Month 9, n=69, 149, 149 | 0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.333 |
| Placebo | 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 | Sodium, Month 9, n=69, 149, 149 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| Placebo | 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 | IP, Month 9, n=68, 147, 149 | -0.026 Millimoles per liter (mmol/L) | Standard Deviation 0.1773 |
| Placebo | 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 | Glucose, Month 12, n=65, 129, 140 | 0.19 Millimoles per liter (mmol/L) | Standard Deviation 1.08 |
| Placebo | 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 | Potassium, Month 6, n=73, 158, 171 | -0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.462 |
| Placebo | 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 | IP, Month 6, n=72, 157, 171 | 0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.188 |
| Placebo | 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 | IP, Month 3, n=87, 189, 193 | 0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.1844 |
| Placebo | 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 | Calcium, Month 12, n=65, 129, 140 | -0.023 Millimoles per liter (mmol/L) | Standard Deviation 0.107 |
| Placebo | 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 | Chloride, Month 9, n=69, 149, 149 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.27 |
| Placebo | 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 | Urea/BUN, Month 9, n=69, 149, 149 | -0.12 Millimoles per liter (mmol/L) | Standard Deviation 1.981 |
| Placebo | 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 | CO2 content/bicarbonate, Month 3, n=88, 190, 192 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.99 |
| Placebo | 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 | Calcium, Month 3, n=88, 189, 192 | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.0957 |
| Placebo | 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 | Urea/BUN, Month 6, n=73, 158, 172 | -0.06 Millimoles per liter (mmol/L) | Standard Deviation 2.734 |
| Placebo | 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 | CO2 content/bicarbonate, Month 6, n=73, 158, 172 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 3.03 |
| Placebo | 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 | Chloride, Month 6, n=73, 158, 172 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| Placebo | 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 | Urea/BUN, Month 3, n=88, 190, 193 | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 1.961 |
| Placebo | 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 | CO2 content/bicarbonate, Month 9, n=69, 149, 148 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 3.21 |
| Placebo | 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 | Sodium, Month 6, n=73, 158, 172 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Placebo | 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 | Sodium, Month 12, n=64, 129, 140 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| Placebo | 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 | CO2 content/bicarbonate, Month 12, n=65, 129, 140 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 3.06 |
| Placebo | 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 | Calcium, Month 6, n=73, 157, 172 | -0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.0893 |
| Placebo | 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 | Sodium, Month 3, n=88, 190, 193 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| Placebo | 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 | Chloride, Month 3, n=88, 190, 193 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 3.03 |
| Placebo | 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 | Urea/BUN, Month 12, n=65, 129, 140 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 2.591 |
| UMEC 125 µg | 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 | Potassium, Month 12, n=65, 129, 140 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.473 |
| UMEC 125 µg | 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 | Chloride, Month 6, n=73, 158, 172 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.9 |
| UMEC 125 µg | 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 | Calcium, Month 3, n=88, 189, 192 | -0.006 Millimoles per liter (mmol/L) | Standard Deviation 0.1178 |
| UMEC 125 µg | 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 | Calcium, Month 6, n=73, 157, 172 | -0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.1058 |
| UMEC 125 µg | 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 | Calcium, Month 9, n=69, 147, 148 | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.1036 |
| UMEC 125 µg | 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 | Calcium, Month 12, n=65, 129, 140 | -0.007 Millimoles per liter (mmol/L) | Standard Deviation 0.0959 |
| UMEC 125 µg | 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 | CO2 content/bicarbonate, Month 3, n=88, 190, 192 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.7 |
| UMEC 125 µg | 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 | CO2 content/bicarbonate, Month 6, n=73, 158, 172 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.84 |
| UMEC 125 µg | 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 | CO2 content/bicarbonate, Month 9, n=69, 149, 148 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.78 |
| UMEC 125 µg | 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 | CO2 content/bicarbonate, Month 12, n=65, 129, 140 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.7 |
| UMEC 125 µg | 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 | Chloride, Month 3, n=88, 190, 193 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.33 |
| UMEC 125 µg | 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 | Glucose, Month 3, n=88, 190, 193 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 1.315 |
| UMEC 125 µg | 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 | Glucose, Month 6, n=73, 158, 172 | 0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.645 |
