Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00519376
Recruitment Status : Completed
First Posted : August 22, 2007
Results First Posted : December 30, 2013
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: GW642444M
Drug: GW642444H
Drug: placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details Participants meeting eligibility criteria at screening were randomized and entered a treatment period. Participants were then randomized to 4 treatment periods in one of 16 sequences (seq) each lasting 1 day and separated by a 7 - 14 day washout period.
Arm/Group Title Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB
Hide Arm/Group Description Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Period Title: Treatment Period 1
Started 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 1
Started 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Treatment Period 2
Started 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0
Reason Not Completed
Unable Evaluate Cardiovascular Endpoints             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Period Title: Washout Period 2
Started 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Treatment Period 3
Started 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 3
Started 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Completed 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Treatment Period 4
Started 2 2 2 2 1 1 1 1 1 1 1 1 0 1 1 1
Completed 2 2 1 2 1 1 1 1 1 1 1 1 0 1 1 1
Not Completed 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Arm/Group Title GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq
Hide Arm/Group Description Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
62.3  (7.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
3
  15.0%
Male
17
  85.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White/Caucasian/European Heritage Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: all participants who received at least one dose of study medication
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 12
Measure Type: Number
Unit of Measure: Participants
Any AE 2 1 2 0 0
Any SAE 0 0 0 0 0
2.Primary Outcome
Title 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
Hide Description Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (GI/L)
Basophils, n=19, 20, 19, 8, 11 0.004  (0.0154) 0.001  (0.0168) 0.001  (0.0133) 0.004  (0.0185) -0.004  (0.0211)
Eosinophils, n=19, 20, 19, 8, 11 0.003  (0.1771) -0.045  (0.0707) -0.023  (0.0921) -0.031  (0.0895) -0.002  (0.0637)
Lymphocytes, n=19, 20, 19, 8, 11 0.068  (0.4094) 0.021  (0.3719) -0.126  (0.2608) -0.146  (0.4055) -0.116  (0.3261)
Monocytes, n=19, 20, 19, 8, 11 0.006  (0.1323) -0.027  (0.1390) 0.007  (0.0917) -0.018  (0.1331) 0.025  (0.1347)
Total Neutrophils, n=19, 20, 19, 8, 11 -0.100  (0.6174) 0.188  (0.9814) 0.343  (0.9674) 0.201  (0.6165) -0.021  (0.7415)
