Trial Outcomes & Findings for A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients. (NCT NCT00519376)
NCT ID: NCT00519376
Last Updated: 2017-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)
Results posted on
2017-03-23
Participant Flow
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.
Participant milestones
| Measure |
Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg
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).
|
Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg
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).
|
Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg
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).
|
Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB
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).
|
Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg
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).
|
Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg
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).
|
Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg
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).
|
Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg
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).
|
Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg
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).
|
Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB
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).
|
Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg
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).
|
Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg
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).
|
Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB
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).
|
Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg
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).
|
Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg
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).
|
Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB
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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Washout Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Washout Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Treatment Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Washout Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
2
|
2
|
2
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Treatment Period 4
COMPLETED
|
2
|
2
|
1
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg
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).
|
Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg
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).
|
Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg
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).
|
Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB
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).
|
Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg
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).
|
Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg
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).
|
Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg
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).
|
Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg
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).
|
Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg
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).
|
Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB
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).
|
Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg
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).
|
Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg
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).
|
Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB
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).
|
Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg
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).
|
Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg
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).
|
Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB
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).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 2
Unable Evaluate Cardiovascular Endpoints
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 4
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.
Baseline characteristics by cohort
| Measure |
GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq
n=20 Participants
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).
|
|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)Population: All Subjects Population: all participants who received at least one dose of study medication
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=12 Participants
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).
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Any AE
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
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
Basophils, n=19, 20, 19, 8, 11
|
0.004 10^9 cells per liter (GI/L)
Standard Deviation 0.0154
|
0.001 10^9 cells per liter (GI/L)
Standard Deviation 0.0168
|
0.001 10^9 cells per liter (GI/L)
Standard Deviation 0.0133
|
0.004 10^9 cells per liter (GI/L)
Standard Deviation 0.0185
|
-0.004 10^9 cells per liter (GI/L)
Standard Deviation 0.0211
|
|
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
Eosinophils, n=19, 20, 19, 8, 11
|
0.003 10^9 cells per liter (GI/L)
Standard Deviation 0.1771
|
-0.045 10^9 cells per liter (GI/L)
Standard Deviation 0.0707
|
-0.023 10^9 cells per liter (GI/L)
Standard Deviation 0.0921
|
-0.031 10^9 cells per liter (GI/L)
Standard Deviation 0.0895
|
-0.002 10^9 cells per liter (GI/L)
Standard Deviation 0.0637
|
|
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
Lymphocytes, n=19, 20, 19, 8, 11
|
0.068 10^9 cells per liter (GI/L)
Standard Deviation 0.4094
|
0.021 10^9 cells per liter (GI/L)
Standard Deviation 0.3719
|
-0.126 10^9 cells per liter (GI/L)
Standard Deviation 0.2608
|
-0.146 10^9 cells per liter (GI/L)
Standard Deviation 0.4055
|
-0.116 10^9 cells per liter (GI/L)
Standard Deviation 0.3261
|
|
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
Monocytes, n=19, 20, 19, 8, 11
|
0.006 10^9 cells per liter (GI/L)
Standard Deviation 0.1323
|
-0.027 10^9 cells per liter (GI/L)
Standard Deviation 0.1390
|
0.007 10^9 cells per liter (GI/L)
Standard Deviation 0.0917
|
-0.018 10^9 cells per liter (GI/L)
Standard Deviation 0.1331
|
0.025 10^9 cells per liter (GI/L)
Standard Deviation 0.1347
|
|
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
Total Neutrophils, n=19, 20, 19, 8, 11
|
-0.100 10^9 cells per liter (GI/L)
Standard Deviation 0.6174
|
0.188 10^9 cells per liter (GI/L)
Standard Deviation 0.9814
|
0.343 10^9 cells per liter (GI/L)
Standard Deviation 0.9674
|
0.201 10^9 cells per liter (GI/L)
Standard Deviation 0.6165
|
-0.021 10^9 cells per liter (GI/L)
Standard Deviation 0.7415
|
|
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
Platelet count, n=19, 20, 19, 8, 11
|
5.0 10^9 cells per liter (GI/L)
Standard Deviation 16.16
|
8.2 10^9 cells per liter (GI/L)
Standard Deviation 18.38
|
8.5 10^9 cells per liter (GI/L)
Standard Deviation 15.33
|
9.5 10^9 cells per liter (GI/L)
Standard Deviation 13.72
|
-1.1 10^9 cells per liter (GI/L)
Standard Deviation 10.82
|
|
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
WBC, n=19, 20, 19, 8, 11
|
-0.02 10^9 cells per liter (GI/L)
Standard Deviation 0.807
|
0.14 10^9 cells per liter (GI/L)
Standard Deviation 1.215
|
0.20 10^9 cells per liter (GI/L)
Standard Deviation 1.029
|
0.04 10^9 cells per liter (GI/L)
Standard Deviation 1.094
|
-0.12 10^9 cells per liter (GI/L)
Standard Deviation 0.774
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period
Hemoglobin, n=19, 20, 19, 8, 11
|
-0.4 Grams per liter (g/L)
Standard Deviation 6.21
|
-1.2 Grams per liter (g/L)
Standard Deviation 6.41
|
-0.5 Grams per liter (g/L)
Standard Deviation 4.02
|
-3.0 Grams per liter (g/L)
Standard Deviation 4.21
|
0.8 Grams per liter (g/L)
Standard Deviation 5.47
|
|
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period
MCHC, n=19, 20, 19, 8, 11
|
-3.5 Grams per liter (g/L)
Standard Deviation 5.23
|
-5.8 Grams per liter (g/L)
Standard Deviation 22.66
|
1.7 Grams per liter (g/L)
Standard Deviation 5.58
|
5.3 Grams per liter (g/L)
Standard Deviation 3.65
|
-0.8 Grams per liter (g/L)
Standard Deviation 6.27
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period
Reticulocytes, n=19, 19, 19, 8, 11
|
-0.00714 10^12 cells per liter (TI/L)
Standard Deviation 0.021416
|
-0.00065 10^12 cells per liter (TI/L)
Standard Deviation 0.019905
|
0.00208 10^12 cells per liter (TI/L)
Standard Deviation 0.017391
|
0.00905 10^12 cells per liter (TI/L)
Standard Deviation 0.016387
|
0.00094 10^12 cells per liter (TI/L)
Standard Deviation 0.012676
|
|
Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period
RBC, n=19, 20, 19, 8, 11
|
0.00 10^12 cells per liter (TI/L)
Standard Deviation 0.194
|
0.01 10^12 cells per liter (TI/L)
Standard Deviation 0.193
|
-0.01 10^12 cells per liter (TI/L)
Standard Deviation 0.137
|
-0.11 10^12 cells per liter (TI/L)
Standard Deviation 0.173
|
0.05 10^12 cells per liter (TI/L)
Standard Deviation 0.186
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period
|
0.0044 Proportion of 1.0
Standard Deviation 0.02025
|
-0.0024 Proportion of 1.0
Standard Deviation 0.02132
|
-0.0018 Proportion of 1.0
Standard Deviation 0.01674
|
-0.0161 Proportion of 1.0
Standard Deviation 0.01408
|
0.0036 Proportion of 1.0
Standard Deviation 0.02025
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period
|
0.6 10^15 femtoliters (fL) per cell
Standard Deviation 1.67
|
-0.2 10^15 femtoliters (fL) per cell
Standard Deviation 2.09
|
-0.2 10^15 femtoliters (fL) per cell
Standard Deviation 1.96
|
-1.0 10^15 femtoliters (fL) per cell
Standard Deviation 0.76
|
-0.5 10^15 femtoliters (fL) per cell
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period
|
-0.11 10^12 picograms (pg) per cell
Standard Deviation 0.403
|
-0.22 10^12 picograms (pg) per cell
Standard Deviation 0.465
|
0.24 10^12 picograms (pg) per cell
Standard Deviation 0.581
|
0.14 10^12 picograms (pg) per cell
Standard Deviation 0.342
|
-0.21 10^12 picograms (pg) per cell
Standard Deviation 0.528
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=15 Participants
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).
