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An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00674817
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : March 27, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: 400 microgrammes GSK961081
Drug: 1200 microgrammes GSK961081
Enrollment 45
Recruitment Details 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.
Pre-assignment Details A total of 44 participants were screened over period of 28 days and were enrolled in the study.
Arm/Group Title Total Population
Hide Arm/Group Description 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 Title: Period 1
Started 44
Completed 41
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Protocol Violation             1
Period Title: Period 2
Started 41
Completed 41
Not Completed 0
Period Title: Period 3
Started 41
Completed 39
Not Completed 2
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Period Title: Period 4
Started 39
Completed 38
Not Completed 1
Reason Not Completed
Adverse Event             1
Period Title: Period 5
Started 38
Completed 38
Not Completed 0
Period Title: Period 6
Started 38
Completed 38
Not Completed 0
Arm/Group Title Total Population
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
All subjects population included all participants who received at least one dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 44 participants
63.1  (6.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
8
  18.2%
Male
36
  81.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Asian - South East Asian Heritage 22
Native Hawaiian or other Pacific Islander 1
White - White/Caucasian/European Heritage 21
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1 hour Number Analyzed 39 participants 41 participants 40 participants 40 participants 37 participants 37 participants
0.111  (0.0146) 0.113  (0.0142) 0.087  (0.0144) 0.111  (0.0144) 0.072  (0.0144) 0.094  (0.0149)
12 hour Number Analyzed 39 participants 40 participants 40 participants 40 participants 40 participants 38 participants
0.141  (0.0173) 0.134  (0.0170) 0.127  (0.0170) 0.098  (0.0171) 0.002  (0.0170) 0.043  (0.0174)
24 hour Number Analyzed 39 participants 40 participants 41 participants 39 participants 40 participants 37 participants
0.161  (0.0166) 0.175  (0.0163) 0.179  (0.0162) 0.172  (0.0166) 0.039  (0.0163) 0.049  (0.0169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.020
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.039
Confidence Interval (2-Sided) 90%
0.008 to 0.069
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0187
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.139
Confidence Interval (2-Sided) 90%
0.101 to 0.176
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0227
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.123
Confidence Interval (2-Sided) 90%
0.087 to 0.158
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0217
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.220
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.014
Confidence Interval (2-Sided) 90%
-0.016 to 0.045
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0185
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.124
Confidence Interval (2-Sided) 90%
0.087 to 0.161
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0225
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.141
Confidence Interval (2-Sided) 90%
0.105 to 0.176
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0214
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.019
Confidence Interval (2-Sided) 90%
-0.012 to 0.050
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0188
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.091
Confidence Interval (2-Sided) 90%
0.053 to 0.129
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0229
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.126
Confidence Interval (2-Sided) 90%
0.090 to 0.162
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0220
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.017
Confidence Interval (2-Sided) 90%
-0.015 to 0.048
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0190
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.009
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.055
Confidence Interval (2-Sided) 90%
0.017 to 0.093
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0230
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.122
Confidence Interval (2-Sided) 90%
0.086 to 0.159
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0222
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Modified per protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1 hour Number Analyzed 39 participants 41 participants 40 participants 40 participants 40 participants 37 participants
0.169  (0.0460) 0.281  (0.0449) 0.167  (0.0454) 0.207  (0.0454) 0.234  (0.0454) 0.229  (0.0472)
12 hour Number Analyzed 39 participants 40 participants 40 participants 40 participants 40 participants 38 participants
0.160  (0.0380) 0.182  (0.0375) 0.188  (0.0375) 0.223  (0.0375) 0.068  (0.0375) 0.088  (0.0385)
24 hour Number Analyzed 39 participants 40 participants 41 participants 39 participants 40 participants 37 participants
0.247  (0.0398) 0.205  (0.0392) 0.279  (0.0388) 0.214  (0.0397) 0.179  (0.0393) 0.113  (0.0407)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.856
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.066
Confidence Interval (2-Sided) 90%
-0.168 to 0.036
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0616
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.033
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.092
Confidence Interval (2-Sided) 90%
0.010 to 0.174
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0496
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.099
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.068
Confidence Interval (2-Sided) 90%
-0.019 to 0.154
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0523
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.862
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.067
Confidence Interval (2-Sided) 90%
-0.168 to 0.034
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0612
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.008
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.120
Confidence Interval (2-Sided) 90%
0.039 to 0.201
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0493
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.100
Confidence Interval (2-Sided) 90%
0.015 to 0.185
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0516
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.200
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.052
Confidence Interval (2-Sided) 90%
-0.050 to 0.155
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0621
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.031
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.094
Confidence Interval (2-Sided) 90%
0.011 to 0.177
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0500
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.043
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.092
Confidence Interval (2-Sided) 90%
0.004 to 0.179
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0530
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.637
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.022
Confidence Interval (2-Sided) 90%
-0.125 to 0.081
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0625
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.136
Confidence Interval (2-Sided) 90%
0.053 to 0.218
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0500
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.031
Comments [Not Specified]
Method Mix model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.100
Confidence Interval (2-Sided) 90%
0.012 to 0.189
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0534
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events
Hide Description 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.