Platelet count, n=19, 20, 19, 8, 11 5.0  (16.16) 8.2  (18.38) 8.5  (15.33) 9.5  (13.72) -1.1  (10.82)
WBC, n=19, 20, 19, 8, 11 -0.02  (0.807) 0.14  (1.215) 0.20  (1.029) 0.04  (1.094) -0.12  (0.774)
3.Primary Outcome
Title Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Hemoglobin, n=19, 20, 19, 8, 11 -0.4  (6.21) -1.2  (6.41) -0.5  (4.02) -3.0  (4.21) 0.8  (5.47)
MCHC, n=19, 20, 19, 8, 11 -3.5  (5.23) -5.8  (22.66) 1.7  (5.58) 5.3  (3.65) -0.8  (6.27)
4.Primary Outcome
Title Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (TI/L)
Reticulocytes, n=19, 19, 19, 8, 11 -0.00714  (0.021416) -0.00065  (0.019905) 0.00208  (0.017391) 0.00905  (0.016387) 0.00094  (0.012676)
RBC, n=19, 20, 19, 8, 11 0.00  (0.194) 0.01  (0.193) -0.01  (0.137) -0.11  (0.173) 0.05  (0.186)
5.Primary Outcome
Title Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: Proportion of 1.0
0.0044  (0.02025) -0.0024  (0.02132) -0.0018  (0.01674) -0.0161  (0.01408) 0.0036  (0.02025)
6.Primary Outcome
Title Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: 10^15 femtoliters (fL) per cell
0.6  (1.67) -0.2  (2.09) -0.2  (1.96) -1.0  (0.76) -0.5  (1.81)
7.Primary Outcome
Title Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 20 19 8 11
Mean (Standard Deviation)
Unit of Measure: 10^12 picograms (pg) per cell
-0.11  (0.403) -0.22  (0.465) 0.24  (0.581) 0.14  (0.342) -0.21  (0.528)
8.Primary Outcome
Title 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
Hide Description Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 15 17 7 10
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALT, n=17, 15, 17, 7, 10 0.1  (3.89) -0.5  (2.00) 1.1  (2.75) -0.6  (1.51) 1.0  (4.08)
ALP, n=17, 15, 17, 7, 10 0.4  (10.05) 1.6  (4.90) 0.6  (5.93) -0.4  (2.37) 1.2  (6.91)
AST, n=17, 13, 17, 6, 9 -0.1  (5.46) -0.6  (2.87) -1.6  (2.69) -1.7  (1.03) 2.1  (5.84)
GGT, n=17, 15, 17, 7, 10 -2.0  (2.37) -0.9  (3.99) -0.5  (5.06) -1.6  (2.88) 0.5  (5.21)
CK n=17, 15, 17, 7, 10 -18.1  (29.90) -20.5  (36.07) -38.1  (69.67) -3.1  (15.99) -19.9  (20.89)
9.Primary Outcome
Title Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 15 17 7 10
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Albumin, n=17, 15, 17, 7, 10 -0.9  (2.30) -0.1  (1.85) -0.2  (1.51) -0.9  (1.95) 0.1  (0.88)
Total protein, n=17, 15, 17, 7, 10 -1.7  (4.22) -0.5  (2.59) 0.1  (2.34) -0.7  (3.40) 0.8  (1.55)
10.Primary Outcome
Title Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 15 17 7 10
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Cholesterol, n=17, 15, 17, 7, 10 -0.085  (0.3416) 0.121  (0.3764) 0.032  (1.2588) -0.251  (0.5630) 0.082  (0.2447)
Chloride, n=17, 15, 17, 7, 10 0.6  (2.65) 0.0  (2.80) -0.3  (2.31) -0.3  (1.70) 0.6  (1.43)
Potassium, n=17, 13, 17, 6, 9 0.12  (0.263) 0.14  (0.384) 0.06  (0.374) 0.10  (0.358) 0.16  (0.305)
Sodium, n=17, 15, 17, 7, 10 0.9  (2.03) -0.1  (1.83) 0.4  (1.41) 0.0  (1.15) 0.9  (1.79)