|
GW642444M 50 µg
n=17 Participants
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).
|
GW642444M 100 µg
n=7 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
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
GGT, n=17, 15, 17, 7, 10
|
-2.0 International units per liter (IU/L)
Standard Deviation 2.37
|
-0.9 International units per liter (IU/L)
Standard Deviation 3.99
|
-0.5 International units per liter (IU/L)
Standard Deviation 5.06
|
-1.6 International units per liter (IU/L)
Standard Deviation 2.88
|
0.5 International units per liter (IU/L)
Standard Deviation 5.21
|
|
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
ALT, n=17, 15, 17, 7, 10
|
0.1 International units per liter (IU/L)
Standard Deviation 3.89
|
-0.5 International units per liter (IU/L)
Standard Deviation 2.00
|
1.1 International units per liter (IU/L)
Standard Deviation 2.75
|
-0.6 International units per liter (IU/L)
Standard Deviation 1.51
|
1.0 International units per liter (IU/L)
Standard Deviation 4.08
|
|
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
ALP, n=17, 15, 17, 7, 10
|
0.4 International units per liter (IU/L)
Standard Deviation 10.05
|
1.6 International units per liter (IU/L)
Standard Deviation 4.90
|
0.6 International units per liter (IU/L)
Standard Deviation 5.93
|
-0.4 International units per liter (IU/L)
Standard Deviation 2.37
|
1.2 International units per liter (IU/L)
Standard Deviation 6.91
|
|
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
AST, n=17, 13, 17, 6, 9
|
-0.1 International units per liter (IU/L)
Standard Deviation 5.46
|
-0.6 International units per liter (IU/L)
Standard Deviation 2.87
|
-1.6 International units per liter (IU/L)
Standard Deviation 2.69
|
-1.7 International units per liter (IU/L)
Standard Deviation 1.03
|
2.1 International units per liter (IU/L)
Standard Deviation 5.84
|
|
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
CK n=17, 15, 17, 7, 10
|
-18.1 International units per liter (IU/L)
Standard Deviation 29.90
|
-20.5 International units per liter (IU/L)
Standard Deviation 36.07
|
-38.1 International units per liter (IU/L)
Standard Deviation 69.67
|
-3.1 International units per liter (IU/L)
Standard Deviation 15.99
|
-19.9 International units per liter (IU/L)
Standard Deviation 20.89
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=15 Participants
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).
|
GW642444M 50 µg
n=17 Participants
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).
|
GW642444M 100 µg
n=7 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Total protein, n=17, 15, 17, 7, 10
|
-1.7 Grams per liter
Standard Deviation 4.22
|
-0.5 Grams per liter
Standard Deviation 2.59
|
0.1 Grams per liter
Standard Deviation 2.34
|
-0.7 Grams per liter
Standard Deviation 3.40
|
0.8 Grams per liter
Standard Deviation 1.55
|
|
Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Albumin, n=17, 15, 17, 7, 10
|
-0.9 Grams per liter
Standard Deviation 2.30
|
-0.1 Grams per liter
Standard Deviation 1.85
|
-0.2 Grams per liter
Standard Deviation 1.51
|
-0.9 Grams per liter
Standard Deviation 1.95
|
0.1 Grams per liter
Standard Deviation 0.88
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=15 Participants
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).
|
GW642444M 50 µg
n=17 Participants
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).
|
GW642444M 100 µg
n=7 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Sodium, n=17, 15, 17, 7, 10
|
0.9 Millimoles per liter (mmol/L)
Standard Deviation 2.03
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 1.83
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 1.41
|
0.0 Millimoles per liter (mmol/L)
Standard Deviation 1.15
|
0.9 Millimoles per liter (mmol/L)
Standard Deviation 1.79
|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Triglyceride, n=17, 15, 17, 7, 10
|
-0.106 Millimoles per liter (mmol/L)
Standard Deviation 0.4625
|
0.024 Millimoles per liter (mmol/L)
Standard Deviation 0.5789
|
-0.015 Millimoles per liter (mmol/L)
Standard Deviation 0.3800
|
-0.300 Millimoles per liter (mmol/L)
Standard Deviation 0.5812
|
0.142 Millimoles per liter (mmol/L)
Standard Deviation 0.2629
|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Urea, n=17, 15, 17, 7, 10
|
0.29 Millimoles per liter (mmol/L)
Standard Deviation 1.092
|
-0.17 Millimoles per liter (mmol/L)
Standard Deviation 0.964
|
-0.38 Millimoles per liter (mmol/L)
Standard Deviation 1.109
|
-0.17 Millimoles per liter (mmol/L)
Standard Deviation 0.427
|
0.20 Millimoles per liter (mmol/L)
Standard Deviation 0.918
|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Cholesterol, n=17, 15, 17, 7, 10
|
-0.085 Millimoles per liter (mmol/L)
Standard Deviation 0.3416
|
0.121 Millimoles per liter (mmol/L)
Standard Deviation 0.3764
|
0.032 Millimoles per liter (mmol/L)
Standard Deviation 1.2588
|
-0.251 Millimoles per liter (mmol/L)
Standard Deviation 0.5630
|
0.082 Millimoles per liter (mmol/L)
Standard Deviation 0.2447
|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Chloride, n=17, 15, 17, 7, 10
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.65
|
0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.80
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.31
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 1.70
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 1.43
|
|
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Potassium, n=17, 13, 17, 6, 9
|
0.12 Millimoles per liter (mmol/L)
Standard Deviation 0.263
|
0.14 Millimoles per liter (mmol/L)
Standard Deviation 0.384
|
0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.374
|
0.10 Millimoles per liter (mmol/L)
Standard Deviation 0.358
|
0.16 Millimoles per liter (mmol/L)
Standard Deviation 0.305
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=15 Participants
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).