Time Frame Upto 82 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 41 40 39
Measure Type: Number
Unit of Measure: Participants
Participants with any AE 13 13 15 9 6 11
Participants with any SAE 0 1 1 0 0 0
4.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities of Potential Clinical Concern (PCC)
Hide Description 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).
Time Frame Up to 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 41 40 39
Measure Type: Number
Unit of Measure: Participants
Hemoglobin high 0 1 0 0 0 0
Platelets high 0 1 0 0 0 0
Platelets low 1 0 0 0 0 0
Lymphocytes low 0 0 0 1 0 0
5.Secondary Outcome
Title Change From Baseline (Pre-dose on Day 1) in Systolic and Diastolic Blood Pressure up to 27 Hours
Hide Description 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.
Time Frame Up to 27 hours post Day 1 dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 41 40 39
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mm of Hg)
SBP, 1 hour(h) Number Analyzed 39 participants 41 participants 41 participants 41 participants 40 participants 39 participants
-1.33  (12.321) 3.10  (11.115) 0.61  (10.703) -1.73  (10.301) -0.13  (12.096) -0.33  (11.235)
SBP, 2h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 39 participants
-3.41  (10.918) 1.22  (10.741) 3.49  (7.919) 2.33  (11.450) 1.03  (8.195) 1.31  (12.131)
SBP, 4h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-2.36  (8.963) 4.20  (12.107) 3.27  (9.680) 2.68  (9.689) 0.63  (10.947) 2.38  (10.101)
SBP, 9h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-0.87  (12.064) 3.08  (10.598) 1.07  (10.900) 2.71  (12.125) 0.00  (9.748) 2.95  (12.237)
SBP, 12h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-3.49  (11.850) 2.08  (15.895) -0.46  (11.145) 0.32  (12.445) -1.95  (11.618) -0.51  (10.450)
SBP, 13h Number Analyzed 37 participants 39 participants 41 participants 41 participants 40 participants 38 participants
-5.62  (11.947) 3.46  (13.742) 1.05  (11.866) 2.27  (13.808) 3.45  (15.591) 2.21  (9.935)
SBP, 24h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-3.31  (12.092) 4.65  (10.843) 1.41  (11.469) 2.56  (12.616) -1.50  (10.627) 1.68  (10.547)
SBP, 25h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 37 participants
-3.38  (11.679) 4.05  (14.022) 2.32  (13.083) 2.44  (9.453) -0.10  (12.349) 1.49  (11.428)
SBP, 27h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-5.59  (9.999) 2.43  (11.670) -3.24  (11.432) -0.32  (12.875) -3.25  (10.463) -1.24  (10.899)
DBP, 1h Number Analyzed 39 participants 41 participants 40 participants 41 participants 40 participants 39 participants
-1.59  (6.754) -1.41  (6.340) 1.25  (8.002) -2.66  (6.814) 0.55  (6.737) -2.21  (8.594)
DBP, 2h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 39 participants
-4.15  (7.744) -2.27  (7.871) 0.07  (7.438) 0.48  (6.939) -1.48  (6.473) -1.05  (7.189)
DBP, 4h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-0.26  (6.332) 1.23  (6.078) 1.24  (6.689) 0.12  (8.134) 1.38  (8.350) 1.54  (6.353)
DBP, 9h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-1.59  (7.923) 0.03  (7.882) -1.73  (7.820) -0.34  (9.175) 0.28  (6.373) -0.79  (8.581)
DBP, 12h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-3.18  (8.742) -1.25  (7.655) -2.68  (8.329) -0.90  (7.605) -3.05  (7.414) -0.51  (7.026)
DBP, 13h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-4.19  (11.638) -1.97  (7.856) -0.56  (8.152) -0.39  (7.602) 0.85  (9.670) -0.34  (8.380)
DBP, 24h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-0.95  (6.411) 3.13  (8.624) 0.37  (5.634) 2.32  (7.932) -0.23  (6.799) -0.58  (7.310)
DBP, 25h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 37 participants
-2.26  (6.976) 0.75  (7.171) 1.24  (8.166) 1.49  (8.474) 0.78  (5.753) 2.22  (7.536)
DBP, 27h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-3.28  (7.229) -0.03  (8.192) -2.51  (7.871) -1.12  (7.541) -3.35  (9.270) -1.55  (7.202)
6.Secondary Outcome
Title Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate Over 27 Hours
Hide Description 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.
