Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Single-dose, Dose Ascending, Double-blind, Placebo Controlled, Four-way, Incomplete Block Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in COPD Patients.
Brief Summary: This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared in the form of a salt, and inactive ingredients (excipients) are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the 'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate (instead of cellobiose octaacetate). Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This study will be the first time the new 'M' salt form of the study drug will be given to COPD patients.


Options:
A: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
B: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period (From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54)); Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period (Baseline and Day 1 of each treatment period (up to Study Day 54))
C: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 (Baseline and Week 12)
D: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)

Answer: B