|
GW642444M 50 µg
n=17 Participants
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).
|
GW642444M 100 µg
n=7 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period
Creatinine, n=17, 15, 17, 7, 10
|
3.5 Micromoles per liter (µmol/L)
Standard Deviation 5.96
|
4.9 Micromoles per liter (µmol/L)
Standard Deviation 5.62
|
4.9 Micromoles per liter (µmol/L)
Standard Deviation 6.62
|
1.0 Micromoles per liter (µmol/L)
Standard Deviation 5.07
|
1.5 Micromoles per liter (µmol/L)
Standard Deviation 5.28
|
|
Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period
Total Bilirubin, n=17, 15, 17, 7, 10
|
-1.1 Micromoles per liter (µmol/L)
Standard Deviation 2.33
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 4.04
|
-0.8 Micromoles per liter (µmol/L)
Standard Deviation 3.60
|
0.3 Micromoles per liter (µmol/L)
Standard Deviation 1.38
|
1.0 Micromoles per liter (µmol/L)
Standard Deviation 3.92
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=18 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
|
-1.36 Milligrams per liter (Mg/L)
Standard Deviation 3.837
|
0.20 Milligrams per liter (Mg/L)
Standard Deviation 1.015
|
-0.47 Milligrams per liter (Mg/L)
Standard Deviation 3.500
|
-0.76 Milligrams per liter (Mg/L)
Standard Deviation 2.123
|
-0.93 Milligrams per liter (Mg/L)
Standard Deviation 2.965
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 1 h, n=19, 19, 19, 8, 11
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 8.11
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 5.83
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 8.46
|
-3.1 Millimeters of mercury (mmHg)
Standard Deviation 10.20
|
-4.8 Millimeters of mercury (mmHg)
Standard Deviation 5.29
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 20 M, n=19, 19, 19, 8, 11
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 7.20
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 6.01
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 4.59
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 5.38
|
-5.2 Millimeters of mercury (mmHg)
Standard Deviation 8.63
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 45 M, n=19, 19, 19, 8, 11
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 6.13
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 9.16
|
-2.6 Millimeters of mercury (mmHg)
Standard Deviation 8.34
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 7.12
|
-3.5 Millimeters of mercury (mmHg)
Standard Deviation 8.23
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 2 h, n=19, 19, 19, 8, 11
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 7.77
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 9.23
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 11.16
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 7.73
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 6.43
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 3 h, n=19, 19, 19, 8, 11
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.58
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 9.75
|
2.6 Millimeters of mercury (mmHg)
Standard Deviation 7.92
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 8.68
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 5.60
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 6 h, n=19, 19, 19, 8, 11
|
0.1 Millimeters of mercury (mmHg)
Standard Deviation 9.41
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 10.21
|
-0.7 Millimeters of mercury (mmHg)
Standard Deviation 9.35
|
3.9 Millimeters of mercury (mmHg)
Standard Deviation 9.82
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 9.75
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 20 M, n=19, 19, 19, 8, 11
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 4.17
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 4.59
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 3.95
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 1.93
|
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 7.31
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 45 M, n=19, 19, 19, 8, 11
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 4.65
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 6.53
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 5.91
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 6.63
|
-3.8 Millimeters of mercury (mmHg)
Standard Deviation 5.27
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 1 h, n=19, 19, 19, 8, 11
|
-2.2 Millimeters of mercury (mmHg)
Standard Deviation 7.12
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 4.46
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 4.81
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 9.03
|
-6.5 Millimeters of mercury (mmHg)
Standard Deviation 5.99
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 2 h, n=19, 19, 19, 8, 11
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 6.65
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 7.21
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 5.73
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 6.35
|
-3.4 Millimeters of mercury (mmHg)
Standard Deviation 8.15
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 3 h, n=19, 19, 19, 8, 11
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 7.32
|
-0.0 Millimeters of mercury (mmHg)
Standard Deviation 5.94
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 5.62
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 5.10
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation 7.35
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 4 h, n=19, 19, 19, 8, 11
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 5.05
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 5.15
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 5.33
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 5.08
|
-4.7 Millimeters of mercury (mmHg)
Standard Deviation 7.76
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 24 h, n=19, 19, 19, 8, 11
