Trial Outcomes & Findings for An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs. (NCT NCT00674817)
NCT ID: NCT00674817
Last Updated: 2021-10-20
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1
Results posted on
2021-10-20
Participant Flow
This study was conducted from 25Apr2008 to 19Oct2008 across two centers in Thailand and one center each in the United Kingdom and New Zealand. A total of 45 participants were planned to be enrolled.
A total of 44 participants were screened over period of 28 days and were enrolled in the study.
Participant milestones
| Measure |
Total Population
Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
|
|---|---|
|
Period 1
STARTED
|
44
|
|
Period 1
COMPLETED
|
41
|
|
Period 1
NOT COMPLETED
|
3
|
|
Period 2
STARTED
|
41
|
|
Period 2
COMPLETED
|
41
|
|
Period 2
NOT COMPLETED
|
0
|
|
Period 3
STARTED
|
41
|
|
Period 3
COMPLETED
|
39
|
|
Period 3
NOT COMPLETED
|
2
|
|
Period 4
STARTED
|
39
|
|
Period 4
COMPLETED
|
38
|
|
Period 4
NOT COMPLETED
|
1
|
|
Period 5
STARTED
|
38
|
|
Period 5
COMPLETED
|
38
|
|
Period 5
NOT COMPLETED
|
0
|
|
Period 6
STARTED
|
38
|
|
Period 6
COMPLETED
|
38
|
|
Period 6
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Total Population
Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
|
|---|---|
|
Period 1
Withdrawal by Subject
|
2
|
|
Period 1
Protocol Violation
|
1
|
|
Period 3
Adverse Event
|
1
|
|
Period 3
Protocol Violation
|
1
|
|
Period 4
Adverse Event
|
1
|
Baseline Characteristics
An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.
Baseline characteristics by cohort
| Measure |
Total Population
n=44 Participants
Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
|
|---|---|
|
Age, Continuous
Years
|
63.1 Years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1Population: Modified per protocol population included the participants who received at least one dose of the study drug where major deviations from the protocol had not occurred. Only those participants available at the specified time points were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.
1 hour
|
0.111 Liters
Standard Error 0.0146
|
0.113 Liters
Standard Error 0.0142
|
0.087 Liters
Standard Error 0.0144
|
0.111 Liters
Standard Error 0.0144
|
0.072 Liters
Standard Error 0.0144
|
0.094 Liters
Standard Error 0.0149
|
|
Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.
12 hour
|
0.141 Liters
Standard Error 0.0173
|
0.134 Liters
Standard Error 0.0170
|
0.127 Liters
Standard Error 0.0170
|
0.098 Liters
Standard Error 0.0171
|
0.002 Liters
Standard Error 0.0170
|
0.043 Liters
Standard Error 0.0174
|
|
Maximal Change in Forced Expiratory Volume in One Second (FEV1) From Baseline (Pre-dose on Day 1) in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h,12h and 24h.
24 hour
|
0.161 Liters
Standard Error 0.0166
|
0.175 Liters
Standard Error 0.0163
|
0.179 Liters
Standard Error 0.0162
|
0.172 Liters
Standard Error 0.0166
|
0.039 Liters
Standard Error 0.0163
|
0.049 Liters
Standard Error 0.0169
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1Population: Modified per protocol population. Only those participants available at the specified time points were analyzed.
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after a maximum inspiration as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.
24 hour
|
0.247 Liters
Standard Error 0.0398
|
0.205 Liters
Standard Error 0.0392
|
0.279 Liters
Standard Error 0.0388
|
0.214 Liters
Standard Error 0.0397
|
0.179 Liters
Standard Error 0.0393
|
0.113 Liters
Standard Error 0.0407
|
|
Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.
1 hour
|
0.169 Liters
Standard Error 0.0460
|
0.281 Liters
Standard Error 0.0449
|
0.167 Liters
Standard Error 0.0454
|
0.207 Liters
Standard Error 0.0454
|
0.234 Liters
Standard Error 0.0454
|
0.229 Liters
Standard Error 0.0472
|
|
Maximal Change in Forced Vital Capacity (FVC) in One Second From Pre-dose in Combination With Short Acting Bronchodialator (Salbutamol or Ipratropium Bromide) at 1h, 12h and 24h.
12 hour
|
0.160 Liters
Standard Error 0.0380
|
0.182 Liters
Standard Error 0.0375
|
0.188 Liters
Standard Error 0.0375
|
0.223 Liters
Standard Error 0.0375
|
0.068 Liters
Standard Error 0.0375
|
0.088 Liters
Standard Error 0.0385
|
SECONDARY outcome
Timeframe: Upto 82 daysPopulation: All subjects population
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE (SAE) is 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.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Participants with any AE
|
13 Participants
|
13 Participants
|
15 Participants
|
9 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Participants with any SAE
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 daysPopulation: All subjects population
The normal ranges of laboratory parameters were hemoglobin: 130-167 grams per deciliter (g/dL), platelets: 173-383 Giga per liter (GI/L), lymphocytes: 20.1-44.5 %, glucose: 3.8857-6.106 millimoles per liter (mmol/L), creatinine: 44.2-132.6 micromoles per liter (uM/L) , aspartate transaminases (AST): 12-32 international units per liter (IU/L), total bilirubin (TB): 4.275-25.65 uM/L and potassium: 3.4-4.7 mmol/L, respectively. Laboratory values recorded outside the normal range were considered of potential clinical concern (PCC).
