Please select the outcome measures that correspond to the clinical trial below.
Title: DB2114930: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84 (Baseline and Day 84)
C: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) (From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)); Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46))
D: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)

Answer: B