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 4.49
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 5.62
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 6.88
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 5.38
|
-4.1 Millimeters of mercury (mmHg)
Standard Deviation 6.32
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
DBP, 6 h, n=19, 19, 19, 8, 11
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 7.03
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 6.05
|
-2.9 Millimeters of mercury (mmHg)
Standard Deviation 5.05
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 5.61
|
-7.6 Millimeters of mercury (mmHg)
Standard Deviation 7.13
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 4 h, n=19, 19, 19, 8, 11
|
1.1 Millimeters of mercury (mmHg)
Standard Deviation 6.10
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 9.99
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 8.18
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 7.59
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 8.66
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP, 24 h, n=19, 19, 19, 8, 11
|
0.4 Millimeters of mercury (mmHg)
Standard Deviation 7.53
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 9.01
|
-1.8 Millimeters of mercury (mmHg)
Standard Deviation 8.70
|
3.5 Millimeters of mercury (mmHg)
Standard Deviation 9.10
|
-5.3 Millimeters of mercury (mmHg)
Standard Deviation 8.21
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
24 h, n=19, 19, 19, 8, 11
|
1.9 Beats per minute(bpm)
Standard Deviation 9.39
|
0.4 Beats per minute(bpm)
Standard Deviation 9.05
|
0.2 Beats per minute(bpm)
Standard Deviation 6.19
|
0.3 Beats per minute(bpm)
Standard Deviation 11.35
|
-0.2 Beats per minute(bpm)
Standard Deviation 7.91
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
20 M, n=19, 19, 19, 8, 11
|
-2.9 Beats per minute(bpm)
Standard Deviation 4.49
|
0.7 Beats per minute(bpm)
Standard Deviation 6.60
|
0.1 Beats per minute(bpm)
Standard Deviation 5.58
|
2.2 Beats per minute(bpm)
Standard Deviation 6.67
|
-2.4 Beats per minute(bpm)
Standard Deviation 3.62
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
45 M, n=19, 19, 19, 8, 11
|
0.3 Beats per minute(bpm)
Standard Deviation 6.70
|
-0.2 Beats per minute(bpm)
Standard Deviation 5.51
|
0.3 Beats per minute(bpm)
Standard Deviation 5.49
|
4.0 Beats per minute(bpm)
Standard Deviation 7.49
|
-1.9 Beats per minute(bpm)
Standard Deviation 6.70
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
1 h, n=19, 19, 19, 8, 11
|
-0.9 Beats per minute(bpm)
Standard Deviation 5.33
|
-2.1 Beats per minute(bpm)
Standard Deviation 5.92
|
0.7 Beats per minute(bpm)
Standard Deviation 6.74
|
1.7 Beats per minute(bpm)
Standard Deviation 5.36
|
-2.2 Beats per minute(bpm)
Standard Deviation 5.59
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
2 h, n=19, 19, 19, 8, 11
|
1.6 Beats per minute(bpm)
Standard Deviation 7.41
|
3.0 Beats per minute(bpm)
Standard Deviation 11.76
|
3.3 Beats per minute(bpm)
Standard Deviation 8.34
|
3.0 Beats per minute(bpm)
Standard Deviation 7.00
|
-0.1 Beats per minute(bpm)
Standard Deviation 7.46
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
3 h, n=19, 19, 19, 8, 11
|
1.7 Beats per minute(bpm)
Standard Deviation 7.06
|
6.2 Beats per minute(bpm)
Standard Deviation 13.76
|
0.7 Beats per minute(bpm)
Standard Deviation 8.09
|
2.2 Beats per minute(bpm)
Standard Deviation 6.84
|
0.4 Beats per minute(bpm)
Standard Deviation 5.43
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
4 h, n=19, 19, 19, 8, 11
|
0.1 Beats per minute(bpm)
Standard Deviation 6.57
|
4.8 Beats per minute(bpm)
Standard Deviation 13.87
|
2.0 Beats per minute(bpm)
Standard Deviation 6.40
|
0.7 Beats per minute(bpm)
Standard Deviation 7.72
|
0.1 Beats per minute(bpm)
Standard Deviation 6.10
|
|
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
6 h, n=19, 19, 19, 8, 11
|
5.7 Beats per minute(bpm)
Standard Deviation 10.31
|
2.1 Beats per minute(bpm)
Standard Deviation 14.37
|
6.0 Beats per minute(bpm)
Standard Deviation 9.32
|
7.4 Beats per minute(bpm)
Standard Deviation 11.35
|
3.6 Beats per minute(bpm)
Standard Deviation 8.40
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 6 h, n=19, 19, 19, 8, 11
|
-1.0 milliseconds (msec)
Standard Deviation 5.156
|
-0.1 milliseconds (msec)
Standard Deviation 4.485
|
-0.0 milliseconds (msec)
Standard Deviation 5.145
|
0.1 milliseconds (msec)
Standard Deviation 4.254
|
2.0 milliseconds (msec)
Standard Deviation 4.177
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 20 min, n=19, 19, 19, 8, 11
|
-7.3 milliseconds (msec)
Standard Deviation 17.172
|
-1.4 milliseconds (msec)
Standard Deviation 15.486
|
1.0 milliseconds (msec)
Standard Deviation 8.650
|
0.5 milliseconds (msec)
Standard Deviation 11.295
|
-8.9 milliseconds (msec)
Standard Deviation 15.095
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 45 min, n=19, 19, 19, 8, 10
|
-2.7 milliseconds (msec)
Standard Deviation 7.846
|
-3.7 milliseconds (msec)
Standard Deviation 15.106
|
1.3 milliseconds (msec)
Standard Deviation 13.588
|
-4.5 milliseconds (msec)
Standard Deviation 12.912
|
-4.7 milliseconds (msec)
Standard Deviation 11.038
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 1 h, n=19, 19, 19, 8, 11
|
-2.8 milliseconds (msec)
Standard Deviation 17.926
|
-2.7 milliseconds (msec)
Standard Deviation 14.946
|
-1.7 milliseconds (msec)
Standard Deviation 9.511
|
4.3 milliseconds (msec)
Standard Deviation 19.070
|
-3.3 milliseconds (msec)
Standard Deviation 12.014
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 2 h, n=19, 19, 19, 8, 11
|
-3.3 milliseconds (msec)
Standard Deviation 12.978
|
-1.1 milliseconds (msec)
Standard Deviation 11.047
|
-0.1 milliseconds (msec)
Standard Deviation 13.800
|
-10.1 milliseconds (msec)
Standard Deviation 44.279
|
2.8 milliseconds (msec)
Standard Deviation 15.513