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)
Hemoglobin high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)
Platelets high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)
Platelets low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)
Lymphocytes low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 27 hours post Day 1 dosingPopulation: All subjects population. Only those participants available at the specified time points were analyzed.
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was analyzed. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 4h
|
-2.36 Millimeters of mercury (mm of Hg)
Standard Deviation 8.963
|
4.20 Millimeters of mercury (mm of Hg)
Standard Deviation 12.107
|
3.27 Millimeters of mercury (mm of Hg)
Standard Deviation 9.680
|
2.68 Millimeters of mercury (mm of Hg)
Standard Deviation 9.689
|
0.63 Millimeters of mercury (mm of Hg)
Standard Deviation 10.947
|
2.38 Millimeters of mercury (mm of Hg)
Standard Deviation 10.101
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 13h
|
-4.19 Millimeters of mercury (mm of Hg)
Standard Deviation 11.638
|
-1.97 Millimeters of mercury (mm of Hg)
Standard Deviation 7.856
|
-0.56 Millimeters of mercury (mm of Hg)
Standard Deviation 8.152
|
-0.39 Millimeters of mercury (mm of Hg)
Standard Deviation 7.602
|
0.85 Millimeters of mercury (mm of Hg)
Standard Deviation 9.670
|
-0.34 Millimeters of mercury (mm of Hg)
Standard Deviation 8.380
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 24h
|
-0.95 Millimeters of mercury (mm of Hg)
Standard Deviation 6.411
|
3.13 Millimeters of mercury (mm of Hg)
Standard Deviation 8.624
|
0.37 Millimeters of mercury (mm of Hg)
Standard Deviation 5.634
|
2.32 Millimeters of mercury (mm of Hg)
Standard Deviation 7.932
|
-0.23 Millimeters of mercury (mm of Hg)
Standard Deviation 6.799
|
-0.58 Millimeters of mercury (mm of Hg)
Standard Deviation 7.310
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 25h
|
-2.26 Millimeters of mercury (mm of Hg)
Standard Deviation 6.976
|
0.75 Millimeters of mercury (mm of Hg)
Standard Deviation 7.171
|
1.24 Millimeters of mercury (mm of Hg)
Standard Deviation 8.166
|
1.49 Millimeters of mercury (mm of Hg)
Standard Deviation 8.474
|
0.78 Millimeters of mercury (mm of Hg)
Standard Deviation 5.753
|
2.22 Millimeters of mercury (mm of Hg)
Standard Deviation 7.536
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 27h
|
-3.28 Millimeters of mercury (mm of Hg)
Standard Deviation 7.229
|
-0.03 Millimeters of mercury (mm of Hg)
Standard Deviation 8.192
|
-2.51 Millimeters of mercury (mm of Hg)
Standard Deviation 7.871
|
-1.12 Millimeters of mercury (mm of Hg)
Standard Deviation 7.541
|
-3.35 Millimeters of mercury (mm of Hg)
Standard Deviation 9.270
|
-1.55 Millimeters of mercury (mm of Hg)
Standard Deviation 7.202
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 1 hour(h)
|
-1.33 Millimeters of mercury (mm of Hg)
Standard Deviation 12.321
|
3.10 Millimeters of mercury (mm of Hg)
Standard Deviation 11.115
|
0.61 Millimeters of mercury (mm of Hg)
Standard Deviation 10.703
|
-1.73 Millimeters of mercury (mm of Hg)
Standard Deviation 10.301
|
-0.13 Millimeters of mercury (mm of Hg)
Standard Deviation 12.096
|
-0.33 Millimeters of mercury (mm of Hg)
Standard Deviation 11.235
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 2h
|
-3.41 Millimeters of mercury (mm of Hg)
Standard Deviation 10.918
|
1.22 Millimeters of mercury (mm of Hg)
Standard Deviation 10.741
|
3.49 Millimeters of mercury (mm of Hg)
Standard Deviation 7.919
|
2.33 Millimeters of mercury (mm of Hg)
Standard Deviation 11.450
|
1.03 Millimeters of mercury (mm of Hg)
Standard Deviation 8.195
|
1.31 Millimeters of mercury (mm of Hg)
Standard Deviation 12.131
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 9h
|
-0.87 Millimeters of mercury (mm of Hg)
Standard Deviation 12.064
|
3.08 Millimeters of mercury (mm of Hg)
Standard Deviation 10.598
|
1.07 Millimeters of mercury (mm of Hg)
Standard Deviation 10.900
|
2.71 Millimeters of mercury (mm of Hg)
Standard Deviation 12.125
|
0.00 Millimeters of mercury (mm of Hg)
Standard Deviation 9.748
|
2.95 Millimeters of mercury (mm of Hg)
Standard Deviation 12.237
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 12h
|
-3.49 Millimeters of mercury (mm of Hg)
Standard Deviation 11.850
|
2.08 Millimeters of mercury (mm of Hg)
Standard Deviation 15.895
|
-0.46 Millimeters of mercury (mm of Hg)
Standard Deviation 11.145
|
0.32 Millimeters of mercury (mm of Hg)