Triglyceride, n=17, 15, 17, 7, 10 -0.106  (0.4625) 0.024  (0.5789) -0.015  (0.3800) -0.300  (0.5812) 0.142  (0.2629)
Urea, n=17, 15, 17, 7, 10 0.29  (1.092) -0.17  (0.964) -0.38  (1.109) -0.17  (0.427) 0.20  (0.918)
11.Primary Outcome
Title Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 15 17 7 10
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Creatinine, n=17, 15, 17, 7, 10 3.5  (5.96) 4.9  (5.62) 4.9  (6.62) 1.0  (5.07) 1.5  (5.28)
Total Bilirubin, n=17, 15, 17, 7, 10 -1.1  (2.33) -0.1  (4.04) -0.8  (3.60) 0.3  (1.38) 1.0  (3.92)
12.Primary Outcome
Title Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hide Description Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 18 18 19 8 10
Mean (Standard Deviation)
Unit of Measure: Milligrams per liter (Mg/L)
-1.36  (3.837) 0.20  (1.015) -0.47  (3.500) -0.76  (2.123) -0.93  (2.965)
13.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
Hide Description SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP, 20 M, n=19, 19, 19, 8, 11 -1.1  (7.20) -0.6  (6.01) 1.5  (4.59) 0.2  (5.38) -5.2  (8.63)
SBP, 45 M, n=19, 19, 19, 8, 11 -1.1  (6.13) -0.5  (9.16) -2.6  (8.34) 1.0  (7.12) -3.5  (8.23)
SBP, 1 h, n=19, 19, 19, 8, 11 -1.0  (8.11) -0.6  (5.83) -1.7  (8.46) -3.1  (10.20) -4.8  (5.29)
SBP, 2 h, n=19, 19, 19, 8, 11 2.5  (7.77) -1.2  (9.23) 0.6  (11.16) 2.2  (7.73) -2.7  (6.43)
SBP, 3 h, n=19, 19, 19, 8, 11 -0.6  (7.58) 0.9  (9.75) 2.6  (7.92) 4.7  (8.68) -0.1  (5.60)
SBP, 4 h, n=19, 19, 19, 8, 11 1.1  (6.10) 0.3  (9.99) 0.7  (8.18) 2.2  (7.59) -0.1  (8.66)
SBP, 6 h, n=19, 19, 19, 8, 11 0.1  (9.41) -1.4  (10.21) -0.7  (9.35) 3.9  (9.82) -3.2  (9.75)
SBP, 24 h, n=19, 19, 19, 8, 11 0.4  (7.53) 0.0  (9.01) -1.8  (8.70) 3.5  (9.10) -5.3  (8.21)
DBP, 20 M, n=19, 19, 19, 8, 11 -1.9  (4.17) -0.9  (4.59) -0.6  (3.95) 1.3  (1.93) -4.5  (7.31)
DBP, 45 M, n=19, 19, 19, 8, 11 -1.9  (4.65) -0.1  (6.53) -3.2  (5.91) 0.9  (6.63) -3.8  (5.27)
DBP, 1 h, n=19, 19, 19, 8, 11 -2.2  (7.12) -1.0  (4.46) -2.3  (4.81) -0.1  (9.03) -6.5  (5.99)
DBP, 2 h, n=19, 19, 19, 8, 11 0.2  (6.65) 0.2  (7.21) -1.7  (5.73) 1.3  (6.35) -3.4  (8.15)
DBP, 3 h, n=19, 19, 19, 8, 11 -2.0  (7.32) -0.0  (5.94) -1.7  (5.62) 2.5  (5.10) -4.0  (7.35)
DBP, 4 h, n=19, 19, 19, 8, 11 -2.3  (5.05) -0.6  (5.15) -1.7  (5.33) 1.7  (5.08) -4.7  (7.76)
DBP, 6 h, n=19, 19, 19, 8, 11 -3.2  (7.03) -0.9  (6.05) -2.9  (5.05) -1.1  (5.61) -7.6  (7.13)
DBP, 24 h, n=19, 19, 19, 8, 11 0.6  (4.49) -0.5  (5.62) -1.4  (6.88) -0.1  (5.38) -4.1  (6.32)
14.Primary Outcome
Title Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
Hide Description Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Deviation)
Unit of Measure: Beats per minute(bpm)
20 M, n=19, 19, 19, 8, 11 -2.9  (4.49) 0.7  (6.60) 0.1  (5.58) 2.2  (6.67) -2.4  (3.62)
45 M, n=19, 19, 19, 8, 11 0.3  (6.70) -0.2  (5.51) 0.3  (5.49) 4.0  (7.49) -1.9  (6.70)
1 h, n=19, 19, 19, 8, 11 -0.9  (5.33) -2.1  (5.92) 0.7  (6.74) 1.7  (5.36) -2.2  (5.59)