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 3 h, n=19, 19, 19, 8, 11
|
0.1 milliseconds (msec)
Standard Deviation 12.837
|
-3.1 milliseconds (msec)
Standard Deviation 15.130
|
1.5 milliseconds (msec)
Standard Deviation 10.602
|
2.8 milliseconds (msec)
Standard Deviation 20.863
|
-3.3 milliseconds (msec)
Standard Deviation 12.741
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 4 h, n=19, 19, 19, 8, 11
|
-3.0 milliseconds (msec)
Standard Deviation 13.613
|
-1.7 milliseconds (msec)
Standard Deviation 14.909
|
1.5 milliseconds (msec)
Standard Deviation 11.102
|
16.98 milliseconds (msec)
Standard Deviation 25.887
|
-2.5 milliseconds (msec)
Standard Deviation 14.057
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 6 h, n=18, 19, 19, 8, 11
|
-4.0 milliseconds (msec)
Standard Deviation 10.157
|
0.5 milliseconds (msec)
Standard Deviation 15.174
|
-2.1 milliseconds (msec)
Standard Deviation 9.437
|
23.59 milliseconds (msec)
Standard Deviation 21.544
|
3.5 milliseconds (msec)
Standard Deviation 11.536
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
PR, 24 h, n=19, 19, 18, 8, 11
|
-1.4 milliseconds (msec)
Standard Deviation 18.636
|
-1.6 milliseconds (msec)
Standard Deviation 17.618
|
0.4 milliseconds (msec)
Standard Deviation 9.101
|
27.07 milliseconds (msec)
Standard Deviation 20.769
|
2.1 milliseconds (msec)
Standard Deviation 19.400
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 20 min, n=19, 19, 19, 8, 11
|
-1.9 milliseconds (msec)
Standard Deviation 5.031
|
-1.0 milliseconds (msec)
Standard Deviation 3.886
|
0.6 milliseconds (msec)
Standard Deviation 2.150
|
1.0 milliseconds (msec)
Standard Deviation 4.719
|
1.4 milliseconds (msec)
Standard Deviation 4.222
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 45 min, n=19, 19, 19, 8, 10
|
-1.6 milliseconds (msec)
Standard Deviation 4.789
|
0.2 milliseconds (msec)
Standard Deviation 3.928
|
0.2 milliseconds (msec)
Standard Deviation 3.534
|
0.0 milliseconds (msec)
Standard Deviation 2.156
|
0.1 milliseconds (msec)
Standard Deviation 4.601
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 1 h, n=19, 19, 19, 8, 11
|
-2.0 milliseconds (msec)
Standard Deviation 5.562
|
-0.9 milliseconds (msec)
Standard Deviation 4.449
|
-0.2 milliseconds (msec)
Standard Deviation 2.155
|
2.7 milliseconds (msec)
Standard Deviation 4.714
|
1.0 milliseconds (msec)
Standard Deviation 4.958
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 2 h, n=19, 19, 19, 8, 11
|
0.9 milliseconds (msec)
Standard Deviation 5.393
|
-0.3 milliseconds (msec)
Standard Deviation 3.888
|
0.7 milliseconds (msec)
Standard Deviation 4.579
|
1.2 milliseconds (msec)
Standard Deviation 1.265
|
-1.0 milliseconds (msec)
Standard Deviation 6.513
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 3 h, n=19, 19, 19, 8, 11
|
0.3 milliseconds (msec)
Standard Deviation 6.324
|
1.2 milliseconds (msec)
Standard Deviation 5.194
|
0.3 milliseconds (msec)
Standard Deviation 3.045
|
0.9 milliseconds (msec)
Standard Deviation 1.389
|
0.6 milliseconds (msec)
Standard Deviation 4.670
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 4 h, n=19, 19, 19, 8, 11
|
-1.0 milliseconds (msec)
Standard Deviation 4.812
|
-0.9 milliseconds (msec)
Standard Deviation 3.961
|
1.0 milliseconds (msec)
Standard Deviation 4.937
|
1.0 milliseconds (msec)
Standard Deviation 4.759
|
1.7 milliseconds (msec)
Standard Deviation 3.666
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QRS, 24 h, n=19, 19, 18, 8, 11
|
-1.4 milliseconds (msec)
Standard Deviation 6.090
|
-1.5 milliseconds (msec)
Standard Deviation 3.736
|
0.7 milliseconds (msec)
Standard Deviation 2.923
|
-0.0 milliseconds (msec)
Standard Deviation 4.783
|
-0.5 milliseconds (msec)
Standard Deviation 5.546
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 1 h, n=19, 19, 19, 8, 11
|
29.8 milliseconds (msec)
Standard Deviation 91.489
|
39.9 milliseconds (msec)
Standard Deviation 65.636
|
-3.7 milliseconds (msec)
Standard Deviation 84.143
|
-29.1 milliseconds (msec)
Standard Deviation 101.900
|
11.3 milliseconds (msec)
Standard Deviation 66.621
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 2 h, n=19, 19, 19, 8, 11
|
-0.3 milliseconds (msec)
Standard Deviation 108.528
|
-25.1 milliseconds (msec)
Standard Deviation 153.206
|
-24.2 milliseconds (msec)
Standard Deviation 127.159
|
-29.3 milliseconds (msec)
Standard Deviation 105.815
|
-15.3 milliseconds (msec)
Standard Deviation 90.415
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 3 h, n=19, 19, 19, 8, 11
|
-12.7 milliseconds (msec)
Standard Deviation 95.030
|
-55.0 milliseconds (msec)
Standard Deviation 175.742
|
5.6 milliseconds (msec)
Standard Deviation 129.790
|
-35.7 milliseconds (msec)
Standard Deviation 112.038
|
13.1 milliseconds (msec)
Standard Deviation 78.368
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 4 h, n=19, 19, 19, 8, 11
|
-21.9 milliseconds (msec)
Standard Deviation 86.948
|
-54.7 milliseconds (msec)
Standard Deviation 173.646
|
-24.6 milliseconds (msec)
Standard Deviation 85.316
|
-17.9 milliseconds (msec)
Standard Deviation 97.684
|
7.3 milliseconds (msec)
Standard Deviation 94.243
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 6 h, n=19, 19, 19, 8, 11
|
-61.0 milliseconds (msec)
Standard Deviation 125.922
|
-23.2 milliseconds (msec)
Standard Deviation 183.705
|
-64.1 milliseconds (msec)
Standard Deviation 127.976
|
-106.1 milliseconds (msec)
Standard Deviation 160.044
|
-45.5 milliseconds (msec)
Standard Deviation 71.133
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 24 h, n=19, 19, 18, 8, 11
|
-4.7 milliseconds (msec)
Standard Deviation 108.355
|
10.5 milliseconds (msec)
Standard Deviation 95.865
|
6.0 milliseconds (msec)
Standard Deviation 103.940
|
-1.6 milliseconds (msec)
Standard Deviation 76.068
|
-18.8 milliseconds (msec)
Standard Deviation 81.880
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 20 min, n=19, 19, 19, 8, 11
|
4.8 milliseconds (msec)
Standard Deviation 15.094