Standard Deviation 12.445
|
-1.95 Millimeters of mercury (mm of Hg)
Standard Deviation 11.618
|
-0.51 Millimeters of mercury (mm of Hg)
Standard Deviation 10.450
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 13h
|
-5.62 Millimeters of mercury (mm of Hg)
Standard Deviation 11.947
|
3.46 Millimeters of mercury (mm of Hg)
Standard Deviation 13.742
|
1.05 Millimeters of mercury (mm of Hg)
Standard Deviation 11.866
|
2.27 Millimeters of mercury (mm of Hg)
Standard Deviation 13.808
|
3.45 Millimeters of mercury (mm of Hg)
Standard Deviation 15.591
|
2.21 Millimeters of mercury (mm of Hg)
Standard Deviation 9.935
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 24h
|
-3.31 Millimeters of mercury (mm of Hg)
Standard Deviation 12.092
|
4.65 Millimeters of mercury (mm of Hg)
Standard Deviation 10.843
|
1.41 Millimeters of mercury (mm of Hg)
Standard Deviation 11.469
|
2.56 Millimeters of mercury (mm of Hg)
Standard Deviation 12.616
|
-1.50 Millimeters of mercury (mm of Hg)
Standard Deviation 10.627
|
1.68 Millimeters of mercury (mm of Hg)
Standard Deviation 10.547
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 25h
|
-3.38 Millimeters of mercury (mm of Hg)
Standard Deviation 11.679
|
4.05 Millimeters of mercury (mm of Hg)
Standard Deviation 14.022
|
2.32 Millimeters of mercury (mm of Hg)
Standard Deviation 13.083
|
2.44 Millimeters of mercury (mm of Hg)
Standard Deviation 9.453
|
-0.10 Millimeters of mercury (mm of Hg)
Standard Deviation 12.349
|
1.49 Millimeters of mercury (mm of Hg)
Standard Deviation 11.428
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
SBP, 27h
|
-5.59 Millimeters of mercury (mm of Hg)
Standard Deviation 9.999
|
2.43 Millimeters of mercury (mm of Hg)
Standard Deviation 11.670
|
-3.24 Millimeters of mercury (mm of Hg)
Standard Deviation 11.432
|
-0.32 Millimeters of mercury (mm of Hg)
Standard Deviation 12.875
|
-3.25 Millimeters of mercury (mm of Hg)
Standard Deviation 10.463
|
-1.24 Millimeters of mercury (mm of Hg)
Standard Deviation 10.899
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 1h
|
-1.59 Millimeters of mercury (mm of Hg)
Standard Deviation 6.754
|
-1.41 Millimeters of mercury (mm of Hg)
Standard Deviation 6.340
|
1.25 Millimeters of mercury (mm of Hg)
Standard Deviation 8.002
|
-2.66 Millimeters of mercury (mm of Hg)
Standard Deviation 6.814
|
0.55 Millimeters of mercury (mm of Hg)
Standard Deviation 6.737
|
-2.21 Millimeters of mercury (mm of Hg)
Standard Deviation 8.594
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 2h
|
-4.15 Millimeters of mercury (mm of Hg)
Standard Deviation 7.744
|
-2.27 Millimeters of mercury (mm of Hg)
Standard Deviation 7.871
|
0.07 Millimeters of mercury (mm of Hg)
Standard Deviation 7.438
|
0.48 Millimeters of mercury (mm of Hg)
Standard Deviation 6.939
|
-1.48 Millimeters of mercury (mm of Hg)
Standard Deviation 6.473
|
-1.05 Millimeters of mercury (mm of Hg)
Standard Deviation 7.189
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 4h
|
-0.26 Millimeters of mercury (mm of Hg)
Standard Deviation 6.332
|
1.23 Millimeters of mercury (mm of Hg)
Standard Deviation 6.078
|
1.24 Millimeters of mercury (mm of Hg)
Standard Deviation 6.689
|
0.12 Millimeters of mercury (mm of Hg)
Standard Deviation 8.134
|
1.38 Millimeters of mercury (mm of Hg)
Standard Deviation 8.350
|
1.54 Millimeters of mercury (mm of Hg)
Standard Deviation 6.353
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 9h
|
-1.59 Millimeters of mercury (mm of Hg)
Standard Deviation 7.923
|
0.03 Millimeters of mercury (mm of Hg)
Standard Deviation 7.882
|
-1.73 Millimeters of mercury (mm of Hg)
Standard Deviation 7.820
|
-0.34 Millimeters of mercury (mm of Hg)
Standard Deviation 9.175
|
0.28 Millimeters of mercury (mm of Hg)
Standard Deviation 6.373
|
-0.79 Millimeters of mercury (mm of Hg)
Standard Deviation 8.581
|
|
Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
DBP, 12h
|
-3.18 Millimeters of mercury (mm of Hg)
Standard Deviation 8.742
|
-1.25 Millimeters of mercury (mm of Hg)
Standard Deviation 7.655
|
-2.68 Millimeters of mercury (mm of Hg)
Standard Deviation 8.329
|
-0.90 Millimeters of mercury (mm of Hg)
Standard Deviation 7.605
|
-3.05 Millimeters of mercury (mm of Hg)
Standard Deviation 7.414
|
-0.51 Millimeters of mercury (mm of Hg)
Standard Deviation 7.026
|
SECONDARY outcome
Timeframe: Up to 27 hours post Day 1 dosingPopulation: All subjects population. Only those participants available at the specified time points were analyzed.
