Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Single-dose, Double-blind, Placebo-controlled, 5-way Crossover Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With and Without Magnesium Stearate in Asthmatic Patients
Brief Summary: This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients. In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.


Options:
A: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)
B: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
C: Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1 (on going)
D: 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))

Answer: C