|
-7.8 milliseconds (msec)
Standard Deviation 13.891
|
-1.7 milliseconds (msec)
Standard Deviation 9.306
|
2.2 milliseconds (msec)
Standard Deviation 18.150
|
-2.7 milliseconds (msec)
Standard Deviation 24.051
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 45 min, n=19, 19, 19, 8, 10
|
5.6 milliseconds (msec)
Standard Deviation 15.245
|
-0.8 milliseconds (msec)
Standard Deviation 12.037
|
-0.1 milliseconds (msec)
Standard Deviation 11.856
|
2.1 milliseconds (msec)
Standard Deviation 8.750
|
0.3 milliseconds (msec)
Standard Deviation 17.997
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 1 h, n=19, 19, 19, 8, 11
|
5.1 milliseconds (msec)
Standard Deviation 14.820
|
1.3 milliseconds (msec)
Standard Deviation 13.453
|
0.5 milliseconds (msec)
Standard Deviation 13.096
|
2.6 milliseconds (msec)
Standard Deviation 14.876
|
-0.1 milliseconds (msec)
Standard Deviation 23.941
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 2 h, n=19, 19, 19, 8, 11
|
-4.4 milliseconds (msec)
Standard Deviation 19.879
|
-9.2 milliseconds (msec)
Standard Deviation 19.465
|
-5.6 milliseconds (msec)
Standard Deviation 18.786
|
-10.5 milliseconds (msec)
Standard Deviation 15.296
|
-0.7 milliseconds (msec)
Standard Deviation 15.403
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 3 h, n=19, 19, 19, 8, 11
|
-5.2 milliseconds (msec)
Standard Deviation 21.154
|
-12.4 milliseconds (msec)
Standard Deviation 28.408
|
0.8 milliseconds (msec)
Standard Deviation 18.469
|
-10.8 milliseconds (msec)
Standard Deviation 15.253
|
-1.6 milliseconds (msec)
Standard Deviation 15.403
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 4 h, n=19, 19, 19, 8, 11
|
-7.1 milliseconds (msec)
Standard Deviation 27.773
|
-16.6 milliseconds (msec)
Standard Deviation 29.661
|
-6.3 milliseconds (msec)
Standard Deviation 14.699
|
-5.0 milliseconds (msec)
Standard Deviation 16.399
|
-0.9 milliseconds (msec)
Standard Deviation 16.693
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 6 h, n=19, 19, 19, 8, 11
|
-17.4 milliseconds (msec)
Standard Deviation 22.329
|
-14.1 milliseconds (msec)
Standard Deviation 26.540
|
-16.9 milliseconds (msec)
Standard Deviation 20.348
|
-20.0 milliseconds (msec)
Standard Deviation 22.842
|
-8.6 milliseconds (msec)
Standard Deviation 11.990
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QT, 24 h, n=19, 19, 18, 8, 11
|
-9.3 milliseconds (msec)
Standard Deviation 39.366
|
-4.8 milliseconds (msec)
Standard Deviation 19.461
|
1.1 milliseconds (msec)
Standard Deviation 30.186
|
-0.3 milliseconds (msec)
Standard Deviation 14.331
|
-1.1 milliseconds (msec)
Standard Deviation 17.099
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 20 min, n=19, 19, 19, 8, 11
|
-5.6 milliseconds (msec)
Standard Deviation 10.206
|
-5.7 milliseconds (msec)
Standard Deviation 18.465
|
-2.5 milliseconds (msec)
Standard Deviation 13.058
|
7.6 milliseconds (msec)
Standard Deviation 24.453
|
-4.8 milliseconds (msec)
Standard Deviation 27.410
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 45 min, n=19, 19, 19, 8, 10
|
4.5 milliseconds (msec)
Standard Deviation 21.312
|
-2.8 milliseconds (msec)
Standard Deviation 13.737
|
0.9 milliseconds (msec)
Standard Deviation 13.972
|
18.5 milliseconds (msec)
Standard Deviation 20.184
|
-1.8 milliseconds (msec)
Standard Deviation 24.471
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 1 h, n=19, 19, 19, 8, 11
|
-0.9 milliseconds (msec)
Standard Deviation 19.298
|
-7.5 milliseconds (msec)
Standard Deviation 15.779
|
1.2 milliseconds (msec)
Standard Deviation 12.743
|
7.9 milliseconds (msec)
Standard Deviation 11.202
|
-3.8 milliseconds (msec)
Standard Deviation 30.201
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 2 h, n=19, 19, 19, 8, 11
|
-4.3 milliseconds (msec)
Standard Deviation 16.691
|
-3.9 milliseconds (msec)
Standard Deviation 18.963
|
0.0 milliseconds (msec)
Standard Deviation 16.015
|
-4.4 milliseconds (msec)
Standard Deviation 22.214
|
2.1 milliseconds (msec)
Standard Deviation 17.456
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 3 h, n=19, 19, 19, 8, 11
|
-1.8 milliseconds (msec)
Standard Deviation 20.177
|
0.0 milliseconds (msec)
Standard Deviation 19.550
|
0.4 milliseconds (msec)
Standard Deviation 20.161
|
-3.8 milliseconds (msec)
Standard Deviation 17.665
|
-3.9 milliseconds (msec)
Standard Deviation 13.908
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 4 h, n=19, 19, 19, 8, 11
|
-0.6 milliseconds (msec)
Standard Deviation 30.768
|
-4.4 milliseconds (msec)
Standard Deviation 13.490
|
-1.3 milliseconds (msec)
Standard Deviation 11.909
|
-1.5 milliseconds (msec)
Standard Deviation 14.136
|
-1.6 milliseconds (msec)
Standard Deviation 11.578
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 6 h, n=19, 19, 19, 8, 11
|
-3.9 milliseconds (msec)
Standard Deviation 16.976
|
-9.3 milliseconds (msec)
Standard Deviation 18.612
|
-2.9 milliseconds (msec)
Standard Deviation 15.326
|
3.4 milliseconds (msec)
Standard Deviation 12.821
|
2.0 milliseconds (msec)
Standard Deviation 10.667
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(B), 24 h, n=19, 19, 18, 8, 11
|
-9.0 milliseconds (msec)
Standard Deviation 32.387
|
-7.1 milliseconds (msec)
Standard Deviation 15.386
|
-0.2 milliseconds (msec)
Standard Deviation 14.676
|
0.3 milliseconds (msec)
Standard Deviation 9.022
|
3.8 milliseconds (msec)
Standard Deviation 18.294
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 20 min, n=19, 19, 18, 8, 11
|
-2.0 milliseconds (msec)
Standard Deviation 10.761
|
-6.5 milliseconds (msec)
Standard Deviation 14.867
|
-2.2 milliseconds (msec)
Standard Deviation 9.227
|
5.9 milliseconds (msec)
Standard Deviation 19.428
|
-4.0 milliseconds (msec)
Standard Deviation 26.022
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 45 min, n=19, 19, 19, 8, 10
|
4.9 milliseconds (msec)
Standard Deviation 16.508
|
-2.1 milliseconds (msec)
Standard Deviation 11.430
|
0.6 milliseconds (msec)