Heart rate was considered as a measure of vital sign. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
4h
|
-0.71 Beats per minute
Standard Deviation 11.094
|
1.13 Beats per minute
Standard Deviation 6.501
|
-3.59 Beats per minute
Standard Deviation 9.389
|
-1.78 Beats per minute
Standard Deviation 6.031
|
-4.75 Beats per minute
Standard Deviation 6.636
|
-3.97 Beats per minute
Standard Deviation 7.069
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
12h 15 minutes
|
3.95 Beats per minute
Standard Deviation 7.729
|
5.35 Beats per minute
Standard Deviation 7.608
|
1.83 Beats per minute
Standard Deviation 6.364
|
4.10 Beats per minute
Standard Deviation 7.612
|
1.80 Beats per minute
Standard Deviation 6.992
|
2.05 Beats per minute
Standard Deviation 8.220
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
12h 35 minutes
|
4.97 Beats per minute
Standard Deviation 7.741
|
6.90 Beats per minute
Standard Deviation 7.558
|
1.51 Beats per minute
Standard Deviation 6.856
|
3.41 Beats per minute
Standard Deviation 8.465
|
2.28 Beats per minute
Standard Deviation 6.520
|
1.29 Beats per minute
Standard Deviation 6.534
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
12h 55 minutes
|
5.79 Beats per minute
Standard Deviation 8.694
|
6.50 Beats per minute
Standard Deviation 8.124
|
1.07 Beats per minute
Standard Deviation 7.424
|
1.90 Beats per minute
Standard Deviation 7.671
|
0.98 Beats per minute
Standard Deviation 7.416
|
1.37 Beats per minute
Standard Deviation 8.065
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
24h 35 minutes
|
0.23 Beats per minute
Standard Deviation 8.806
|
0.53 Beats per minute
Standard Deviation 7.990
|
-2.93 Beats per minute
Standard Deviation 6.218
|
-1.02 Beats per minute
Standard Deviation 6.901
|
-4.48 Beats per minute
Standard Deviation 6.361
|
-4.63 Beats per minute
Standard Deviation 6.724
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
24h 55 minutes
|
1.05 Beats per minute
Standard Deviation 8.617
|
0.83 Beats per minute
Standard Deviation 8.650
|
-2.46 Beats per minute
Standard Deviation 9.223
|
-2.05 Beats per minute
Standard Deviation 6.488
|
-4.13 Beats per minute
Standard Deviation 7.198
|
-4.21 Beats per minute
Standard Deviation 7.037
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
27h
|
6.74 Beats per minute
Standard Deviation 9.402
|
6.38 Beats per minute
Standard Deviation 9.440
|
1.17 Beats per minute
Standard Deviation 9.132
|
4.44 Beats per minute
Standard Deviation 9.394
|
2.05 Beats per minute
Standard Deviation 7.968
|
2.68 Beats per minute
Standard Deviation 8.817
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
1h
|
-2.56 Beats per minute
Standard Deviation 10.246
|
-1.37 Beats per minute
Standard Deviation 8.546
|
-3.90 Beats per minute
Standard Deviation 7.761
|
-2.27 Beats per minute
Standard Deviation 7.099
|
-3.55 Beats per minute
Standard Deviation 9.047
|
-3.10 Beats per minute
Standard Deviation 6.585
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
1h 15 minutes
|
-0.95 Beats per minute
Standard Deviation 8.712
|
-0.46 Beats per minute
Standard Deviation 7.328
|
-2.80 Beats per minute
Standard Deviation 7.118
|
-0.15 Beats per minute
Standard Deviation 6.624
|
-4.03 Beats per minute
Standard Deviation 7.540
|
-1.74 Beats per minute
Standard Deviation 5.915
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
1h 35 minutes
|
-0.03 Beats per minute
Standard Deviation 8.481
|
1.51 Beats per minute
Standard Deviation 7.166
|
-2.34 Beats per minute
Standard Deviation 7.275
|
-0.98 Beats per minute
Standard Deviation 5.943
|
-3.63 Beats per minute
Standard Deviation 6.717
|
-2.36 Beats per minute
Standard Deviation 6.098
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
1h 55 minutes
|
3.21 Beats per minute
Standard Deviation 9.359
|
4.54 Beats per minute
Standard Deviation 7.246
|
-3.46 Beats per minute
Standard Deviation 7.232
|
-0.39 Beats per minute
Standard Deviation 6.629
|
-3.63 Beats per minute
Standard Deviation 6.636
|
-2.21 Beats per minute
Standard Deviation 6.420
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
9h
|
1.92 Beats per minute
Standard Deviation 6.247
|
2.97 Beats per minute
Standard Deviation 6.815
|
-1.66 Beats per minute
Standard Deviation 7.529
|
1.37 Beats per minute
Standard Deviation 7.569
|
-0.70 Beats per minute
Standard Deviation 8.879
|
0.28 Beats per minute
Standard Deviation 7.215
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
12h
|
1.95 Beats per minute
Standard Deviation 7.567
|
3.65 Beats per minute
Standard Deviation 8.469
|
1.46 Beats per minute
Standard Deviation 8.521
|
2.83 Beats per minute
Standard Deviation 7.752
|
2.68 Beats per minute
Standard Deviation 8.689
|
1.87 Beats per minute
Standard Deviation 6.993
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
24h
|
-2.36 Beats per minute
Standard Deviation 8.142
|
-1.08 Beats per minute
Standard Deviation 7.145
|
-3.24 Beats per minute
Standard Deviation 5.267
|
-1.85 Beats per minute
Standard Deviation 7.189
|
-3.63 Beats per minute
Standard Deviation 8.079
|
-4.55 Beats per minute
Standard Deviation 7.576
|
|
Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
24h 15 minutes
|