2 h, n=19, 19, 19, 8, 11 1.6  (7.41) 3.0  (11.76) 3.3  (8.34) 3.0  (7.00) -0.1  (7.46)
3 h, n=19, 19, 19, 8, 11 1.7  (7.06) 6.2  (13.76) 0.7  (8.09) 2.2  (6.84) 0.4  (5.43)
4 h, n=19, 19, 19, 8, 11 0.1  (6.57) 4.8  (13.87) 2.0  (6.40) 0.7  (7.72) 0.1  (6.10)
6 h, n=19, 19, 19, 8, 11 5.7  (10.31) 2.1  (14.37) 6.0  (9.32) 7.4  (11.35) 3.6  (8.40)
24 h, n=19, 19, 19, 8, 11 1.9  (9.39) 0.4  (9.05) 0.2  (6.19) 0.3  (11.35) -0.2  (7.91)
15.Primary Outcome
Title Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
Hide Description ECG parameters [PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
PR, 20 min, n=19, 19, 19, 8, 11 -7.3  (17.172) -1.4  (15.486) 1.0  (8.650) 0.5  (11.295) -8.9  (15.095)
PR, 45 min, n=19, 19, 19, 8, 10 -2.7  (7.846) -3.7  (15.106) 1.3  (13.588) -4.5  (12.912) -4.7  (11.038)
PR, 1 h, n=19, 19, 19, 8, 11 -2.8  (17.926) -2.7  (14.946) -1.7  (9.511) 4.3  (19.070) -3.3  (12.014)
PR, 2 h, n=19, 19, 19, 8, 11 -3.3  (12.978) -1.1  (11.047) -0.1  (13.800) -10.1  (44.279) 2.8  (15.513)
PR, 3 h, n=19, 19, 19, 8, 11 0.1  (12.837) -3.1  (15.130) 1.5  (10.602) 2.8  (20.863) -3.3  (12.741)
PR, 4 h, n=19, 19, 19, 8, 11 -3.0  (13.613) -1.7  (14.909) 1.5  (11.102) 16.98  (25.887) -2.5  (14.057)
PR, 6 h, n=18, 19, 19, 8, 11 -4.0  (10.157) 0.5  (15.174) -2.1  (9.437) 23.59  (21.544) 3.5  (11.536)
PR, 24 h, n=19, 19, 18, 8, 11 -1.4  (18.636) -1.6  (17.618) 0.4  (9.101) 27.07  (20.769) 2.1  (19.400)
QRS, 20 min, n=19, 19, 19, 8, 11 -1.9  (5.031) -1.0  (3.886) 0.6  (2.150) 1.0  (4.719) 1.4  (4.222)
QRS, 45 min, n=19, 19, 19, 8, 10 -1.6  (4.789) 0.2  (3.928) 0.2  (3.534) 0.0  (2.156) 0.1  (4.601)
QRS, 1 h, n=19, 19, 19, 8, 11 -2.0  (5.562) -0.9  (4.449) -0.2  (2.155) 2.7  (4.714) 1.0  (4.958)
QRS, 2 h, n=19, 19, 19, 8, 11 0.9  (5.393) -0.3  (3.888) 0.7  (4.579) 1.2  (1.265) -1.0  (6.513)
QRS, 3 h, n=19, 19, 19, 8, 11 0.3  (6.324) 1.2  (5.194) 0.3  (3.045) 0.9  (1.389) 0.6  (4.670)
QRS, 4 h, n=19, 19, 19, 8, 11 -1.0  (4.812) -0.9  (3.961) 1.0  (4.937) 1.0  (4.759) 1.7  (3.666)
QRS, 6 h, n=19, 19, 19, 8, 11 -1.0  (5.156) -0.1  (4.485) -0.0  (5.145) 0.1  (4.254) 2.0  (4.177)
QRS, 24 h, n=19, 19, 18, 8, 11 -1.4  (6.090) -1.5  (3.736) 0.7  (2.923) -0.0  (4.783) -0.5  (5.546)
RR, 20 min, n=19, 19, 19, 8, 11 48.9  (57.110) -9.0  (75.077) 3.9  (73.786) -29.2  (123.015) 4.7  (31.266)
RR, 45 min, n=19, 19, 19, 8, 10 5.6  (96.803) 9.1  (65.366) -5.7  (81.079) -73.0  (130.999) 4.0  (69.539)
RR, 1 h, n=19, 19, 19, 8, 11 29.8  (91.489) 39.9  (65.636) -3.7  (84.143) -29.1  (101.900) 11.3  (66.621)
RR, 2 h, n=19, 19, 19, 8, 11 -0.3  (108.528) -25.1  (153.206) -24.2  (127.159) -29.3  (105.815) -15.3  (90.415)
RR, 3 h, n=19, 19, 19, 8, 11 -12.7  (95.030) -55.0  (175.742) 5.6  (129.790) -35.7  (112.038) 13.1  (78.368)
RR, 4 h, n=19, 19, 19, 8, 11 -21.9  (86.948) -54.7  (173.646) -24.6  (85.316) -17.9  (97.684) 7.3  (94.243)
