Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Dose-ranging Study to Evaluate GSK573719 in Combination With Fluticasone Furoate, Fluticasone Furoate Alone, and an Active Control of Fluticasone Furoate/Vilanterol Combination in Subjects With Asthma
Brief Summary: Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.


Options:
A: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period (Baseline and Week 12)
B: Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period (Baseline and Weeks 1-12 (up to Day 84))
C: 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)
D: 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))

Answer: C