-1.49 Beats per minute
Standard Deviation 8.705
|
-1.60 Beats per minute
Standard Deviation 7.938
|
-0.83 Beats per minute
Standard Deviation 7.297
|
-0.98 Beats per minute
Standard Deviation 7.666
|
-2.95 Beats per minute
Standard Deviation 6.972
|
-4.03 Beats per minute
Standard Deviation 8.284
|
SECONDARY outcome
Timeframe: From dosing until 24h post-dose.Population: All subjects population
Analysis QTc interval of ECG was performed by Bazett's formula (QTc B) and Fridericia's correction (QTc F). Number of participants with abnormal ECG findings were recorded. Any participant with QTc(B) or QTc(F) \>500 milliseconds (msec) or uncorrected QT \>600 msec (machine or manual over read) was withdrawn from the study. Participants that had right bundle branch block with QTc(B) or QTc(F) \>530 msec were also withdrawn from the study.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcB, <=30 msec
|
26 Participants
|
31 Participants
|
35 Participants
|
33 Participants
|
36 Participants
|
31 Participants
|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcB, >30 to <= 59 msec
|
12 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcF, >=60 msec
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcB, >=60 msec
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcF, <=30 msec
|
34 Participants
|
31 Participants
|
37 Participants
|
36 Participants
|
36 Participants
|
35 Participants
|
|
Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
QTcF, >30 to <= 59 msec
|
5 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h)Population: Modified per protocol population
Analysis of QT (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as least square (LS) mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 4 Hours After Dosing
|
14.34 msec
Standard Deviation 1.865
|
14.98 msec
Standard Deviation 1.827
|
12.31 msec
Standard Deviation 1.824
|
11.99 msec
Standard Deviation 1.839
|
10.60 msec
Standard Deviation 1.844
|
13.22 msec
Standard Deviation 1.890
|
SECONDARY outcome
Timeframe: From dosing until 27 hours (0-27h)Population: Modified per protocol population
Analysis of Q T (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data .
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 27 Hours After Dosing
|
19.70 msec
Standard Deviation 2.152
|
19.53 msec
Standard Deviation 2.104
|
17.41 msec
Standard Deviation 2.100
|
17.45 msec
Standard Deviation 2.119
|
15.14 msec
Standard Deviation 2.125
|
18.60 msec
Standard Deviation 2.184
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h)Population: Modified per protocol population. Only those participants available at the specified time points were analyzed.
Analysis of QT(F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=37 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(F) in Supine Position From 0 to 4 Hours
|
5.42 msec
Standard Deviation 1.565
|
7.53 msec
Standard Deviation 1.536
|
4.59 msec
Standard Deviation 1.535
|
6.23 msec
Standard Deviation 1.546
|
4.17 msec
Standard Deviation 1.549
|
8.18 msec
Standard Deviation 1.597
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h) and 27 hours (0-27h)Population: Modified Per Protocol population.
Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data .
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours and 0 to 27 Hours
0-4 hours
|
16.70 msec
Standard Error 2.078
|
19.51 msec
Standard Error 2.035
|
9.19 msec
Standard Error 2.033
|
10.77 msec
Standard Error 2.047
|
6.50 msec
Standard Error 2.054
|
11.65 msec
Standard Error 2.109
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours and 0 to 27 Hours
0-27 hours
|
24.17 msec
Standard Error 2.390
|
25.88 msec
Standard Error 2.339
|
17.33 msec
Standard Error 2.337
|
17.83 msec
Standard Error 2.353
|
12.94 msec
Standard Error 2.362
|
19.91 msec
Standard Error 2.429
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h)Population: Modified Per Protocol population.
Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=37 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours
|
5.27 msec
Standard Error 1.569
|
9.08 msec
Standard Error 1.542
|
0.08 msec
Standard Error 1.542
|
4.44 msec
Standard Error 1.550
|
0.07 msec
Standard Error 1.555
|
6.12 msec
Standard Error 1.602
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)Population: Modified Per Protocol population.
Heart rate was measured in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.
0-4 h
|
7.51 Beats per minute
Standard Error 1.125
|
7.90 Beats per minute
Standard Error 1.099
|
2.18 Beats per minute
Standard Error 1.097
|
3.17 Beats per minute
Standard Error 1.109
|
0.92 Beats per minute
Standard Error 1.110
|
0.92 Beats per minute
Standard Error 1.139
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.
0-27 h
|
13.33 Beats per minute
Standard Error 1.011
|
12.92 Beats per minute
Standard Error 0.988
|
9.49 Beats per minute
Standard Error 0.987
|
10.28 Beats per minute
Standard Error 0.998
|
9.21 Beats per minute
Standard Error 0.998
|
8.66 Beats per minute
Standard Error 1.024
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h)Population: Modified Per Protocol population. Data is presented for the participants available at the time of assessment.
Heart rate was recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=37 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Weighted Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate in Supine Position From 0 to 4 Hours
|
0.52 Beats per minute
Standard Error 0.729
|
1.77 Beats per minute
Standard Error 0.713
|
-2.93 Beats per minute
Standard Error 0.714
|
-1.27 Beats per minute
Standard Error 0.720
|
-3.57 Beats per minute
Standard Error 0.721
|
-2.21 Beats per minute
Standard Error 0.745
|
SECONDARY outcome
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean changePopulation: Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Systolic blood pressure (SBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/ (MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours
MC from BL,SBP,0-27h
|
10.89 Millimeters of mercury
Standard Error 1.530
|
15.93 Millimeters of mercury
Standard Error 1.488
|
14.08 Millimeters of mercury
Standard Error 1.477
|
12.87 Millimeters of mercury
Standard Error 1.495
|
14.16 Millimeters of mercury
Standard Error 1.493
|
14.10 Millimeters of mercury
Standard Error 1.527
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours
MC from BL,SBP,0-4h
|
5.61 Millimeters of mercury
Standard Error 1.452
|
8.06 Millimeters of mercury
Standard Error 1.409
|
8.05 Millimeters of mercury
Standard Error 1.394
|
5.55 Millimeters of mercury
Standard Error 1.414
|
7.45 Millimeters of mercury
Standard Error 1.412
|
7.74 Millimeters of mercury
Standard Error 1.448
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Supine Systolic Blood Pressure (SBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine SBP Over 4 Hours
WMC from BL SBP,0-4h
|
-0.34 Millimeters of mercury
Standard Error 1.103
|
0.92 Millimeters of mercury
Standard Error 1.071
|
2.24 Millimeters of mercury
Standard Error 1.063
|
0.10 Millimeters of mercury
Standard Error 1.076
|
1.06 Millimeters of mercury
Standard Error 1.075
|
0.82 Millimeters of mercury
Standard Error 1.113
|
SECONDARY outcome
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean changePopulation: Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Diastolic blood pressure (DBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/(MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data .
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours
MC from BL, DBP, 0-4h
|
-5.53 Millimeters of mercury
Standard Error 0.971
|
-5.76 Millimeters of mercury
Standard Error 0.946
|
-3.26 Millimeters of mercury
Standard Error 0.942
|
-5.49 Millimeters of mercury
Standard Error 0.954
|
-4.96 Millimeters of mercury
Standard Error 0.954
|
-4.42 Millimeters of mercury
Standard Error 0.979
|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours
MC from BL, DBP, 0-27h
|
-10.04 Millimeters of mercury
Standard Error 0.953
|
-9.20 Millimeters of mercury
Standard Error 0.930
|
-9.12 Millimeters of mercury
Standard Error 0.928
|
-8.72 Millimeters of mercury
Standard Error 0.938
|
-9.66 Millimeters of mercury
Standard Error 0.938
|
-9.18 Millimeters of mercury
Standard Error 0.959
|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Supine Diastolic Blood Pressure (DBP) Over 4 and 27 Hours and Weighted Mean Change From Baseline in Supine DBP Over 4 Hours
WMC from BL, DBP, 0-4h
|
-1.30 Millimeters of mercury
Standard Error 0.733
|
-1.25 Millimeters of mercury
Standard Error 0.715
|
0.75 Millimeters of mercury
Standard Error 0.713
|
-0.80 Millimeters of mercury
Standard Error 0.721
|
-0.12 Millimeters of mercury
Standard Error 0.721
|
-0.44 Millimeters of mercury
Standard Error 0.747
|
SECONDARY outcome
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean changePopulation: Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in glucose (GLU) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours
MC from BL, Glu, 0-4h
|
0.66 Millimoles per Liter
Standard Error 0.186
|
0.53 Millimoles per Liter
Standard Error 0.182
|
0.52 Millimoles per Liter
Standard Error 0.182
|
0.53 Millimoles per Liter
Standard Error 0.186
|
0.13 Millimoles per Liter
Standard Error 0.184
|
0.22 Millimoles per Liter
Standard Error 0.189
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours
MC from BL, Glu, 0-27h
|
2.71 Millimoles per Liter
Standard Error 0.236
|
2.13 Millimoles per Liter
Standard Error 0.230
|
1.78 Millimoles per Liter
Standard Error 0.230
|
1.87 Millimoles per Liter
Standard Error 0.235
|
1.83 Millimoles per Liter
Standard Error 0.232
|
1.30 Millimoles per Liter
Standard Error 0.239
|
|
Maximum Change From Baseline (Pre-dose on Day 1) in Glucose Over 4 and 27 Hours and Weighted Mean Change From Baseline in Glucose Over 4 Hours
WMC from BL, Glu, 0-4h
|
0.02 Millimoles per Liter
Standard Error 0.083
|
0.02 Millimoles per Liter
Standard Error 0.081
|
-0.12 Millimoles per Liter
Standard Error 0.081
|
-0.08 Millimoles per Liter
Standard Error 0.082
|
-0.29 Millimoles per Liter
Standard Error 0.082
|
0.19 Millimoles per Liter
Standard Error 0.085
|
SECONDARY outcome
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean changePopulation: Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in potassium (K) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=40 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours
MC from BL, K, 0-27h
|
-0.53 Millimoles per Liter
Standard Error 0.042
|
-0.62 Millimoles per Liter
Standard Error 0.040
|
-0.42 Millimoles per Liter
Standard Error 0.041
|
-0.46 Millimoles per Liter
Standard Error 0.041
|
-0.37 Millimoles per Liter
Standard Error 0.041
|
-0.45 Millimoles per Liter
Standard Error 0.042
|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours
MC from BL, K, 0-4h
|
-0.42 Millimoles per Liter
Standard Error 0.042
|
-0.44 Millimoles per Liter
Standard Error 0.041
|
-0.25 Millimoles per Liter
Standard Error 0.041
|
-0.39 Millimoles per Liter
Standard Error 0.042
|
-0.25 Millimoles per Liter
Standard Error 0.041
|
-0.36 Millimoles per Liter
Standard Error 0.042
|
|
Minimum Change From Baseline (Pre-dose on Day 1) in Potassium Over 4 and 27 Hours and Weighted Mean Change From Baseline in Potassium Over 4 Hours
WMC from BL, K, 0-4h
|
-0.18 Millimoles per Liter
Standard Error 0.042
|
-0.22 Millimoles per Liter
Standard Error 0.040
|
-0.06 Millimoles per Liter
Standard Error 0.040
|
-0.17 Millimoles per Liter
Standard Error 0.041
|
-0.07 Millimoles per Liter
Standard Error 0.041
|
-0.14 Millimoles per Liter
Standard Error 0.042
|
SECONDARY outcome
Timeframe: From dosing until 4 hours (0-4h)Population: Modified Per Protocol population. n=data is presented for the participants available at the time of assessment.
Analysis of QT (B) or QTc (F) interval during ECG (taken in supine position) was performed using Bazett's method and Fridericia's method, respectively. Heart rate, BP, potassium, and glucose were measured in supine body position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data.
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=38 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
Heart rate
|
1.850 hours
Interval 0.88 to 4.0
|
1.850 hours
Interval 0.88 to 4.0
|
1.517 hours
Interval 0.87 to 3.98
|
1.517 hours
Interval 0.88 to 4.0
|
1.567 hours
Interval 0.88 to 3.98
|
1.567 hours
Interval 0.87 to 4.17
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
Systlic BP
|
0.917 hours
Interval 0.87 to 3.98
|
2.100 hours
Interval 0.87 to 3.98
|
2.100 hours
Interval 0.9 to 3.98
|
2.100 hours
Interval 0.88 to 3.98
|
2.008 hours
Interval 0.87 to 3.98
|
3.008 hours
Interval 0.88 to 4.17
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
Diastolic BP
|
2.100 hours
Interval 0.87 to 3.97
|
1.967 hours
Interval 0.87 to 3.98
|
2.100 hours
Interval 0.87 to 4.02
|
0.933 hours
Interval 0.83 to 3.98
|
1.983 hours
Interval 0.88 to 3.97
|
0.925 hours
Interval 0.88 to 3.98
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
QTcF
|
2.183 hours
Interval 0.83 to 3.98
|
2.100 hours
Interval 0.87 to 3.95
|
2.167 hours
Interval 0.83 to 4.03
|
2.100 hours
Interval 0.83 to 3.98
|
2.133 hours
Interval 0.63 to 4.0
|
2.117 hours
Interval 0.83 to 4.1
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
QTcB
|
2.100 hours
Interval 0.83 to 3.98
|
2.100 hours
Interval 0.87 to 3.95
|
2.100 hours
Interval 0.83 to 4.03
|
2.100 hours
Interval 0.83 to 3.98
|
2.100 hours
Interval 0.63 to 4.0
|
2.100 hours
Interval 0.83 to 4.1
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
Glucose
|
1.933 hours
Interval 0.92 to 4.0
|
1.950 hours
Interval 0.92 to 4.03
|
0.967 hours
Interval 0.9 to 4.0
|
0.967 hours
Interval 0.9 to 4.08
|
1.150 hours
Interval 0.92 to 4.03
|
0.967 hours
Interval 0.92 to 4.02
|
|
Time to Maximum Change From Baseline (Pre-dose on Day 1) for QTc(B), QTc(F), Heart Rate, Systolic BP, Glucose in Supine Position and Time to Minimum Change From Baseline for Potassium and Diastolic BP in Supine Position
Potassium
|
1.967 hours
Interval 0.92 to 4.43
|
1.933 hours
Interval 0.92 to 4.03
|
1.933 hours
Interval 0.92 to 4.0
|
1.950 hours
Interval 0.9 to 4.02
|
1.942 hours
Interval 0.88 to 4.05
|
1.933 hours
Interval 0.88 to 4.02
|
SECONDARY outcome
Timeframe: Up to 82 daysPopulation: Pharmacokinetic (PK) population included participants in the 'All Subjects' population for whom a PK sample was obtained and analyzed following GSK961081 dosing. All participants were available at the time of analysis; however, for few participants, parameter cannot be derived because of non-quantifiable concentrations.
AUC(0-t) is the area under plasma concentration time curve of GSK961081 to the last quantifiable concentration. This parameter was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. A large proportion of AUC(0-t) and Cmax values were reported as not countable (NC) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. AUC(0-t) imputed with 1/2 lowest observed AUC(0-t), where lowest AUC(0-t) was 56.46 hour picograms per milliliter (h\*pg/mL).
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration Time Curve (AUC) of GSK961081 to the Last Quantifiable Concentration
|
NA h*pg/mL
Geometric Coefficient of Variation NA
Not applicable due to insufficient data to derive summary measure
|
233.93 h*pg/mL
Geometric Coefficient of Variation 139.0
|
NA h*pg/mL
Geometric Coefficient of Variation NA
Not applicable due to insufficient data to derive summary measure
|
216.22 h*pg/mL
Geometric Coefficient of Variation 131.3
|
NA h*pg/mL
Geometric Coefficient of Variation NA
Not applicable due to insufficient data to derive summary measure
|
229.51 h*pg/mL
Geometric Coefficient of Variation 128.6
|
SECONDARY outcome
Timeframe: Up to 82 daysPopulation: PK population. All participants were present for analysis, however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations.
Cmax is the Maximum observed concentration of GSK961081 determined directly from the concentration-time data. A large proportion of Cmax values were reported as not countable (NC ) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. Cmax was imputed with 1/2 lowest limit of quantification (LLQ), where LLQ was 25 picograms per milliliter (pg/mL).
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=41 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data
|
66.93 pg/mL
Geometric Coefficient of Variation 55.0
|
169.05 pg/mL
Geometric Coefficient of Variation 66.2
|
70.77 pg/mL
Geometric Coefficient of Variation 54.8
|
153.59 pg/mL
Geometric Coefficient of Variation 50.5
|
70.52 pg/mL
Geometric Coefficient of Variation 60.9
|
176.92 pg/mL
Geometric Coefficient of Variation 47.9
|
SECONDARY outcome
Timeframe: Up to 82 daysPopulation: PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentrations. Data is presented for the participants available at the time of assessment.
Tmax is the time to maximum plasma concentration of GSK961081 over period determined directly from the concentration-time data
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=38 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of GSK961081 Over Period Determined Directly From the Concentration-time Data
|
0.920 Hours
Interval 0.9 to 1.97
|
0.930 Hours
Interval 0.9 to 2.08
|
0.925 Hours
Interval 0.9 to 1.97
|
0.920 Hours
Interval 0.9 to 1.97
|
0.920 Hours
Interval 0.83 to 2.02
|
0.920 Hours
Interval 0.83 to 1.93
|
SECONDARY outcome
Timeframe: Up to 82 daysPopulation: PK population. All participants were present for the analysis; however, there were few participants for whom parameter could not be derived because of non-quantifiable concentration. Data is presented for the participants available at the time of assessment.
Tlast is the time to last quantifiable plasma concentration of GSK961081 over period determined directly from the concentration-time data
Outcome measures
| Measure |
GSK961081 400 mg Plus SAL
n=38 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus SAL
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus IPR
n=40 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus IPR
n=41 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
GSK961081 400 mg Plus Placebo
n=39 Participants
Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
GSK961081 1200 mg Plus Placebo
n=39 Participants
Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Time to Last Quantifiable Plasma Concentration (Tlast) of GSK961081 Over Period Determined Directly From the Concentration-time Data
|
0.960 hours
Interval 0.9 to 4.02
|
2.000 hours
Interval 0.92 to 23.95
|
1.930 hours
Interval 0.92 to 11.95
|
3.920 hours
Interval 0.92 to 23.97
|
1.920 hours
Interval 0.83 to 4.0
|
2.050 hours
Interval 0.92 to 11.98
|
Adverse Events
400 Microgrammes GSK961081 and Salbutamol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
1200 Microgrammes GSK961081 and Salbutamol
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
400 Microgrammes GSK961081 and Ipratropium Bromide
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
1200 Microgrammes of GSK961081 and Ipratropium Bromide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
400 Microgrammes of GSK961081 and Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1200 Microgrammes of GSK961081 and Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
400 Microgrammes GSK961081 and Salbutamol
n=39 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
1200 Microgrammes GSK961081 and Salbutamol
n=41 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
400 Microgrammes GSK961081 and Ipratropium Bromide
n=41 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
1200 Microgrammes of GSK961081 and Ipratropium Bromide
n=41 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
400 Microgrammes of GSK961081 and Placebo
n=40 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
1200 Microgrammes of GSK961081 and Placebo
n=39 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
Other adverse events
| Measure |
400 Microgrammes GSK961081 and Salbutamol
n=39 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
1200 Microgrammes GSK961081 and Salbutamol
n=41 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
|
400 Microgrammes GSK961081 and Ipratropium Bromide
n=41 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
1200 Microgrammes of GSK961081 and Ipratropium Bromide
n=41 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
|
400 Microgrammes of GSK961081 and Placebo
n=40 participants at risk
400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
1200 Microgrammes of GSK961081 and Placebo
n=39 participants at risk
1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.8%
5/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
12.2%
5/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
9.8%
4/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
9.8%
4/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
7.7%
3/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Tremor
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
4.9%
2/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
4.9%
2/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
5.1%
2/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
7.3%
3/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
7.3%
3/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
General disorders
Application site erythema
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
General disorders
Application site rash
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
General disorders
Application site vesicles
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.5%
1/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
2.4%
1/41 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/40 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
0.00%
0/39 • Up to 82 days
All Subjects population included all participants who received at least one dose of the study drug.
|
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