Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Dose Ascending, 2-cohort, Parallel Group Study to Examine the Safety, Tolerability and Pharmacokinetics of Once-daily Inhaled Doses of GSK573719 Formulated With the Excipient Magnesium Stearatein COPD Subjects for 7 Days
Brief Summary: The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to both healthy volunteers and to COPD patients before. This study will assess a new formulation of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less likely to deteriorate in its container, it is mixed with an inactive substance that helps to to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance. MgSt itself is not a medicine but is approved as a food ingredient and has also has been approved to be used in a number of marketed medical inhalers. The purpose of this study is to assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed dosing in group 1 without any significant safety concerns. The following safety measures will be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung function and 24 hour monitoring of the heart. We will also take blood and urine samples to measure medication levels in the body.

GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of their centres in the UK.


Options:
A: adverse events, cardiac and ECG parameters, vital signs, lung function and clinical laboratory safety assessments (From dosing to 24hr post-dose)
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
C: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
D: Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE) (From start of treatment to study day 12); Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7 (Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)); Mean Heart Rate (HR) on Days 1 and 7 (Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)); Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7 (Day 1 and Day 7); Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7 (Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)); Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7 (Screening and Day 7); Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7 (Day 7); Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7 (Screening, Day 1, and Day 7); Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period (Day 1 to Day 7); Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7 (Day 1 and Day 7); Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7 (Day 1 and Day 7); Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7 (Day 1 and Day 7); Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7 (Day 1 and Day 7); Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7 (Day 1 and Day 7); Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7 (Day 1 and Day 7); Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7 (Day 1 and Day 7)

Answer: D