Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-national, Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study With GSK 573719 as Monotherapy in Adult Subjects With Asthma
Brief Summary: This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence.

A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.


Options:
A: Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. (Baseline and 3 months)
B: Time to First Serious Asthma Exacerbation (Up to 21 months)
C: Percentage of subjects who have an asthma control test (ACT) total score of >=20 (Up to 24 weeks); Percentage of subjects with an increase from Baseline of >=3 in ACT total score (Baseline and up to 24 weeks)
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: D