RR, 6 h, n=19, 19, 19, 8, 11 -61.0  (125.922) -23.2  (183.705) -64.1  (127.976) -106.1  (160.044) -45.5  (71.133)
RR, 24 h, n=19, 19, 18, 8, 11 -4.7  (108.355) 10.5  (95.865) 6.0  (103.940) -1.6  (76.068) -18.8  (81.880)
QT, 20 min, n=19, 19, 19, 8, 11 4.8  (15.094) -7.8  (13.891) -1.7  (9.306) 2.2  (18.150) -2.7  (24.051)
QT, 45 min, n=19, 19, 19, 8, 10 5.6  (15.245) -0.8  (12.037) -0.1  (11.856) 2.1  (8.750) 0.3  (17.997)
QT, 1 h, n=19, 19, 19, 8, 11 5.1  (14.820) 1.3  (13.453) 0.5  (13.096) 2.6  (14.876) -0.1  (23.941)
QT, 2 h, n=19, 19, 19, 8, 11 -4.4  (19.879) -9.2  (19.465) -5.6  (18.786) -10.5  (15.296) -0.7  (15.403)
QT, 3 h, n=19, 19, 19, 8, 11 -5.2  (21.154) -12.4  (28.408) 0.8  (18.469) -10.8  (15.253) -1.6  (15.403)
QT, 4 h, n=19, 19, 19, 8, 11 -7.1  (27.773) -16.6  (29.661) -6.3  (14.699) -5.0  (16.399) -0.9  (16.693)
QT, 6 h, n=19, 19, 19, 8, 11 -17.4  (22.329) -14.1  (26.540) -16.9  (20.348) -20.0  (22.842) -8.6  (11.990)
QT, 24 h, n=19, 19, 18, 8, 11 -9.3  (39.366) -4.8  (19.461) 1.1  (30.186) -0.3  (14.331) -1.1  (17.099)
QTc(B), 20 min, n=19, 19, 19, 8, 11 -5.6  (10.206) -5.7  (18.465) -2.5  (13.058) 7.6  (24.453) -4.8  (27.410)
QTc(B), 45 min, n=19, 19, 19, 8, 10 4.5  (21.312) -2.8  (13.737) 0.9  (13.972) 18.5  (20.184) -1.8  (24.471)
QTc(B), 1 h, n=19, 19, 19, 8, 11 -0.9  (19.298) -7.5  (15.779) 1.2  (12.743) 7.9  (11.202) -3.8  (30.201)
QTc(B), 2 h, n=19, 19, 19, 8, 11 -4.3  (16.691) -3.9  (18.963) 0.0  (16.015) -4.4  (22.214) 2.1  (17.456)
QTc(B), 3 h, n=19, 19, 19, 8, 11 -1.8  (20.177) 0.0  (19.550) 0.4  (20.161) -3.8  (17.665) -3.9  (13.908)
QTc(B), 4 h, n=19, 19, 19, 8, 11 -0.6  (30.768) -4.4  (13.490) -1.3  (11.909) -1.5  (14.136) -1.6  (11.578)
QTc(B), 6 h, n=19, 19, 19, 8, 11 -3.9  (16.976) -9.3  (18.612) -2.9  (15.326) 3.4  (12.821) 2.0  (10.667)
QTc(B), 24 h, n=19, 19, 18, 8, 11 -9.0  (32.387) -7.1  (15.386) -0.2  (14.676) 0.3  (9.022) 3.8  (18.294)
QTc(F), 20 min, n=19, 19, 18, 8, 11 -2.0  (10.761) -6.5  (14.867) -2.2  (9.227) 5.9  (19.428) -4.0  (26.022)
QTc(F), 45 min, n=19, 19, 19, 8, 10 4.9  (16.508) -2.1  (11.430) 0.6  (9.920) 13.0  (12.102) -0.9  (20.795)
QTc(F), 1 h, n=19, 19, 19, 8, 11 1.1  (15.088) -4.4  (13.387) 1.0  (9.193) 6.2  (8.626) -2.4  (26.900)
QTc(F), 2 h, n=19, 19, 19, 8, 11 -4.4  (14.122) -5.8  (10.606) -2.0  (11.272) -6.5  (16.576) 1.2  (13.750)
QTc(F), 3 h, n=19, 19, 19, 8, 11 -3.1  (17.341) -4.4  (13.383) 0.5  (14.498) -6.2  (11.842) -3.2  (10.836)
QTc(F), 4 h, n=19, 19, 19, 8, 11 -3.1  (28.679) -8.8  (10.344) -3.0  (9.373) -2.7  (11.136) 10.836  (8.648)
QTc(F), 6 h, n=19, 19, 19, 8, 11 -8.7  (13.113) -11.1  (10.871) -7.8  (10.278) -4.7  (5.959) -1.7  (6.561)
QTc(F), 24 h, n=19, 19, 18, 8, 11 -9.2  (33.102) -6.4  (13.364) 0.0  (17.882) 0.0  (0.0) 2.0  (15.496)
16.Secondary Outcome
Title Mean FEV1 Over 23 and 24 Hours After Dosing
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 20 19 6 12
Mean (Standard Error)
Unit of Measure: Liters