Standard Deviation 9.920
|
13.0 milliseconds (msec)
Standard Deviation 12.102
|
-0.9 milliseconds (msec)
Standard Deviation 20.795
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 1 h, n=19, 19, 19, 8, 11
|
1.1 milliseconds (msec)
Standard Deviation 15.088
|
-4.4 milliseconds (msec)
Standard Deviation 13.387
|
1.0 milliseconds (msec)
Standard Deviation 9.193
|
6.2 milliseconds (msec)
Standard Deviation 8.626
|
-2.4 milliseconds (msec)
Standard Deviation 26.900
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 2 h, n=19, 19, 19, 8, 11
|
-4.4 milliseconds (msec)
Standard Deviation 14.122
|
-5.8 milliseconds (msec)
Standard Deviation 10.606
|
-2.0 milliseconds (msec)
Standard Deviation 11.272
|
-6.5 milliseconds (msec)
Standard Deviation 16.576
|
1.2 milliseconds (msec)
Standard Deviation 13.750
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 3 h, n=19, 19, 19, 8, 11
|
-3.1 milliseconds (msec)
Standard Deviation 17.341
|
-4.4 milliseconds (msec)
Standard Deviation 13.383
|
0.5 milliseconds (msec)
Standard Deviation 14.498
|
-6.2 milliseconds (msec)
Standard Deviation 11.842
|
-3.2 milliseconds (msec)
Standard Deviation 10.836
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 4 h, n=19, 19, 19, 8, 11
|
-3.1 milliseconds (msec)
Standard Deviation 28.679
|
-8.8 milliseconds (msec)
Standard Deviation 10.344
|
-3.0 milliseconds (msec)
Standard Deviation 9.373
|
-2.7 milliseconds (msec)
Standard Deviation 11.136
|
10.836 milliseconds (msec)
Standard Deviation 8.648
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 6 h, n=19, 19, 19, 8, 11
|
-8.7 milliseconds (msec)
Standard Deviation 13.113
|
-11.1 milliseconds (msec)
Standard Deviation 10.871
|
-7.8 milliseconds (msec)
Standard Deviation 10.278
|
-4.7 milliseconds (msec)
Standard Deviation 5.959
|
-1.7 milliseconds (msec)
Standard Deviation 6.561
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
QTc(F), 24 h, n=19, 19, 18, 8, 11
|
-9.2 milliseconds (msec)
Standard Deviation 33.102
|
-6.4 milliseconds (msec)
Standard Deviation 13.364
|
0.0 milliseconds (msec)
Standard Deviation 17.882
|
0.0 milliseconds (msec)
Standard Deviation 0.0
|
2.0 milliseconds (msec)
Standard Deviation 15.496
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 20 min, n=19, 19, 19, 8, 11
|
48.9 milliseconds (msec)
Standard Deviation 57.110
|
-9.0 milliseconds (msec)
Standard Deviation 75.077
|
3.9 milliseconds (msec)
Standard Deviation 73.786
|
-29.2 milliseconds (msec)
Standard Deviation 123.015
|
4.7 milliseconds (msec)
Standard Deviation 31.266
|
|
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
RR, 45 min, n=19, 19, 19, 8, 10
|
5.6 milliseconds (msec)
Standard Deviation 96.803
|
9.1 milliseconds (msec)
Standard Deviation 65.366
|
-5.7 milliseconds (msec)
Standard Deviation 81.079
|
-73.0 milliseconds (msec)
Standard Deviation 130.999
|
4.0 milliseconds (msec)
Standard Deviation 69.539
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: PP Population. Only those participants available at the indicated time points were assessed.
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 .
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=6 Participants
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).
|
GW642444H 100 µg
n=12 Participants
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).
|
|---|---|---|---|---|---|
|
Mean FEV1 Over 23 and 24 Hours After Dosing
|
1.432 Liters
Standard Error 0.0402
|
1.622 Liters
Standard Error 0.0431
|
1.638 Liters
Standard Error 0.0415
|
1.642 Liters
Standard Error 0.0650
|
1.569 Liters
Standard Error 0.0501
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: PP Population. Only those participants available at the indicated time points were assessed.
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).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
WM QTcB
|
419.68 Milliseconds (msec)
Standard Error 2.150
|
419.56 Milliseconds (msec)
Standard Error 2.378
|
424.18 Milliseconds (msec)
Standard Error 2.230
|
422.36 Milliseconds (msec)
Standard Error 3.517
|
419.70 Milliseconds (msec)
Standard Error 2.714
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
WM QTcF,
|
409.13 Milliseconds (msec)
Standard Error 1.696
|
408.31 Milliseconds (msec)
Standard Error 1.898
|
412.99 Milliseconds (msec)
Standard Error 1.760
|
409.50 Milliseconds (msec)
Standard Error 2.842
|
409.82 Milliseconds (msec)
Standard Error 2.163
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
Max QTcF
|
425.34 Milliseconds (msec)
Standard Error 2.900
|
421.73 Milliseconds (msec)
Standard Error 3.286
|
422.55 Milliseconds (msec)
Standard Error 3.025
|
422.41 Milliseconds (msec)
Standard Error 5.000
|
422.99 Milliseconds (msec)
Standard Error 3.766
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
Max QTcB
|
439.37 Milliseconds (msec)
Standard Error 3.714
|
437.06 Milliseconds (msec)
Standard Error 4.104
|
434.62 Milliseconds (msec)
Standard Error 3.850
|
438.14 Milliseconds (msec)
Standard Error 6.059
|
436.75 Milliseconds (msec)
Standard Error 4.681
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: PP Population. Only those participants available at the indicated time points were assessed.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate
WM Heart rate
|
71.12 Beats per minute
Standard Error 1.320
|
71.76 Beats per minute
Standard Error 1.473
|
71.57 Beats per minute
Standard Error 1.377
|
73.50 Beats per minute
Standard Error 2.179
|
71.22 Beats per minute
Standard Error 1.734
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate
Max Heart rate
|
77.88 Beats per minute
Standard Error 1.784
|
79.95 Beats per minute
Standard Error 1.948
|
76.13 Beats per minute
Standard Error 1.845
|
77.77 Beats per minute
Standard Error 2.764
|
77.16 Beats per minute
Standard Error 2.248
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: PP Population. Only those participants available at the indicated time points were assessed.
