Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
Brief Summary: This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.


Options:
A: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period (Baseline; Week 1 up to Week 4)
B: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)
C: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period (From the start of study medication until Visit 11 (Week 52)/Early Withdrawal); Number of Participants With Severe Asthma Exacerbations During the Treatment Period (From the start of study medication until Visit 11 (Week 52)/Early Withdrawal); Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline (Baseline and Week 12); Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline (Baseline and Week 28); Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline (Baseline and Week 52); Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Maximum Change From Baseline in Pulse Rate (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 (Baseline; Week 28, and Week 52); Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) (Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal); Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data (0-24 hours at Screening, Day 1, Week 28, and Week 52); Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data (0-24 hours at Screening, Day 1, Week 28, and Week 52)
D: safety: adverse events, vital sign, ECGs, and clinical laboratory test; PK： Cmax, tmax and AUC(0-t); PD: serum cortisol

Answer: A