1.432  (0.0402) 1.622  (0.0431) 1.638  (0.0415) 1.642  (0.0650) 1.569  (0.0501)
17.Secondary Outcome
Title Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
Hide Description QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Error)
Unit of Measure: Milliseconds (msec)
WM QTcB 419.68  (2.150) 419.56  (2.378) 424.18  (2.230) 422.36  (3.517) 419.70  (2.714)
Max QTcB 439.37  (3.714) 437.06  (4.104) 434.62  (3.850) 438.14  (6.059) 436.75  (4.681)
WM QTcF, 409.13  (1.696) 408.31  (1.898) 412.99  (1.760) 409.50  (2.842) 409.82  (2.163)
Max QTcF 425.34  (2.900) 421.73  (3.286) 422.55  (3.025) 422.41  (5.000) 422.99  (3.766)
18.Secondary Outcome
Title Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate
Hide Description Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Error)
Unit of Measure: Beats per minute
WM Heart rate 71.12  (1.320) 71.76  (1.473) 71.57  (1.377) 73.50  (2.179) 71.22  (1.734)
Max Heart rate 77.88  (1.784) 79.95  (1.948) 76.13  (1.845) 77.77  (2.764) 77.16  (2.248)
19.Secondary Outcome
Title Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
Hide Description Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 19 19 19 8 11
Mean (Standard Error)
Unit of Measure: Millimeters of mercury
WM SBP 126.92  (1.223) 126.28  (1.388) 127.82  (1.284) 128.99  (2.146) 125.10  (1.621)
Max SBP 133.23  (1.521) 133.06  (1.714) 133.91  (1.591) 135.24  (2.625) 131.13  (1.994)
WM DBP 80.36  (1.017) 79.74  (1.133) 80.04  (1.056) 83.46  (1.721) 77.46  (1.321)
Max DBP 76.13  (1.147) 75.08  (1.272) 76.30  (1.189) 79.92  (1.917) 71.63  (1.478)
20.Secondary Outcome
Title Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
Hide Description Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter [mL]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 17 20 19 6 12
Mean (Standard Error)
Unit of Measure: Millimoles per liter (mmol/L)
WM Glucose, n=16,18,19,6,10 5.94  (0.204) 5.86  (0.227) 5.95  (0.200) 6.25  (0.345) 5.71  (0.251)
Max Glucose, n=17, 20, 19, 6,10 6.73  (0.342) 6.61  (0.370) 6.65  (0.342) 6.99  (0.608) 6.09  (0.436)
WM Potassium, n=15, 16, 17, 5,12 4.29  (0.058) 4.29  (0.067) 4.14  (0.057) 4.22  (0.102) 4.27  (0.073)
Min Potassium, n=16, 20, 18, 6,12 4.02  (0.052) 4.03  (0.053) 3.97  (0.052) 4.08  (0.082) 4.08  (0.065)
21.Secondary Outcome
Title AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Hide Description Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time Frame Baseline and Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 0 17 19 8 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms.Hour/milliliter (pg.hr/mL)
GW642444, AUC(0-t), n=0, 17, 19, 8, 10
56.49
(86.2%)
222.36
(96.5%)
572.99
(45.3%)
98.13
(0.782%)
GW64244, AUC(0-1), n=0, 11, 18, 8, 10
58.01
(25.4%)
106.31
(44.5%)
196.24
(23.9%)
54.85
(28.3%)
GI179710, AUC (0-t), n=0, 0, 0, 1, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
GW630200, AUC(0-t), n=0, 0, 0, 0, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