| UMEC 125 µg | 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 | Glucose, Month 9, n=69, 149, 149 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 1.959 |
| UMEC 125 µg | 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 | Glucose, Month 12, n=65, 129, 140 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 1.741 |
| UMEC 125 µg | 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 | IP, Month 3, n=87, 189, 193 | 0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.1663 |
| UMEC 125 µg | 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 | IP, Month 6, n=72, 157, 171 | 0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.1686 |
| UMEC 125 µg | 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 | IP, Month 9, n=68, 147, 149 | -0.002 Millimoles per liter (mmol/L) | Standard Deviation 0.185 |
| UMEC 125 µg | 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 | IP, Month 12, n=64, 129, 140 | 0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.1821 |
| UMEC 125 µg | 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 | Potassium, Month 9, n=69, 149, 148 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.494 |
| UMEC 125 µg | 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 | Sodium, Month 12, n=64, 129, 140 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.4 |
| UMEC 125 µg | 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 | Urea/BUN, Month 3, n=88, 190, 193 | -0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.574 |
| UMEC 125 µg | 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 | Urea/BUN, Month 9, n=69, 149, 149 | -0.21 Millimoles per liter (mmol/L) | Standard Deviation 1.692 |
| UMEC 125 µg | 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 | Potassium, Month 3, n=88, 190, 192 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.49 |
| UMEC 125 µg | 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 | Potassium, Month 6, n=73, 158, 171 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.468 |
| UMEC 125 µg | 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 | Urea/BUN, Month 6, n=73, 158, 172 | -0.12 Millimoles per liter (mmol/L) | Standard Deviation 1.698 |
| UMEC 125 µg | 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 | Chloride, Month 9, n=69, 149, 149 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.93 |
| UMEC 125 µg | 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 | Chloride, Month 12, n=64, 129, 140 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.56 |
| UMEC 125 µg | 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 | Urea/BUN, Month 12, n=65, 129, 140 | -0.29 Millimoles per liter (mmol/L) | Standard Deviation 1.631 |
| UMEC 125 µg | 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 | Sodium, Month 3, n=88, 190, 193 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| UMEC 125 µg | 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 | Sodium, Month 6, n=73, 158, 172 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.63 |
| UMEC 125 µg | 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 | Sodium, Month 9, n=69, 149, 149 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.72 |
| UMEC/VI 125/25 µg | 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 | CO2 content/bicarbonate, Month 9, n=69, 149, 148 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| UMEC/VI 125/25 µg | 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 | Potassium, Month 12, n=65, 129, 140 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.51 |
| UMEC/VI 125/25 µg | 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 | Sodium, Month 12, n=64, 129, 140 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.75 |
| UMEC/VI 125/25 µg | 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 | CO2 content/bicarbonate, Month 6, n=73, 158, 172 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.14 |
| UMEC/VI 125/25 µg | 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 | Urea/BUN, Month 9, n=69, 149, 149 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.696 |
| UMEC/VI 125/25 µg | 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 | Urea/BUN, Month 6, n=73, 158, 172 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 1.875 |
| UMEC/VI 125/25 µg | 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 | Urea/BUN, Month 3, n=88, 190, 193 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 1.814 |
| UMEC/VI 125/25 µg | 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 | CO2 content/bicarbonate, Month 3, n=88, 190, 192 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| UMEC/VI 125/25 µg | 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 | Calcium, Month 12, n=65, 129, 140 | -0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.1059 |
| UMEC/VI 125/25 µg | 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 | Sodium, Month 3, n=88, 190, 193 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| UMEC/VI 125/25 µg | 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 | Calcium, Month 3, n=88, 189, 192 | -0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.099 |
| UMEC/VI 125/25 µg | 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 | Potassium, Month 3, n=88, 190, 192 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 0.474 |
| UMEC/VI 125/25 µg | 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 | Calcium, Month 9, n=69, 147, 148 | -0.014 Millimoles per liter (mmol/L) | Standard Deviation 0.1023 |
| UMEC/VI 125/25 µg | 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 | Chloride, Month 3, n=88, 190, 193 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.6 |
| UMEC/VI 125/25 µg | 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 | Sodium, Month 6, n=73, 158, 172 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.48 |
| UMEC/VI 125/25 µg | 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 | Chloride, Month 6, n=73, 158, 172 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 3.23 |
