A 2-wk Study to Evaluate the Safety, Tolerability,Pharmacodynamics and Pharmacokinetics of GW642444H(100 Administered Once Daily in the Morning Via DISKUS™ Dry-powder Inhaler)Compared With SEREVENT(Salmeterol)(50mcg Administered Twice Daily Via DISKUS Dry-powder Inhaler)and Placebo in Subject w/COPD

简要总结

详细描述

主要结局

次要结局

• Change From Baseline in Pre-dose Weighted Mean Heart Rate (HR) Derived From 28.5 Hour (h) Ambulatory Blood Pressure Monitoring (ABPM) at Day 7 and 14(Baseline (Day 1, pre-dose) up to Day 14)
• Change From Baseline in 0-4 h Weighted Mean HR Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15(Baseline (Day 1, pre-dose) up to Day 15)
• Change From Baseline in 0-24 h Weighted Mean HR Derived From 28.5 ABPM at Day 7 and 14(Baseline (Day 1, pre-dose) up to Day 15)
• Change From Baseline in Maximum HR During 0-4 h Derived From 28.5 h ABPM at Day 1, 2, 7, 8, 14 and 15(Baseline (Day 1, pre-dose) up to Day 15)
• Mean Weighted Mean HR at 0-4 h, Weighted Mean HR at 0-24 h and Maximum HR at 0-4 h Derived From 28.5 h ABPM(Day 1 up to Day 15)
• Mean Hourly HR 0-24 h at Day 1, 7 and 14(Day 1 up to Day 14)
• Mean Maximum Hourly HR 0-24 h at Day 1, 7 and 14(Day 1 up to Day 14)
• Change From Baseline in Weighted Mean Systolic and Diastolic Blood Pressure (SBP and DBP) Derived From 28.5 h ABPM Over Time(Baseline (Day 1, pre-dose) up to Day 15)
• Change From Baseline in Maximum SBP and Minimum DBP Derived From 28.5 h ABPM Over Time(Baseline (Day 1, pre-dose) up to Day 15)
• Mean Weighted Mean SBP and DBP at 0-4 h, Weighted Mean SBP and DBP at 0-24 h and Maximum SBP and Minimum DBP at 0-4 h Derived From 28.5 h ABPM(Day 1 up to Day 15)
• Change From Baseline in QTc by Federicia's Method (F) and QTc Bazett's Method (B) Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead Electrocardiogram (ECG) Over Time(Baseline (Day 1, pre-dose) up to Day 15)
• Mean QTcF and QTcB Values at Pre-dose, Weighted Mean 0-4 h and Maximum 0-4 h Derived From 12-lead ECG Over Time(Day 1 up to Day 15)
• Mean of Hourly Maximums QTcF and QTcB Derived From 24 h 3-lead Holter ECG Monitoring Over Time(Day 1 up to Day 14)
• Number of Events of Supra Ventricular Ectopics, Ventricular Ectopics and Ventricular Runs Per 24 h Derived From 3-lead Holter ECG Monitoring Over Time(Day 1 up to Day 14)
• Number of Participants With Biochemistry Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14(Baseline (Day 1) up to Day 14)
• Number of Participants With Hematology Abnormal Change From Baseline Values Relative to the Normal Range at Day 7 and 14(Baseline (Day 1) up to Day 14)
• Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Pre-dose, Weighted Mean FEV1 at 0-4 h and Maximum FEV1 0-4 h Over Time(Baseline (Day 1, pre-dose) up to Day 15)
• Mean FEV1 Weighted Mean FEV1 at 0-4 h and Maximum FEV1 at 0-4 h Over Time(Day 1 up to Day 15)
• Change From Baseline in Weighted Mean FEV1 Over 22- 24 h on Days 1, 7 and 14(Baseline (Day 1, pre-dose) up to Day 15)
• Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over Time(Up to Follow-up (Day 17))
• Mean Use of Rescue Medication Over Period(Up to Follow-up (Day 17))
• Number of Participants With Rescue Free Days(Up to Follow-up (Day 17))
• Change From Baseline in Pre-dose Fasting Glucose and Potassium at Day 7 and 14(Baseline (Day 1, pre-dose) up to Day 14)
• Change From Baseline in Weighted Mean Glucose and Potassium 0-4 h, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time(Baseline (Day 1, pre-dose) up to Day 15)
• Mean Weighted Mean 0-4 h of Glucose and Potassium, Maximum Glucose 0-4 h and Minimum Potassium 0-4 h Over Time(Day 1 up to Day 15)
• AUC of GW642444H Over 0 to 4 h (AUC [0-4]) on Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Maximum Concentration (Cmax) of GW642444H at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Time to Maximum Concentration (Tmax) and Time of Last Quantifiable Concentration (Tlast) of GW642444H at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• AUC (0-4) of CCI2189 at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Cmax of CCI2189 at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• AUC (0-4) of GW630200 and GSK932009 at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Cmax of GW630200 and GSK932009 at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Time to Maximum Concentration (Tmax) of CCI2189, GW630200 and GSK932009 at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• AUC (0-4) of Salmeterol at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Cmax of Salmeterol at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))
• Tmax of Salmeterol at Day 1, 7 and 14(Day 1 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose), Day 7 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose) and Day 14 (pre-dose, 5 min, 1 h, 2 h and 4 h post-dose))