GSK932009, AUC(0-t), n=0, 0, 0, 0, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Insufficient data to define due to assay censoring.
22.Secondary Outcome
Title Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Hide Description Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time Frame Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 0 20 19 8 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms/milliliter (pg/mL)
GW642444,n=0, 20, 19, 8, 12
78.16
(43.9%)
150.60
(53.1%)
259.96
(22.2%)
73.70
(35.7%)
GI179710,n=0, 0, 4, 7, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
GW630200, n=0, 0, 0, 0, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
GSK932009, n=0, 0, 0, 0, 0
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Insufficient data to define due to assay censoring.
23.Secondary Outcome
Title Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Hide Description Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time Frame Day 1 of each treatment period (up to Study Day 54)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description:
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
Overall Number of Participants Analyzed 0 20 19 8 12
Median (Full Range)
Unit of Measure: Hours
GW642444,n=0, 20, 19, 8, 12
0.175
(0.03 to 2.00)
0.200
(0.08 to 1.00)
0.425
(0.15 to 1.03)
0.500
(0.20 to 2.07)
GI179710,n=0, 0, 4, 7, 0
NA [1] 
(NA to NA)
0.140
(0.0 to 0.18)
0.170
(0.07 to 0.33)
NA [1] 
(NA to NA)
GW630200, n=0, 0, 0, 0, 0
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
GSK932009, n=0, 0, 0, 0, 0
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Insufficient data to define due to assay censoring.
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Study Day 60).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
 
Arm/Group Title Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Hide Arm/Group Description Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
All-Cause Mortality
Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/19 (0.00%)   0/8 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo GW642444M 25 µg GW642444M 50 µg GW642444M 100 µg GW642444H 100 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/19 (10.53%)   1/20 (5.00%)   2/19 (10.53%)   0/8 (0.00%)   0/12 (0.00%) 
Infections and infestations           
Nasopharyngitis  1  1/19 (5.26%)  0/20 (0.00%)  1/19 (5.26%)  0/8 (0.00%)  0/12 (0.00%) 
Nervous system disorders           
Headache  1  1/19 (5.26%)  1/20 (5.00%)  1/19 (5.26%)  0/8 (0.00%)  0/12 (0.00%) 
Dysgeusia  1  0/19 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  0/8 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519376     History of Changes
Other Study ID Numbers: B2C110165
First Submitted: August 21, 2007
First Posted: August 22, 2007
Results First Submitted: June 12, 2013
Results First Posted: December 30, 2013
Last Update Posted: March 23, 2017