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.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=19 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=11 Participants
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).
|
|---|---|---|---|---|---|
|
Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
WM SBP
|
126.92 Millimeters of mercury
Standard Error 1.223
|
126.28 Millimeters of mercury
Standard Error 1.388
|
127.82 Millimeters of mercury
Standard Error 1.284
|
128.99 Millimeters of mercury
Standard Error 2.146
|
125.10 Millimeters of mercury
Standard Error 1.621
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
Max SBP
|
133.23 Millimeters of mercury
Standard Error 1.521
|
133.06 Millimeters of mercury
Standard Error 1.714
|
133.91 Millimeters of mercury
Standard Error 1.591
|
135.24 Millimeters of mercury
Standard Error 2.625
|
131.13 Millimeters of mercury
Standard Error 1.994
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
WM DBP
|
80.36 Millimeters of mercury
Standard Error 1.017
|
79.74 Millimeters of mercury
Standard Error 1.133
|
80.04 Millimeters of mercury
Standard Error 1.056
|
83.46 Millimeters of mercury
Standard Error 1.721
|
77.46 Millimeters of mercury
Standard Error 1.321
|
|
Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
Max DBP
|
76.13 Millimeters of mercury
Standard Error 1.147
|
75.08 Millimeters of mercury
Standard Error 1.272
|
76.30 Millimeters of mercury
Standard Error 1.189
|
79.92 Millimeters of mercury
Standard Error 1.917
|
71.63 Millimeters of mercury
Standard Error 1.478
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: PP Population. Only those participants available at the indicated time points were assessed.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=6 Participants
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).
|
GW642444H 100 µg
n=12 Participants
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).
|
|---|---|---|---|---|---|
|
Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
Max Glucose, n=17, 20, 19, 6,10
|
6.73 Millimoles per liter (mmol/L)
Standard Error 0.342
|
6.61 Millimoles per liter (mmol/L)
Standard Error 0.370
|
6.65 Millimoles per liter (mmol/L)
Standard Error 0.342
|
6.99 Millimoles per liter (mmol/L)
Standard Error 0.608
|
6.09 Millimoles per liter (mmol/L)
Standard Error 0.436
|
|
Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
WM Glucose, n=16,18,19,6,10
|
5.94 Millimoles per liter (mmol/L)
Standard Error 0.204
|
5.86 Millimoles per liter (mmol/L)
Standard Error 0.227
|
5.95 Millimoles per liter (mmol/L)
Standard Error 0.200
|
6.25 Millimoles per liter (mmol/L)
Standard Error 0.345
|
5.71 Millimoles per liter (mmol/L)
Standard Error 0.251
|
|
Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
WM Potassium, n=15, 16, 17, 5,12
|
4.29 Millimoles per liter (mmol/L)
Standard Error 0.058
|
4.29 Millimoles per liter (mmol/L)
Standard Error 0.067
|
4.14 Millimoles per liter (mmol/L)
Standard Error 0.057
|
4.22 Millimoles per liter (mmol/L)
Standard Error 0.102
|
4.27 Millimoles per liter (mmol/L)
Standard Error 0.073
|
|
Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
Min Potassium, n=16, 20, 18, 6,12
|
4.02 Millimoles per liter (mmol/L)
Standard Error 0.052
|
4.03 Millimoles per liter (mmol/L)
Standard Error 0.053
|
3.97 Millimoles per liter (mmol/L)
Standard Error 0.052
|
4.08 Millimoles per liter (mmol/L)
Standard Error 0.082
|
4.08 Millimoles per liter (mmol/L)
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each treatment period (up to Study Day 54)Population: Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
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.
Outcome measures
| Measure |
Placebo
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=17 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=10 Participants
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).
|
|---|---|---|---|---|---|
|
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
GSK932009, AUC(0-t), n=0, 0, 0, 0, 0
|
—
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
|
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
GW642444, AUC(0-t), n=0, 17, 19, 8, 10
|
—
|
56.49 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 86.2
|
222.36 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 96.5
|
572.99 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 45.3
|
98.13 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 0.782
|
|
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
GW64244, AUC(0-1), n=0, 11, 18, 8, 10
|
—
|
58.01 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 25.4
|
106.31 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 44.5
|
196.24 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 23.9
|
54.85 picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation 28.3
|
|
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
GI179710, AUC (0-t), n=0, 0, 0, 1, 0
|
—
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
|
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
GW630200, AUC(0-t), n=0, 0, 0, 0, 0
|
—
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms.Hour/milliliter (pg.hr/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment period (up to Study Day 54)Population: PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
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.
Outcome measures
| Measure |
Placebo
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=12 Participants
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).
|
|---|---|---|---|---|---|
|
Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GW642444,n=0, 20, 19, 8, 12
|
—
|
78.16 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 43.9
|
150.60 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 53.1
|
259.96 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 22.2
|
73.70 picograms/milliliter (pg/mL)
Geometric Coefficient of Variation 35.7
|
|
Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GI179710,n=0, 0, 4, 7, 0
|
—
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
|
Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GW630200, n=0, 0, 0, 0, 0
|
—
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
|
Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GSK932009, n=0, 0, 0, 0, 0
|
—
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
NA picograms/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Insufficient data to define due to assay censoring.
|
SECONDARY outcome
Timeframe: Day 1 of each treatment period (up to Study Day 54)Population: PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
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.
Outcome measures
| Measure |
Placebo
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 Participants
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).
|
GW642444M 50 µg
n=19 Participants
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).
|
GW642444M 100 µg
n=8 Participants
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).
|
GW642444H 100 µg
n=12 Participants
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).
|
|---|---|---|---|---|---|
|
Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GW642444,n=0, 20, 19, 8, 12
|
—
|
0.175 Hours
Interval 0.03 to 2.0
|
0.200 Hours
Interval 0.08 to 1.0
|
0.425 Hours
Interval 0.15 to 1.03
|
0.500 Hours
Interval 0.2 to 2.07
|
|
Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GI179710,n=0, 0, 4, 7, 0
|
—
|
NA Hours
Insufficient data to define due to assay censoring.
|
0.140 Hours
Interval 0.0 to 0.18
|
0.170 Hours
Interval 0.07 to 0.33
|
NA Hours
Insufficient data to define due to assay censoring.
|
|
Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GW630200, n=0, 0, 0, 0, 0
|
—
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
|
Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
GSK932009, n=0, 0, 0, 0, 0
|
—
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
NA Hours
Insufficient data to define due to assay censoring.
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GW642444M 25 µg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GW642444M 50 µg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GW642444M 100 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GW642444H 100 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
|
GW642444M 25 µg
n=20 participants at risk
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).
|
GW642444M 50 µg
n=19 participants at risk
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).
|
GW642444M 100 µg
n=8 participants at risk
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).
|
GW642444H 100 µg
n=12 participants at risk
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).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.3%
1/19 • 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).
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.
|
5.0%
1/20 • 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).
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.
|
5.3%
1/19 • 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).
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.
|
0.00%
0/8 • 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).
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.
|
0.00%
0/12 • 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).
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.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • 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).
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.
|
0.00%
0/20 • 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).
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.
|
5.3%
1/19 • 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).
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.
|
0.00%
0/8 • 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).
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.
|
0.00%
0/12 • 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).
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.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • 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).
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.
|
0.00%
0/20 • 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).
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.
|
5.3%
1/19 • 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).
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.
|
0.00%
0/8 • 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).
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.
|
0.00%
0/12 • 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).
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER