Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Pharmacogenetics, GSK573719/GW642444
Brief summary
The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary Disease (COPD). This is a multi-centre, open-label study evaluating the safety of GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the morning. The target enrolment is approximately 120 subjects at approximately 20 study centres in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects will be instructed to administer medication once daily in the morning for the duration of the 52-week treatment period. Each subject should be advised to adhere to this dosing regimen throughout the study. There will be a total of 8 study visits including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by the phone contact approximately 1 week following the completion/withdrawal of treatment period. A subject will be considered to have completed the study upon completion of the last on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed appropriate COPD medication at the investigator's discretion.
Detailed description
The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary Disease (COPD). This is a multi-centre, open-label study evaluating the safety of GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the morning. The target enrolment is approximately 120 subjects at approximately 20 study centres in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of baseline safety evaluations and to obtain baseline measures of COPD status. Cardiovascular medical history/risk factors will be assessed at baseline. The following information will be collected from subjects receiving study medication and recorded in the eCRF: demography (including gender, ethnic origin and date of birth, height, weight), medical history (including duration of COPD and smoking history), COPD exacerbation assessment (documented history of ≥1 COPD exacerbation that required antibiotics/systemic corticosteroids or hospitalization in the past 12 months), concurrent medical conditions, and concomitant medication. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects will be instructed to administer medication once daily in the morning for the duration of the 52-week treatment period. Each subject should be advised to adhere to this dosing regimen throughout the study. There will be a total of 8 study visits including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by the phone contact approximately 1 week following the completion/withdrawal of treatment period. A subject will be considered to have completed the study upon completion of the last on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed appropriate COPD medication at the investigator's discretion. Primary endpoint is incidence and severity of adverse events. Secondary endpoints are clinical laboratory tests (hematology, clinical chemistry), change from baseline in vital signs (pulse rate and systolic and diastolic pressure), and 12-lead Electrocardiogram (ECG) assessments. And other endpoints are change from baseline in trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC), number of puffs of supplemental use of salbutamol, percentage of rescue-free days, percentage of symptom-free days, mean symptom scores, incidence of COPD exacerbations, and COPD device preference questionnaire.
Interventions
DRUGGSK573719/GW642444 Inhalation Powder
GSK573719/GW642444 inhalation powder inhaled orally once daily for 52 weeks.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient. * A signed and dated written informed consent prior to study participation. * Japanese subjects 40 years of age or older at screening. * Male or female subjects (female subjects who have child bearing potential has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly). * Diagnosis of COPD. * 10 pack-year or greater history of cigarette smoking. * Post-bronchodilator FEV1/FVC of \<0.7. * Predicted FEV1 of \<80%.
Exclusion criteria
* Women who are pregnant or lactating or are planning on becoming pregnant during the study. * A current diagnosis of asthma. * Respiratory disorders other than COPD. * Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled. * A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. * A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition. * Hospitalization for COPD or pneumonia within 12 weeks prior to screening. * Subjects with lung volume reduction surgery within the 12 months prior to screening. * Abnormal and clinically significant ECG findings at screening. * Significantly abnormal finding from clinical chemistry or hematology, tests at screening. * Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. * Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators via nebulized therapy. * Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening. * A know or suspected history of alcohol or drug abuse within 2 years prior to screening. * Affiliation with the investigational site. * Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the Fluticasone Furoate/GW642444 combination. * Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period | 52 weeks | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of \>=5%) and SAEs. |
| Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period | 52 weeks | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Change From Baseline in Blood Pressure | Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52. |
| Change From Baseline in Heart Rate | Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52. |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
| Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit). |
Countries
Japan
Participant flow
Recruitment details
131 participants (par.) comprised the All Subjects Enrolled Population (ASEP; all par. with records in the study database). One par. in the ASEP was withdrawn due to a Good Clinical Practice violation and was thus withdrawn from the Intent-to-Treat Population (comprised of all participants who received at least one dose of study drug; n=130).
Pre-assignment details
Following screening and a 2-week Run-in Period, during which participants were evaluated for Baseline safety and chronic obstructive pulmonary disease (COPD) status, eligible participants entered a 52-week Treatment Period, followed by a Follow-up Period.
Participants by arm
| Arm | Count |
|---|---|
| UMEC/VI 125/25 µg Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | UMEC/VI 125/25 µg |
|---|---|
| Age, Continuous | 70.4 Years STANDARD_DEVIATION 7.86 |
| Gender Female | 10 Participants |
| Gender Male | 120 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 130 |
| serious Total, serious adverse events | 16 / 130 |
Outcome results
Primary
Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
Time frame: 52 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC/VI 125/25 µg | Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period | Mild | 83 Participants |
| UMEC/VI 125/25 µg | Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period | Moderate | 20 Participants |
| UMEC/VI 125/25 µg | Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period | Severe | 10 Participants |
Primary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of \>=5%) and SAEs.
Time frame: 52 weeks
Population: Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC/VI 125/25 µg | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period | Any AE | 113 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period | Any SAE | 16 Participants |
Secondary
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, BL (Week -2), n=130 | 242.1 International Units/Liter (IU/L) | Standard Deviation 80.7 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 12, n=127 | 250.2 International Units/Liter (IU/L) | Standard Deviation 82.01 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 24, n=122 | 257.3 International Units/Liter (IU/L) | Standard Deviation 81.4 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 52, n=112 | 247.5 International Units/Liter (IU/L) | Standard Deviation 77.43 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, WD Visit, n=10 | 227.7 International Units/Liter (IU/L) | Standard Deviation 74.24 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 24/WD, n=129 | 254.2 International Units/Liter (IU/L) | Standard Deviation 80.75 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 52/WD, n=122 | 245.9 International Units/Liter (IU/L) | Standard Deviation 77.07 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, BL (Week -2), n=130 | 20.0 International Units/Liter (IU/L) | Standard Deviation 10.42 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 12, n=127 | 21.9 International Units/Liter (IU/L) | Standard Deviation 13.19 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 24, n=122 | 20.8 International Units/Liter (IU/L) | Standard Deviation 13.06 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 52, n=112 | 21.2 International Units/Liter (IU/L) | Standard Deviation 12.09 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, WD Visit, n=10 | 31.7 International Units/Liter (IU/L) | Standard Deviation 28.79 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 24/WD, n=129 | 21.1 International Units/Liter (IU/L) | Standard Deviation 13.56 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 52/WD, n=122 | 22.0 International Units/Liter (IU/L) | Standard Deviation 14.29 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, BL (Week -2), n=130 | 23.4 International Units/Liter (IU/L) | Standard Deviation 7.35 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 12, n=127 | 25.0 International Units/Liter (IU/L) | Standard Deviation 8.9 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 24, n=122 | 23.9 International Units/Liter (IU/L) | Standard Deviation 9.62 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 52, n=112 | 24.3 International Units/Liter (IU/L) | Standard Deviation 8.94 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, WD Visit, n=10 | 41.1 International Units/Liter (IU/L) | Standard Deviation 42.05 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 24/WD, n=129 | 24.7 International Units/Liter (IU/L) | Standard Deviation 14.48 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 52/WD, n=122 | 25.7 International Units/Liter (IU/L) | Standard Deviation 15.04 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, BL (Week -2), n=130 | 114.1 International Units/Liter (IU/L) | Standard Deviation 59.56 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 12, n=127 | 120.3 International Units/Liter (IU/L) | Standard Deviation 111.89 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 24, n=122 | 100.8 International Units/Liter (IU/L) | Standard Deviation 42.6 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 52, n=112 | 111.3 International Units/Liter (IU/L) | Standard Deviation 59.6 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, WD Visit, n=10 | 387.5 International Units/Liter (IU/L) | Standard Deviation 971.63 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 24/WD, n=129 | 124.0 International Units/Liter (IU/L) | Standard Deviation 271.9 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 52/WD, n=122 | 134.0 International Units/Liter (IU/L) | Standard Deviation 281.54 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, BL (Week -2), n=130 | 47.1 International Units/Liter (IU/L) | Standard Deviation 54.8 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 12, n=127 | 49.1 International Units/Liter (IU/L) | Standard Deviation 57.91 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 24, n=122 | 49.1 International Units/Liter (IU/L) | Standard Deviation 63.21 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 52, n=112 | 53.9 International Units/Liter (IU/L) | Standard Deviation 78.3 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, WD Visit, n=10 | 46.3 International Units/Liter (IU/L) | Standard Deviation 26.29 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 24/WD Visit, n=129 | 49.2 International Units/Liter (IU/L) | Standard Deviation 61.82 |
| UMEC/VI 125/25 µg | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 52/WD Visit, n=122 | 53.3 International Units/Liter (IU/L) | Standard Deviation 75.37 |
Secondary
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, BL (Week -2), n=130 | 0.54 Percentage of cells in blood | Standard Deviation 0.34 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 12, n=127 | 0.58 Percentage of cells in blood | Standard Deviation 0.424 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 24, n=122 | 0.59 Percentage of cells in blood | Standard Deviation 0.386 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 52, n=112 | 0.60 Percentage of cells in blood | Standard Deviation 0.615 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, WD Visit, n=10 | 0.35 Percentage of cells in blood | Standard Deviation 0.246 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 24/WD, n=129 | 0.58 Percentage of cells in blood | Standard Deviation 0.382 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 52/WD, n=122 | 0.58 Percentage of cells in blood | Standard Deviation 0.597 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, BL (Week -2), n=130 | 3.90 Percentage of cells in blood | Standard Deviation 3.752 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 12, n=127 | 3.73 Percentage of cells in blood | Standard Deviation 3.178 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24, n=122 | 4.07 Percentage of cells in blood | Standard Deviation 4.694 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52, n=112 | 3.54 Percentage of cells in blood | Standard Deviation 2.936 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, WD Visit, n=10 | 2.10 Percentage of cells in blood | Standard Deviation 1.662 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24/WD, n=129 | 3.97 Percentage of cells in blood | Standard Deviation 4.593 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52/WD, n=122 | 3.42 Percentage of cells in blood | Standard Deviation 2.876 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, BL (Week -2), n=130 | 29.07 Percentage of cells in blood | Standard Deviation 8.471 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 12, n=127 | 28.48 Percentage of cells in blood | Standard Deviation 7.703 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 24, n=122 | 28.40 Percentage of cells in blood | Standard Deviation 8.62 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 52, n=112 | 28.71 Percentage of cells in blood | Standard Deviation 7.906 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, WD Visit, n=10 | 21.28 Percentage of cells in blood | Standard Deviation 8.11 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 24/WD, n=129 | 28.12 Percentage of cells in blood | Standard Deviation 8.636 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 52/WD, n=122 | 28.10 Percentage of cells in blood | Standard Deviation 8.15 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, BL (Week -2), n=130 | 6.15 Percentage of cells in blood | Standard Deviation 1.758 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 12, n=127 | 6.33 Percentage of cells in blood | Standard Deviation 1.727 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 24, n=122 | 6.27 Percentage of cells in blood | Standard Deviation 1.541 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 52, n=112 | 6.20 Percentage of cells in blood | Standard Deviation 1.827 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, WD Visit, n=10 | 7.44 Percentage of cells in blood | Standard Deviation 1.29 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 24/WD, n=129 | 6.32 Percentage of cells in blood | Standard Deviation 1.541 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 52/WD, n=122 | 6.30 Percentage of cells in blood | Standard Deviation 1.818 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, BL (Week -2), n=130 | 60.34 Percentage of cells in blood | Standard Deviation 9.047 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 12, n=127 | 60.88 Percentage of cells in blood | Standard Deviation 8.88 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24, n=122 | 60.67 Percentage of cells in blood | Standard Deviation 9.595 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52, n=112 | 60.96 Percentage of cells in blood | Standard Deviation 8.714 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, WD Visit, n=10 | 68.83 Percentage of cells in blood | Standard Deviation 8.296 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24/WD, n=129 | 61.01 Percentage of cells in blood | Standard Deviation 9.538 |
| UMEC/VI 125/25 µg | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52/WD, n=122 | 61.60 Percentage of cells in blood | Standard Deviation 8.915 |
Secondary
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, BL (Week -2), n=130 | 2.2954 Millimoles/Liter (MMOL/L) | Standard Deviation 0.09315 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 12, n=127 | 2.2948 Millimoles/Liter (MMOL/L) | Standard Deviation 0.09903 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 24, n=122 | 2.2837 Millimoles/Liter (MMOL/L) | Standard Deviation 0.09096 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 52, n=112 | 2.2765 Millimoles/Liter (MMOL/L) | Standard Deviation 0.09993 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, WD Visit, n=10 | 2.2829 Millimoles/Liter (MMOL/L) | Standard Deviation 0.15878 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 24/WD, n=129 | 2.2842 Millimoles/Liter (MMOL/L) | Standard Deviation 0.09439 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 52/WD, n=122 | 2.2770 Millimoles/Liter (MMOL/L) | Standard Deviation 0.10506 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, BL (Week -2), n=130 | 103.7 Millimoles/Liter (MMOL/L) | Standard Deviation 2.65 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 12, n=127 | 105.7 Millimoles/Liter (MMOL/L) | Standard Deviation 2.51 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 24, n=122 | 105.7 Millimoles/Liter (MMOL/L) | Standard Deviation 2.7 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 52, n=112 | 105.5 Millimoles/Liter (MMOL/L) | Standard Deviation 2.93 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, WD Visit, n=10 | 104.2 Millimoles/Liter (MMOL/L) | Standard Deviation 3.65 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 24/WD, n=129 | 105.6 Millimoles/Liter (MMOL/L) | Standard Deviation 2.79 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 52/WD, n=122 | 105.4 Millimoles/Liter (MMOL/L) | Standard Deviation 3 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, BL (Week -2), n=130 | 6.4447 Millimoles/Liter (MMOL/L) | Standard Deviation 1.8664 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 12, n=127 | 6.3343 Millimoles/Liter (MMOL/L) | Standard Deviation 1.63238 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 24, n=122 | 6.7313 Millimoles/Liter (MMOL/L) | Standard Deviation 2.20449 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 52, n=112 | 6.6325 Millimoles/Liter (MMOL/L) | Standard Deviation 1.81891 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, WD Visit, n=10 | 6.5280 Millimoles/Liter (MMOL/L) | Standard Deviation 1.5207 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 24/WD, n=129 | 6.7085 Millimoles/Liter (MMOL/L) | Standard Deviation 2.15445 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 52/WD, n=122 | 6.6239 Millimoles/Liter (MMOL/L) | Standard Deviation 1.79105 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, BL (Week -2), n=130 | 25.7 Millimoles/Liter (MMOL/L) | Standard Deviation 2.32 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 12, n=127 | 25.1 Millimoles/Liter (MMOL/L) | Standard Deviation 2.29 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 24, n=122 | 24.1 Millimoles/Liter (MMOL/L) | Standard Deviation 2.31 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 52, n=112 | 23.8 Millimoles/Liter (MMOL/L) | Standard Deviation 2.18 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, WD Visit, n=10 | 24.3 Millimoles/Liter (MMOL/L) | Standard Deviation 3.5 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 24/WD, n=129 | 24.2 Millimoles/Liter (MMOL/L) | Standard Deviation 2.41 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 52/WD, n=122 | 23.9 Millimoles/Liter (MMOL/L) | Standard Deviation 2.3 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, BL (Week -2), n=130 | 4.29 Millimoles/Liter (MMOL/L) | Standard Deviation 0.38 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 12, n=127 | 4.34 Millimoles/Liter (MMOL/L) | Standard Deviation 0.384 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 24, n=122 | 4.33 Millimoles/Liter (MMOL/L) | Standard Deviation 0.374 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 52, n=112 | 4.31 Millimoles/Liter (MMOL/L) | Standard Deviation 0.362 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, WD Visit, n=10 | 4.42 Millimoles/Liter (MMOL/L) | Standard Deviation 0.301 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 24/WD, n=129 | 4.33 Millimoles/Liter (MMOL/L) | Standard Deviation 0.366 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 52/WD, n=122 | 4.32 Millimoles/Liter (MMOL/L) | Standard Deviation 0.357 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, BL (Week -2), n=130 | 141.4 Millimoles/Liter (MMOL/L) | Standard Deviation 2.09 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 12, n=127 | 142.3 Millimoles/Liter (MMOL/L) | Standard Deviation 1.95 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 24, n=122 | 142.3 Millimoles/Liter (MMOL/L) | Standard Deviation 2.03 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 52, n=112 | 141.4 Millimoles/Liter (MMOL/L) | Standard Deviation 2.26 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, WD Visit, n=10 | 140.4 Millimoles/Liter (MMOL/L) | Standard Deviation 3.72 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 24/WD, n=129 | 142.2 Millimoles/Liter (MMOL/L) | Standard Deviation 2.21 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 52/WD, n=122 | 141.4 Millimoles/Liter (MMOL/L) | Standard Deviation 2.41 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, BL (Week -2), n=130 | 0.9714 Millimoles/Liter (MMOL/L) | Standard Deviation 0.15901 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, Week 12, n=127 | 1.0124 Millimoles/Liter (MMOL/L) | Standard Deviation 0.16447 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, Week 24, n=122 | 0.9975 Millimoles/Liter (MMOL/L) | Standard Deviation 0.16216 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, Week 52, n=112 | 0.9448 Millimoles/Liter (MMOL/L) | Standard Deviation 0.16492 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, WD Visit, n=10 | 0.9913 Millimoles/Liter (MMOL/L) | Standard Deviation 0.17558 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, Week 24/WD, n=129 | 0.9985 Millimoles/Liter (MMOL/L) | Standard Deviation 0.16349 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, BL (Week -2), n=130 | 0.9486 Millimoles/Liter (MMOL/L) | Standard Deviation 0.16555 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Phosphorous Inorganic, Week 52/WD, n=122 | 5.2660 Millimoles/Liter (MMOL/L) | Standard Deviation 1.52578 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 12, n=127 | 5.4764 Millimoles/Liter (MMOL/L) | Standard Deviation 1.80029 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 24, n=122 | 5.4998 Millimoles/Liter (MMOL/L) | Standard Deviation 1.50802 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 52, n=112 | 5.4570 Millimoles/Liter (MMOL/L) | Standard Deviation 1.66582 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, WD Visit, n=10 | 5.4335 Millimoles/Liter (MMOL/L) | Standard Deviation 2.05521 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 24/WD, n=129 | 5.4856 Millimoles/Liter (MMOL/L) | Standard Deviation 1.52903 |
| UMEC/VI 125/25 µg | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 52/WD, n=122 | 5.4551 Millimoles/Liter (MMOL/L) | Standard Deviation 1.69111 |
Secondary
Change From Baseline in Blood Pressure
Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 4, n=128 | 1.1 Millimeters of Mercury (mmHg) | Standard Deviation 12.27 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 8, n=127 | 2.0 Millimeters of Mercury (mmHg) | Standard Deviation 13.79 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 12, n=127 | 2.5 Millimeters of Mercury (mmHg) | Standard Deviation 13.62 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 24, n=122 | 2.7 Millimeters of Mercury (mmHg) | Standard Deviation 14.8 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 36, n=116 | -3.3 Millimeters of Mercury (mmHg) | Standard Deviation 13.8 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 52, n=112 | 0.4 Millimeters of Mercury (mmHg) | Standard Deviation 13.82 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, WD Visit, n=10 | -2.3 Millimeters of Mercury (mmHg) | Standard Deviation 18.62 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 24/WD, n=129 | 2.5 Millimeters of Mercury (mmHg) | Standard Deviation 15.09 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | SBP, Week 52/WD, n=122 | 0.2 Millimeters of Mercury (mmHg) | Standard Deviation 14.19 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 4, n=128 | 1.0 Millimeters of Mercury (mmHg) | Standard Deviation 9.21 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 8, n=127 | 1.4 Millimeters of Mercury (mmHg) | Standard Deviation 9.99 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 12, n=127 | 0.9 Millimeters of Mercury (mmHg) | Standard Deviation 10.71 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 24, n=122 | 0.9 Millimeters of Mercury (mmHg) | Standard Deviation 10.81 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 36, n=116 | -1.5 Millimeters of Mercury (mmHg) | Standard Deviation 11.1 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 52, n=112 | 0.6 Millimeters of Mercury (mmHg) | Standard Deviation 10.23 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, WD Visit, n=10 | -2.0 Millimeters of Mercury (mmHg) | Standard Deviation 11.05 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 24/WD, n=129 | 0.6 Millimeters of Mercury (mmHg) | Standard Deviation 10.92 |
| UMEC/VI 125/25 µg | Change From Baseline in Blood Pressure | DBP, Week 52/WD, n=122 | 0.4 Millimeters of Mercury (mmHg) | Standard Deviation 10.28 |
Secondary
Change From Baseline in Heart Rate
Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 52/WD, n=122 | 0.1 Beats per minute | Standard Deviation 10.9 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 4, n=128 | -0.7 Beats per minute | Standard Deviation 10.21 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 8, n=127 | -0.7 Beats per minute | Standard Deviation 9.39 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 12, n=127 | -1.4 Beats per minute | Standard Deviation 10.81 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 24, n=122 | -0.5 Beats per minute | Standard Deviation 10.63 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 36, n=116 | -2.2 Beats per minute | Standard Deviation 10.56 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 52, n=112 | -0.7 Beats per minute | Standard Deviation 10.63 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | WD Visit, n=10 | 9.0 Beats per minute | Standard Deviation 10.46 |
| UMEC/VI 125/25 µg | Change From Baseline in Heart Rate | Week 24/WD, n=129 | -0.1 Beats per minute | Standard Deviation 10.67 |
Secondary
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, BL (Week -2), n=130 | 3.736 Micromoles/Liter (µM/L) | Standard Deviation 1.7659 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 12, n=127 | 3.514 Micromoles/Liter (µM/L) | Standard Deviation 1.6731 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 24, n=122 | 3.350 Micromoles/Liter (µM/L) | Standard Deviation 1.4975 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 52, n=112 | 3.680 Micromoles/Liter (µM/L) | Standard Deviation 1.6426 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, WD Visit, n=10 | 3.249 Micromoles/Liter (µM/L) | Standard Deviation 0.5407 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 24/WD, n=129 | 3.340 Micromoles/Liter (µM/L) | Standard Deviation 1.4632 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 52/WD, n=122 | 3.644 Micromoles/Liter (µM/L) | Standard Deviation 1.5846 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, BL (Week -2), n=130 | 7.064 Micromoles/Liter (µM/L) | Standard Deviation 2.8991 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 12, n=127 | 6.975 Micromoles/Liter (µM/L) | Standard Deviation 2.7725 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 24, n=122 | 6.728 Micromoles/Liter (µM/L) | Standard Deviation 2.5424 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 52, n=112 | 7.008 Micromoles/Liter (µM/L) | Standard Deviation 2.9302 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, WD Visit, n=10 | 5.985 Micromoles/Liter (µM/L) | Standard Deviation 2.4517 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 24/WD, n=129 | 6.641 Micromoles/Liter (µM/L) | Standard Deviation 2.5348 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 52/WD, n=122 | 6.924 Micromoles/Liter (µM/L) | Standard Deviation 2.8987 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, BL (Week -2), n=130 | 10.799 Micromoles/Liter (µM/L) | Standard Deviation 4.3585 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 12, n=127 | 10.489 Micromoles/Liter (µM/L) | Standard Deviation 4.1067 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 24, n=122 | 10.078 Micromoles/Liter (µM/L) | Standard Deviation 3.6643 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 52, n=112 | 10.687 Micromoles/Liter (µM/L) | Standard Deviation 4.2603 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, WD Visit, n=10 | 9.234 Micromoles/Liter (µM/L) | Standard Deviation 2.8156 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 24/WD, n=129 | 9.982 Micromoles/Liter (µM/L) | Standard Deviation 3.6261 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 52/WD, n=122 | 10.568 Micromoles/Liter (µM/L) | Standard Deviation 4.1714 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, BL (Week -2), n=130 | 74.3036 Micromoles/Liter (µM/L) | Standard Deviation 19.60971 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 12, n=127 | 74.3047 Micromoles/Liter (µM/L) | Standard Deviation 19.3291 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 24, n=122 | 73.2633 Micromoles/Liter (µM/L) | Standard Deviation 18.90496 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 52, n=112 | 75.6609 Micromoles/Liter (µM/L) | Standard Deviation 18.69402 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, WD Visit, n=10 | 71.8692 Micromoles/Liter (µM/L) | Standard Deviation 10.60022 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 24/WD, n=129 | 73.2692 Micromoles/Liter (µM/L) | Standard Deviation 18.5596 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 52/WD, n=122 | 75.3501 Micromoles/Liter (µM/L) | Standard Deviation 18.16682 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, BL (Week -2), n=130 | 357.8408 Micromoles/Liter (µM/L) | Standard Deviation 81.73895 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 12, n=127 | 353.2737 Micromoles/Liter (µM/L) | Standard Deviation 81.17581 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 24, n=122 | 348.2993 Micromoles/Liter (µM/L) | Standard Deviation 80.93244 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 52, n=112 | 353.2687 Micromoles/Liter (µM/L) | Standard Deviation 89.55111 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, WD Visit, n=10 | 343.7944 Micromoles/Liter (µM/L) | Standard Deviation 87.4084 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 24/WD, n=129 | 349.1799 Micromoles/Liter (µM/L) | Standard Deviation 80.95415 |
| UMEC/VI 125/25 µg | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 52, n=122 | 352.4921 Micromoles/Liter (µM/L) | Standard Deviation 89.06027 |
Secondary
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, BL (Week -2), n=130 | 0.245 10^9 cells/Liter (GI/L) | Standard Deviation 0.2324 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 12, n=127 | 0.225 10^9 cells/Liter (GI/L) | Standard Deviation 0.1815 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24, n=122 | 0.260 10^9 cells/Liter (GI/L) | Standard Deviation 0.3243 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52, n=112 | 0.219 10^9 cells/Liter (GI/L) | Standard Deviation 0.1992 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, WD Visit, n=10 | 0.135 10^9 cells/Liter (GI/L) | Standard Deviation 0.1031 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24/WD, n=129 | 0.254 10^9 cells/Liter (GI/L) | Standard Deviation 0.3171 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52/WD, n=122 | 0.212 10^9 cells/Liter (GI/L) | Standard Deviation 0.1942 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, BL (Week -2), n=130 | 3.874 10^9 cells/Liter (GI/L) | Standard Deviation 1.2587 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 12, n=127 | 3.798 10^9 cells/Liter (GI/L) | Standard Deviation 1.2169 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24, n=122 | 3.946 10^9 cells/Liter (GI/L) | Standard Deviation 1.5517 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52, n=112 | 3.899 10^9 cells/Liter (GI/L) | Standard Deviation 1.5434 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, WD Visit, n=10 | 4.860 10^9 cells/Liter (GI/L) | Standard Deviation 2.0869 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24/WD, n=129 | 3.953 10^9 cells/Liter (GI/L) | Standard Deviation 1.5326 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52/WD, n=122 | 3.978 10^9 cells/Liter (GI/L) | Standard Deviation 1.606 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, BL (Week -2), n=130 | 234.3 10^9 cells/Liter (GI/L) | Standard Deviation 54.92 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 12, n=127 | 238.6 10^9 cells/Liter (GI/L) | Standard Deviation 56.35 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 24, n=122 | 239.3 10^9 cells/Liter (GI/L) | Standard Deviation 59.54 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 52, n=112 | 233.8 10^9 cells/Liter (GI/L) | Standard Deviation 58.63 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, WD Visit, n=10 | 232.0 10^9 cells/Liter (GI/L) | Standard Deviation 84.03 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 24/WD, n=129 | 240.0 10^9 cells/Liter (GI/L) | Standard Deviation 60.02 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 52/WD, n=122 | 233.6 10^9 cells/Liter (GI/L) | Standard Deviation 60.65 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, BL (Week -2), n=130 | 6.38 10^9 cells/Liter (GI/L) | Standard Deviation 1.588 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 12, n=127 | 6.18 10^9 cells/Liter (GI/L) | Standard Deviation 1.443 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 24, n=122 | 6.39 10^9 cells/Liter (GI/L) | Standard Deviation 1.803 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 52, n=112 | 6.30 10^9 cells/Liter (GI/L) | Standard Deviation 1.892 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, WD Visit, n=10 | 6.88 10^9 cells/Liter (GI/L) | Standard Deviation 2.203 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 24/WD, n=129 | 6.37 10^9 cells/Liter (GI/L) | Standard Deviation 1.778 |
| UMEC/VI 125/25 µg | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 52/WD, n=122 | 6.35 10^9 cells/Liter (GI/L) | Standard Deviation 1.916 |
Secondary
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Week -2), n=130 | 0.4460 Proportion | Standard Deviation 0.03857 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 12, n=127 | 0.4534 Proportion | Standard Deviation 0.03575 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 24, n=122 | 0.4515 Proportion | Standard Deviation 0.0372 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 52, n=112 | 0.4517 Proportion | Standard Deviation 0.04063 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WD Visit, n=10 | 0.4473 Proportion | Standard Deviation 0.0397 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 24/WD, n=129 | 0.4512 Proportion | Standard Deviation 0.03724 |
| UMEC/VI 125/25 µg | Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 52/WD, n=122 | 0.4513 Proportion | Standard Deviation 0.04041 |
Secondary
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, BL (Week -2), n=130 | 145.1 Grams/Liter (G/L) | Standard Deviation 13.35 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, Week 12, n=127 | 148.2 Grams/Liter (G/L) | Standard Deviation 13.02 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, Week 24, n=122 | 148.1 Grams/Liter (G/L) | Standard Deviation 13.58 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, Week 52, n=112 | 148.2 Grams/Liter (G/L) | Standard Deviation 14.02 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoblobin, WD Visit, n=10 | 146.6 Grams/Liter (G/L) | Standard Deviation 12.82 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, Week 24/WD, n=129 | 148.0 Grams/Liter (G/L) | Standard Deviation 13.53 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Hemoglobin, Week 52/WD, n=122 | 148.0 Grams/Liter (G/L) | Standard Deviation 13.88 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, BL (Week -2), n=130 | 42.5 Grams/Liter (G/L) | Standard Deviation 2.58 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, Week 12, n=127 | 42.9 Grams/Liter (G/L) | Standard Deviation 2.44 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, Week 24, n=122 | 42.4 Grams/Liter (G/L) | Standard Deviation 2.76 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, Week 52, n=112 | 41.9 Grams/Liter (G/L) | Standard Deviation 2.96 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, WD Visit, n=10 | 41.3 Grams/Liter (G/L) | Standard Deviation 3.68 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, Week 24/WD, n=129 | 42.3 Grams/Liter (G/L) | Standard Deviation 2.8 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Albumin, Week 52/WD, n=122 | 41.9 Grams/Liter (G/L) | Standard Deviation 3.01 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, BL (Week -2), n=130 | 70.9 Grams/Liter (G/L) | Standard Deviation 4.2 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, Week 12, n=127 | 71.8 Grams/Liter (G/L) | Standard Deviation 4.5 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, Week 24, n=122 | 71.2 Grams/Liter (G/L) | Standard Deviation 4.2 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, Week 52, n=112 | 70.8 Grams/Liter (G/L) | Standard Deviation 4.78 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, WD Visit, n=10 | 68.7 Grams/Liter (G/L) | Standard Deviation 5.46 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, Week 24/WD, n=129 | 71.0 Grams/Liter (G/L) | Standard Deviation 4.22 |
| UMEC/VI 125/25 µg | Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD) | Total Protein, Week 52/WD, n=122 | 70.6 Grams/Liter (G/L) | Standard Deviation 4.85 |
Secondary
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Time frame: Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | BL (Week -2), Abnormal NCS, n=130 | 45 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | BL (Week -2), Abnormal CS, n=130 | 2 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 12, Abnormal NCS, n=127 | 50 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 12, Abnormal CS, n=127 | 2 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 24, Abnormal NCS, n=122 | 43 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 24, Abnormal CS, n=122 | 3 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 36, Abnormal NCS, n=116 | 45 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 36, Abnormal CS, n=116 | 2 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 52, Abnormal NCS, n=112 | 47 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 52, Abnormal CS, n=112 | 2 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | WD Visit, Abnormal NCS, n=9 | 4 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | WD Visit, Abnormal CS, n=9 | 0 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 24/WD, Abnormal NCS, n=128 | 46 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 24/WD, Abnormal CS, n=128 | 3 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 52/WD, Abnormal NCS, n=121 | 51 Participants |
| UMEC/VI 125/25 µg | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points | Week 52/WD, Abnormal CS, n=121 | 2 Participants |