| UMEC/VI 125/25 µg | 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 | IP, Month 3, n=87, 189, 193 | -0.018 Millimoles per liter (mmol/L) | Standard Deviation 0.1886 |
| UMEC/VI 125/25 µg | 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 | Glucose, Month 12, n=65, 129, 140 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 2.453 |
| UMEC/VI 125/25 µg | 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 | Chloride, Month 9, n=69, 149, 149 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.94 |
| UMEC/VI 125/25 µg | 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 | IP, Month 6, n=72, 157, 171 | 0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.2125 |
| UMEC/VI 125/25 µg | 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 | Glucose, Month 9, n=69, 149, 149 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 2.309 |
| UMEC/VI 125/25 µg | 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 | Calcium, Month 6, n=73, 157, 172 | 0.000 Millimoles per liter (mmol/L) | Standard Deviation 0.1104 |
| UMEC/VI 125/25 µg | 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 | IP, Month 9, n=68, 147, 149 | 0.005 Millimoles per liter (mmol/L) | Standard Deviation 0.1962 |
| UMEC/VI 125/25 µg | 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 | Glucose, Month 6, n=73, 158, 172 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 2.507 |
| UMEC/VI 125/25 µg | 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 | Urea/BUN, Month 12, n=65, 129, 140 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 1.613 |
| UMEC/VI 125/25 µg | 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 | IP, Month 12, n=64, 129, 140 | 0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.1793 |
| UMEC/VI 125/25 µg | 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 | Glucose, Month 3, n=88, 190, 193 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 1.419 |
| UMEC/VI 125/25 µg | 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 | Chloride, Month 12, n=64, 129, 140 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.86 |
| UMEC/VI 125/25 µg | 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 | Sodium, Month 9, n=69, 149, 149 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| UMEC/VI 125/25 µg | 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 | Potassium, Month 9, n=69, 149, 148 | -0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.498 |
| UMEC/VI 125/25 µg | 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 | Potassium, Month 6, n=73, 158, 171 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 0.428 |
| UMEC/VI 125/25 µg | 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 | CO2 content/bicarbonate, Month 12, n=65, 129, 140 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.49 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 12, n=65, 129, 140 | -0.06 Micromoles per liter (µmol/L) | Standard Deviation 20.259 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 12, n=65, 129, 140 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.06 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 3, n=88, 190, 192 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.3 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 6, n=73, 158, 171 | -0.52 Micromoles per liter (µmol/L) | Standard Deviation 19.828 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 9, n=69, 148, 149 | 0.2 Micromoles per liter (µmol/L) | Standard Deviation 4.13 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 6, n=73, 158, 172 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.21 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 9, n=69, 147, 149 | -2.9 Micromoles per liter (µmol/L) | Standard Deviation 72.4 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 6, n=73, 158, 172 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.61 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 9, n=69, 148, 149 | 0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.68 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 3, n=88, 190, 192 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 3, n=88, 190, 193 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.76 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 12, n=65, 129, 139 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 2.74 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 9, n=69, 148, 149 | -1.17 Micromoles per liter (µmol/L) | Standard Deviation 20.543 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 6, n=73, 157, 172 | 2.5 Micromoles per liter (µmol/L) | Standard Deviation 85.86 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct Bilirubin, Month 6, n=73, 158, 172 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 12, n=65, 129, 140 | 11.4 Micromoles per liter (µmol/L) | Standard Deviation 80.09 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 3, n=88, 189, 193 | -3.4 Micromoles per liter (µmol/L) | Standard Deviation 68.15 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 9, n=69, 149, 149 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 3, n=88, 190, 193 | -3.20 Micromoles per liter (µmol/L) | Standard Deviation 16.221 |
| Placebo | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 12, n=65, 129, 139 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.88 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 9, n=69, 147, 149 | -8.3 Micromoles per liter (µmol/L) | Standard Deviation 61.57 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 3, n=88, 189, 193 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 53.93 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 12, n=65, 129, 140 | -2.8 Micromoles per liter (µmol/L) | Standard Deviation 65.58 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 9, n=69, 148, 149 | -0.71 Micromoles per liter (µmol/L) | Standard Deviation 9.78 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 12, n=65, 129, 140 | 1.11 Micromoles per liter (µmol/L) | Standard Deviation 12.375 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 3, n=88, 190, 192 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.13 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct Bilirubin, Month 6, n=73, 158, 172 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.2 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 9, n=69, 149, 149 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.98 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 12, n=65, 129, 139 | 0.8 Micromoles per liter (µmol/L) | Standard Deviation 8.77 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 3, n=88, 190, 192 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.64 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 6, n=73, 158, 172 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 3.69 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 9, n=69, 148, 149 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 3.28 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 12, n=65, 129, 139 | 0.4 Micromoles per liter (µmol/L) | Standard Deviation 8.6 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 3, n=88, 190, 193 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 4.29 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 6, n=73, 158, 172 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 4.37 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 9, n=69, 148, 149 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 3.82 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 12, n=65, 129, 140 | 1.2 Micromoles per liter (µmol/L) | Standard Deviation 17.09 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 6, n=73, 157, 172 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 57.74 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 6, n=73, 158, 171 | -1.14 Micromoles per liter (µmol/L) | Standard Deviation 9.047 |
| UMEC 125 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 3, n=88, 190, 193 | -1.63 Micromoles per liter (µmol/L) | Standard Deviation 9.119 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 3, n=88, 190, 192 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.03 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 6, n=73, 158, 171 | 0.13 Micromoles per liter (µmol/L) | Standard Deviation 11.418 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 9, n=69, 148, 149 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 3.41 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 12, n=65, 129, 139 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.12 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 9, n=69, 148, 149 | 0.26 Micromoles per liter (µmol/L) | Standard Deviation 11.057 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 12, n=65, 129, 140 | -0.7 Micromoles per liter (µmol/L) | Standard Deviation 4.25 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct Bilirubin, Month 6, n=73, 158, 172 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.91 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 3, n=88, 189, 193 | 16.2 Micromoles per liter (µmol/L) | Standard Deviation 72.11 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 3, n=88, 190, 192 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.05 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 12, n=65, 129, 140 | 0.9 Micromoles per liter (µmol/L) | Standard Deviation 69.74 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 6, n=73, 157, 172 | 1.9 Micromoles per liter (µmol/L) | Standard Deviation 63.17 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 12, n=65, 129, 140 | 1.79 Micromoles per liter (µmol/L) | Standard Deviation 11.571 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Direct bilirubin, Month 9, n=69, 149, 149 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.93 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 12, n=65, 129, 139 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 3.51 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 9, n=69, 148, 149 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 2.93 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Uric acid, Month 9, n=69, 147, 149 | -1.9 Micromoles per liter (µmol/L) | Standard Deviation 66.69 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 3, n=88, 190, 193 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.52 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Indirect bilirubin, Month 6, n=73, 158, 172 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 2.94 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Creatinine, Month 3, n=88, 190, 193 | -0.51 Micromoles per liter (µmol/L) | Standard Deviation 10.034 |
| UMEC/VI 125/25 µg | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12 | Total bilirubin, Month 6, n=73, 158, 172 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 3.51 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 9, n=70, 152, 154 | 0.003 10^9 cells per liter (GI/L) | Standard Deviation 0.1613 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 6, n=73, 156, 167 | -0.06 10^9 cells per liter (GI/L) | Standard Deviation 1.666 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 6, n=73, 155, 169 | -11.6 10^9 cells per liter (GI/L) | Standard Deviation 39.11 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 3, n=93, 198, 206 | 0.001 10^9 cells per liter (GI/L) | Standard Deviation 0.1134 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 3, n=93, 198, 206 | -0.20 10^9 cells per liter (GI/L) | Standard Deviation 1.575 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 9, n=68, 151, 154 | -9.5 10^9 cells per liter (GI/L) | Standard Deviation 39.36 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 9, n=70, 152, 154 | 0.29 10^9 cells per liter (GI/L) | Standard Deviation 2.82 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 12, n=61, 128, 140 | -11.8 10^9 cells per liter (GI/L) | Standard Deviation 34.45 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 12, n=62, 130, 141 | -0.003 10^9 cells per liter (GI/L) | Standard Deviation 0.1297 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 12, n=62, 130, 141 | -0.19 10^9 cells per liter (GI/L) | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 6, n=73, 156, 167 | -0.005 10^9 cells per liter (GI/L) | Standard Deviation 0.1246 |
| Placebo | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 3, n=93, 197, 204 | 2.2 10^9 cells per liter (GI/L) | Standard Deviation 40.22 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 12, n=62, 130, 141 | -0.21 10^9 cells per liter (GI/L) | Standard Deviation 2.114 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 3, n=93, 198, 206 | -0.002 10^9 cells per liter (GI/L) | Standard Deviation 0.1497 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 6, n=73, 156, 167 | -0.007 10^9 cells per liter (GI/L) | Standard Deviation 0.1277 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 9, n=70, 152, 154 | -0.023 10^9 cells per liter (GI/L) | Standard Deviation 0.1445 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 12, n=62, 130, 141 | -0.013 10^9 cells per liter (GI/L) | Standard Deviation 0.1678 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 3, n=93, 197, 204 | -4.4 10^9 cells per liter (GI/L) | Standard Deviation 38.28 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 6, n=73, 155, 169 | -5.4 10^9 cells per liter (GI/L) | Standard Deviation 39.61 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 9, n=68, 151, 154 | -3.0 10^9 cells per liter (GI/L) | Standard Deviation 39.85 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 12, n=61, 128, 140 | -4.4 10^9 cells per liter (GI/L) | Standard Deviation 33.09 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 3, n=93, 198, 206 | -0.27 10^9 cells per liter (GI/L) | Standard Deviation 1.781 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 6, n=73, 156, 167 | -0.13 10^9 cells per liter (GI/L) | Standard Deviation 1.663 |
| UMEC 125 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 9, n=70, 152, 154 | -0.09 10^9 cells per liter (GI/L) | Standard Deviation 1.919 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 9, n=70, 152, 154 | -0.19 10^9 cells per liter (GI/L) | Standard Deviation 1.85 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 3, n=93, 198, 206 | -0.21 10^9 cells per liter (GI/L) | Standard Deviation 1.797 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 3, n=93, 197, 204 | 4.4 10^9 cells per liter (GI/L) | Standard Deviation 34.39 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 6, n=73, 156, 167 | 0.015 10^9 cells per liter (GI/L) | Standard Deviation 0.1324 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 6, n=73, 156, 167 | -0.23 10^9 cells per liter (GI/L) | Standard Deviation 2.065 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | WBC count, Month 12, n=62, 130, 141 | -0.09 10^9 cells per liter (GI/L) | Standard Deviation 1.871 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 12, n=62, 130, 141 | 0.010 10^9 cells per liter (GI/L) | Standard Deviation 0.1496 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 9, n=70, 152, 154 | 0.001 10^9 cells per liter (GI/L) | Standard Deviation 0.1227 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 9, n=68, 151, 154 | 0.7 10^9 cells per liter (GI/L) | Standard Deviation 37.24 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Eosinophil count, Month 3, n=93, 198, 206 | -0.007 10^9 cells per liter (GI/L) | Standard Deviation 0.1292 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 12, n=61, 128, 140 | 4.4 10^9 cells per liter (GI/L) | Standard Deviation 37.68 |
| UMEC/VI 125/25 µg | Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12 | Platelet count, Month 6, n=73, 155, 169 | -0.6 10^9 cells per liter (GI/L) | Standard Deviation 33.65 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 3, n=94, 198, 206 | -0.0140 Proportion of red blood cells in blood | Standard Deviation 0.02757 |
| Placebo | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 6, n=75, 159, 171 | -0.0195 Proportion of red blood cells in blood | Standard Deviation 0.0332 |
| Placebo | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 9, n=70, 152, 155 | -0.0133 Proportion of red blood cells in blood | Standard Deviation 0.03785 |
| Placebo | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 12, n=63, 130, 143 | -0.0072 Proportion of red blood cells in blood | Standard Deviation 0.03336 |
| UMEC 125 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 12, n=63, 130, 143 | -0.0045 Proportion of red blood cells in blood | Standard Deviation 0.02356 |
| UMEC 125 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 3, n=94, 198, 206 | -0.0134 Proportion of red blood cells in blood | Standard Deviation 0.02656 |
| UMEC 125 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 9, n=70, 152, 155 | -0.0139 Proportion of red blood cells in blood | Standard Deviation 0.03158 |
| UMEC 125 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 6, n=75, 159, 171 | -0.0177 Proportion of red blood cells in blood | Standard Deviation 0.02446 |
| UMEC/VI 125/25 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 12, n=63, 130, 143 | -0.0040 Proportion of red blood cells in blood | Standard Deviation 0.2959 |
| UMEC/VI 125/25 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 6, n=75, 159, 171 | -0.0170 Proportion of red blood cells in blood | Standard Deviation 0.02871 |
| UMEC/VI 125/25 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 9, n=70, 152, 155 | -0.0146 Proportion of red blood cells in blood | Standard Deviation 0.02829 |
| UMEC/VI 125/25 µg | Change From Baseline in Hematocrit at Months 3, 6, 9, and 12 | Month 3, n=94, 198, 206 | -0.0131 Proportion of red blood cells in blood | Standard Deviation 0.02699 |
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.
Time frame: Baseline; from the start of study drug up to 52 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | -0.4 Number of puffs per day | Standard Error 0.2 |
| UMEC 125 µg | 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 | -0.8 Number of puffs per day | Standard Error 0.14 |
| UMEC/VI 125/25 µg | 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 | -1.4 Number of puffs per day | Standard Error 0.13 |
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.
Time frame: Baseline; Months 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 6, n=73, 156, 167 | 0.53 Percentage in blood | Standard Deviation 9.264 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 12, n=62, 130, 141 | -0.05 Percentage in blood | Standard Deviation 0.235 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 9, n=70, 152, 154 | -0.01 Percentage in blood | Standard Deviation 0.265 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 12, n=62, 130, 141 | -0.93 Percentage in blood | Standard Deviation 6.654 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 6, n=73, 156, 167 | 0.04 Percentage in blood | Standard Deviation 1.72 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 9, n=70, 152, 154 | 0.14 Percentage in blood | Standard Deviation 2.959 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 3, n=93, 198, 206 | -1.02 Percentage in blood | Standard Deviation 8.031 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 6, n=73, 156, 167 | 0.60 Percentage in blood | Standard Deviation 2.929 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 6, n=73, 156, 167 | -1.14 Percentage in blood | Standard Deviation 7.178 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 9, n=70, 152, 154 | 2.02 Percentage in blood | Standard Deviation 8.225 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 3, n=93, 198, 206 | -0.02 Percentage in blood | Standard Deviation 2.544 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 3, n=93, 198, 206 | 0.88 Percentage in blood | Standard Deviation 9.494 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 12, n=62, 130, 141 | 0.10 Percentage in blood | Standard Deviation 1.698 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 12, n=62, 130, 141 | 0.63 Percentage in blood | Standard Deviation 7.903 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 12, n=62, 130, 141 | 0.26 Percentage in blood | Standard Deviation 2.563 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 9, n=70, 152, 154 | 0.18 Percentage in blood | Standard Deviation 2.271 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 3, n=93, 198, 206 | -0.02 Percentage in blood | Standard Deviation 0.244 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 9, n=70, 152, 154 | -2.63 Percentage in blood | Standard Deviation 6.977 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 3, n=93, 198, 206 | 0.17 Percentage in blood | Standard Deviation 1.569 |
| Placebo | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 6, n=73, 156, 167 | -0.03 Percentage in blood | Standard Deviation 0.27 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 12, n=62, 130, 141 | -0.55 Percentage in blood | Standard Deviation 7.459 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 12, n=62, 130, 141 | 0.47 Percentage in blood | Standard Deviation 2.632 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 3, n=93, 198, 206 | 1.92 Percentage in blood | Standard Deviation 9.714 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 6, n=73, 156, 167 | -0.72 Percentage in blood | Standard Deviation 12.744 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 9, n=70, 152, 154 | 1.00 Percentage in blood | Standard Deviation 10.311 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 12, n=62, 130, 141 | 0.27 Percentage in blood | Standard Deviation 10.026 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 3, n=93, 198, 206 | 0.01 Percentage in blood | Standard Deviation 0.29 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 6, n=73, 156, 167 | 0.03 Percentage in blood | Standard Deviation 0.312 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 9, n=70, 152, 154 | 0.02 Percentage in blood | Standard Deviation 0.276 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 9, n=70, 152, 154 | -0.33 Percentage in blood | Standard Deviation 2.232 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 6, n=73, 156, 167 | -0.33 Percentage in blood | Standard Deviation 10.319 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 3, n=93, 198, 206 | -0.06 Percentage in blood | Standard Deviation 2.303 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 6, n=73, 156, 167 | 1.09 Percentage in blood | Standard Deviation 3.17 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 12, n=62, 130, 141 | 0.00 Percentage in blood | Standard Deviation 0.24 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 3, n=93, 198, 206 | -0.01 Percentage in blood | Standard Deviation 2.243 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 6, n=73, 156, 167 | -0.08 Percentage in blood | Standard Deviation 2.101 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 12, n=62, 130, 141 | -0.19 Percentage in blood | Standard Deviation 2.557 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 3, n=93, 198, 206 | -1.86 Percentage in blood | Standard Deviation 7.912 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 9, n=70, 152, 154 | 0.62 Percentage in blood | Standard Deviation 2.453 |
| UMEC 125 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 9, n=70, 152, 154 | -1.32 Percentage in blood | Standard Deviation 8.439 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 3, n=93, 198, 206 | 0.02 Percentage in blood | Standard Deviation 0.302 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 6, n=73, 156, 167 | 0.81 Percentage in blood | Standard Deviation 9.211 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 3, n=93, 198, 206 | -0.05 Percentage in blood | Standard Deviation 1.791 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 3, n=93, 198, 206 | 0.81 Percentage in blood | Standard Deviation 9.002 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 6, n=73, 156, 167 | 0.27 Percentage in blood | Standard Deviation 1.962 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 12, n=62, 130, 141 | 0.29 Percentage in blood | Standard Deviation 8.456 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 9, n=70, 152, 154 | 0.02 Percentage in blood | Standard Deviation 1.678 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 9, n=70, 152, 154 | 1.07 Percentage in blood | Standard Deviation 9.472 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 9, n=70, 152, 154 | 0.24 Percentage in blood | Standard Deviation 2.466 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Eosinophils, Month 12, n=62, 130, 141 | 0.09 Percentage in blood | Standard Deviation 2.021 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 9, n=70, 152, 154 | -1.35 Percentage in blood | Standard Deviation 8.265 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 12, n=62, 130, 141 | -0.25 Percentage in blood | Standard Deviation 7.138 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 12, n=62, 130, 141 | -0.16 Percentage in blood | Standard Deviation 2.198 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 3, n=93, 198, 206 | 0.13 Percentage in blood | Standard Deviation 2.296 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Lymphocytes, Month 3, n=93, 198, 206 | -0.92 Percentage in blood | Standard Deviation 7.474 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Monocytes, Month 6, n=73, 156, 167 | 0.56 Percentage in blood | Standard Deviation 2.935 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 9, n=70, 152, 154 | 0.02 Percentage in blood | Standard Deviation 0.3 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 6, n=73, 156, 167 | 0.01 Percentage in blood | Standard Deviation 0.314 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Segmented neutrophils, Month 6, n=73, 156, 167 | -1.65 Percentage in blood | Standard Deviation 11.543 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12 | Basophils, Month 12, n=62, 130, 141 | 0.02 Percentage in blood | Standard Deviation 0.266 |
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.
Time frame: From the start of study drug up to 52 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | 11.1 Percentage of rescue-free days | Standard Deviation 30.06 |
| UMEC 125 µg | Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | 13.1 Percentage of rescue-free days | Standard Deviation 37.35 |
| UMEC/VI 125/25 µg | Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period | 23.2 Percentage of rescue-free days | Standard Deviation 39.27 |
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.
Time frame: Baseline; Months 1, 3, 6, 9, and 12
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | FVC: Month 1, n=103, 215, 215 | -0.035 Liters | Standard Error 0.0386 |
| Placebo | 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 | FVC: Month 6, n=79, 163, 178 | -0.002 Liters | Standard Error 0.0478 |
| Placebo | 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: Month 3, n=90, 197, 208 | -0.036 Liters | Standard Error 0.0289 |
| Placebo | 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 | FVC: Month 3, n=90, 197, 208 | -0.044 Liters | Standard Error 0.0442 |
| Placebo | 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: Month 12, n=66, 132, 143 | -0.045 Liters | Standard Error 0.0332 |
| Placebo | 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: Month 1, n=103, 215, 215 | -0.030 Liters | Standard Error 0.0253 |
| Placebo | 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 | FVC: Month 9, n=71, 142, 153 | -0.076 Liters | Standard Error 0.051 |
| Placebo | 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: Month 9, n=71, 142, 153 | -0.050 Liters | Standard Error 0.0314 |
| Placebo | 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 | FVC: Month 12, n=66, 132, 143 | -0.039 Liters | Standard Error 0.0491 |
| Placebo | 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: Month 6, n=79, 163, 178 | -0.015 Liters | Standard Error 0.032 |
| UMEC 125 µg | 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: Month 1, n=103, 215, 215 | 0.138 Liters | Standard Error 0.0175 |
| UMEC 125 µg | 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: Month 3, n=90, 197, 208 | 0.140 Liters | Standard Error 0.0197 |
| UMEC 125 µg | 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: Month 6, n=79, 163, 178 | 0.144 Liters | Standard Error 0.0221 |
| UMEC 125 µg | 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: Month 9, n=71, 142, 153 | 0.104 Liters | Standard Error 0.0219 |
| UMEC 125 µg | 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: Month 12, n=66, 132, 143 | 0.133 Liters | Standard Error 0.0232 |
| UMEC 125 µg | 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 | FVC: Month 1, n=103, 215, 215 | 0.197 Liters | Standard Error 0.0267 |
| UMEC 125 µg | 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 | FVC: Month 3, n=90, 197, 208 | 0.189 Liters | Standard Error 0.0301 |
| UMEC 125 µg | 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 | FVC: Month 6, n=79, 163, 178 | 0.206 Liters | Standard Error 0.033 |
| UMEC 125 µg | 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 | FVC: Month 9, n=71, 142, 153 | 0.088 Liters | Standard Error 0.0356 |
| UMEC 125 µg | 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 | FVC: Month 12, n=66, 132, 143 | 0.155 Liters | Standard Error 0.0343 |
| UMEC/VI 125/25 µg | 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: Month 6, n=79, 163, 178 | 0.181 Liters | Standard Error 0.0214 |
| UMEC/VI 125/25 µg | 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 | FVC: Month 12, n=66, 132, 143 | 0.213 Liters | Standard Error 0.0333 |
| UMEC/VI 125/25 µg | 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 | FVC: Month 6, n=79, 163, 178 | 0.237 Liters | Standard Error 0.032 |
| UMEC/VI 125/25 µg | 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: Month 1, n=103, 215, 215 | 0.161 Liters | Standard Error 0.0174 |
| UMEC/VI 125/25 µg | 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 | FVC: Month 1, n=103, 215, 215 | 0.237 Liters | Standard Error 0.0267 |
| UMEC/VI 125/25 µg | 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: Month 3, n=90, 197, 208 | 0.189 Liters | Standard Error 0.0192 |
| UMEC/VI 125/25 µg | 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: Month 12, n=66, 132, 143 | 0.186 Liters | Standard Error 0.0224 |
| UMEC/VI 125/25 µg | 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: Month 9, n=71, 142, 153 | 0.180 Liters | Standard Error 0.0213 |
| UMEC/VI 125/25 µg | 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 | FVC: Month 3, n=90, 197, 208 | 0.244 Liters | Standard Error 0.0295 |
| UMEC/VI 125/25 µg | 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 | FVC: Month 9, n=71, 142, 153 | 0.200 Liters | Standard Error 0.0345 |
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.
Time frame: Baseline; from the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Change from Baseline to maximum SBP | 14.5 Millimeters of mercury (mmHg) | Standard Deviation 15.28 |
| Placebo | 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 | Change from Baseline to minimum DBP | -11.0 Millimeters of mercury (mmHg) | Standard Deviation 8.87 |
| UMEC 125 µg | 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 | Change from Baseline to maximum SBP | 14.0 Millimeters of mercury (mmHg) | Standard Deviation 14.05 |
| UMEC 125 µg | 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 | Change from Baseline to minimum DBP | -9.5 Millimeters of mercury (mmHg) | Standard Deviation 7.86 |
| UMEC/VI 125/25 µg | 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 | Change from Baseline to maximum SBP | 13.5 Millimeters of mercury (mmHg) | Standard Deviation 13.02 |
| UMEC/VI 125/25 µg | 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 | Change from Baseline to minimum DBP | -10.8 Millimeters of mercury (mmHg) | Standard Deviation 8.89 |
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.
Time frame: Baseline; from the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | 9.1 Beats per minute | Standard Deviation 9.3 |
| UMEC 125 µg | Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | 9.8 Beats per minute | Standard Deviation 10.16 |
| UMEC/VI 125/25 µg | Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period | 9.0 Beats per minute | Standard Deviation 9.04 |
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.
Time frame: Baseline; from the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | 7.8 Beats per minute | Standard Deviation 8.67 |
| UMEC 125 µg | Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | 9.9 Beats per minute | Standard Deviation 13.66 |
| UMEC/VI 125/25 µg | Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period | 9.3 Beats per minute | Standard Deviation 9.43 |
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.
Time frame: Baseline; from the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Maximum change from Baseline in QTcB | 17.1 Milliseconds | Standard Deviation 16.9 |
| Placebo | 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 | Maximum change from Baseline in QTcF | 15.6 Milliseconds | Standard Deviation 13.67 |
| Placebo | 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 | Maximum change from Baseline in PR interval | 12.4 Milliseconds | Standard Deviation 11.03 |
| UMEC 125 µg | 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 | Maximum change from Baseline in QTcB | 19.0 Milliseconds | Standard Deviation 17.62 |
| UMEC 125 µg | 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 | Maximum change from Baseline in QTcF | 16.9 Milliseconds | Standard Deviation 14.2 |
| UMEC 125 µg | 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 | Maximum change from Baseline in PR interval | 13.5 Milliseconds | Standard Deviation 10.26 |
| UMEC/VI 125/25 µg | 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 | Maximum change from Baseline in QTcF | 18.4 Milliseconds | Standard Deviation 14.42 |
| UMEC/VI 125/25 µg | 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 | Maximum change from Baseline in PR interval | 12.0 Milliseconds | Standard Deviation 9.79 |
| UMEC/VI 125/25 µg | 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 | Maximum change from Baseline in QTcB | 20.7 Milliseconds | Standard Deviation 17.14 |
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.
Time frame: From the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | 26 Participants |
| UMEC 125 µg | Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | 33 Participants |
| UMEC/VI 125/25 µg | Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period | 29 Participants |
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.
Time frame: Screening; from the start of study drug up to 52 weeks
Population: ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: unfavorable | 39 Participants |
| Placebo | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | No change or insignificant change | 46 Participants |
| Placebo | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: favorable | 3 Participants |
| Placebo | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Unable to compare | 2 Participants |
| UMEC 125 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Unable to compare | 8 Participants |
| UMEC 125 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: unfavorable | 86 Participants |
| UMEC 125 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: favorable | 6 Participants |
| UMEC 125 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | No change or insignificant change | 98 Participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Unable to compare | 6 Participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | No change or insignificant change | 110 Participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: favorable | 4 Participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation | Clinically significant change: unfavorable | 87 Participants |
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.
Time frame: From the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Not Clinically Significant | 52 participants |
| Placebo | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Unable to Evaluate | 0 participants |
| Placebo | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Clinically Significant | 25 participants |
| Placebo | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Normal | 32 participants |
| UMEC 125 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Clinically Significant | 58 participants |
| UMEC 125 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Unable to Evaluate | 0 participants |
| UMEC 125 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Not Clinically Significant | 105 participants |
| UMEC 125 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Normal | 64 participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Unable to Evaluate | 0 participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Normal | 71 participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Clinically Significant | 54 participants |
| UMEC/VI 125/25 µg | Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline | Abnormal - Not Clinically Significant | 101 participants |
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.
Time frame: From the start of study drug up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to the First On-treatment COPD Exacerbation | NA Days |
| UMEC 125 µg | Time to the First On-treatment COPD Exacerbation | NA Days |
| UMEC/VI 125/25 µg | Time to the First On-treatment COPD Exacerbation | NA Days |