Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone
Brief Summary: This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)


Options:
A: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period (Baseline and Week 12)
B: The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (12 weeks)
C: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 15 of each treatment period (up to Study Day 71)); Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period (Day 15 of each treatment period (up to Study Day 71)); Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) (From Baseline until the end of Treatment Period 3 (up to Study Day 70)); Number of Participants With Asthma Exacerbations During the Treatment Period (From Baseline until the end of Treatment Period 3 (up to Study Day 70)); Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70))); Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Change From Baseline in Hematocrit on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70)); Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period (Baseline and Day 14 of each treatment period (up to Study Day 70))); Urine pH on Day 14 of Each Treatment Period (Day 14 of each treatment period (up to Study Day 70)); Urine Specific Gravity on Day 14 of Each Treatment Period (Day 14 of each treatment period (up to Study Day 70)); Number of Participants With the Indicated Abnormal Electrocardiogram Findings (Day 14 of each treatment period (up to Study Day 70)); Number of Participants With the Indicated 24 Hour Holter Findings (Day 14 of each treatment period (up to Study Day 70))
D: Asthma exacerbation rate per patient per year

Answer: D