Time Frame Up to 27 hours post Day 1 dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 41 40 39
Mean (Standard Deviation)
Unit of Measure: Beats per minute
1h Number Analyzed 39 participants 41 participants 41 participants 41 participants 40 participants 39 participants
-2.56  (10.246) -1.37  (8.546) -3.90  (7.761) -2.27  (7.099) -3.55  (9.047) -3.10  (6.585)
1h 15 minutes Number Analyzed 39 participants 41 participants 41 participants 41 participants 40 participants 38 participants
-0.95  (8.712) -0.46  (7.328) -2.80  (7.118) -0.15  (6.624) -4.03  (7.540) -1.74  (5.915)
1h 35 minutes Number Analyzed 39 participants 41 participants 41 participants 41 participants 40 participants 38 participants
-0.03  (8.481) 1.51  (7.166) -2.34  (7.275) -0.98  (5.943) -3.63  (6.717) -2.36  (6.098)
1h 55 minutes Number Analyzed 39 participants 41 participants 41 participants 41 participants 40 participants 38 participants
3.21  (9.359) 4.54  (7.246) -3.46  (7.232) -0.39  (6.629) -3.63  (6.636) -2.21  (6.420)
4h Number Analyzed 38 participants 40 participants 41 participants 41 participants 40 participants 39 participants
-0.71  (11.094) 1.13  (6.501) -3.59  (9.389) -1.78  (6.031) -4.75  (6.636) -3.97  (7.069)
9h Number Analyzed 39 participants 39 participants 41 participants 41 participants 40 participants 39 participants
1.92  (6.247) 2.97  (6.815) -1.66  (7.529) 1.37  (7.569) -0.70  (8.879) 0.28  (7.215)
12h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 39 participants
1.95  (7.567) 3.65  (8.469) 1.46  (8.521) 2.83  (7.752) 2.68  (8.689) 1.87  (6.993)
12h 15 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
3.95  (7.729) 5.35  (7.608) 1.83  (6.364) 4.10  (7.612) 1.80  (6.992) 2.05  (8.220)
12h 35 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
4.97  (7.741) 6.90  (7.558) 1.51  (6.856) 3.41  (8.465) 2.28  (6.520) 1.29  (6.534)
12h 55 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
5.79  (8.694) 6.50  (8.124) 1.07  (7.424) 1.90  (7.671) 0.98  (7.416) 1.37  (8.065)
24h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-2.36  (8.142) -1.08  (7.145) -3.24  (5.267) -1.85  (7.189) -3.63  (8.079) -4.55  (7.576)
24h 15 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
-1.49  (8.705) -1.60  (7.938) -0.83  (7.297) -0.98  (7.666) -2.95  (6.972) -4.03  (8.284)
24h 35 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
0.23  (8.806) 0.53  (7.990) -2.93  (6.218) -1.02  (6.901) -4.48  (6.361) -4.63  (6.724)
24h 55 minutes Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
1.05  (8.617) 0.83  (8.650) -2.46  (9.223) -2.05  (6.488) -4.13  (7.198) -4.21  (7.037)
27h Number Analyzed 39 participants 40 participants 41 participants 41 participants 40 participants 38 participants
6.74  (9.402) 6.38  (9.440) 1.17  (9.132) 4.44  (9.394) 2.05  (7.968) 2.68  (8.817)
7.Secondary Outcome
Title Number of Participants With Maximum Change From Baseline 12-LED Electrocardiogram (ECG) Findings
Hide Description 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.
Time Frame From dosing until 24h post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects population
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 41 40 39
Measure Type: Number
Unit of Measure: Participants
QTcB, <=30 msec 26 31 35 33 36 31
QTcB, >30 to <= 59 msec 12 9 6 7 3 6
QTcB, >=60 msec 1 1 0 1 1 2
QTcF, <=30 msec 34 31 37 36 36 35
QTcF, >30 to <= 59 msec 5 9 2 4 4 2
QTcF, >=60 msec 0 1 2 1 0 2
8.Secondary Outcome
Title Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 4 Hours After Dosing
Hide Description 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.
Time Frame From dosing until 4 hours (0-4h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified per protocol population
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Mean (Standard Deviation)
Unit of Measure: msec
14.34  (1.865) 14.98  (1.827) 12.31  (1.824) 11.99  (1.839) 10.60  (1.844) 13.22  (1.890)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.747
Confidence Interval (2-Sided) 95%
-0.547 to 8.041
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1768
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.712
Confidence Interval (2-Sided) 95%
-2.521 to 5.944
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1453
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.755
Confidence Interval (2-Sided) 95%
-2.559 to 6.069
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1869
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.231
Confidence Interval (2-Sided) 95%
-5.565 to 3.103
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1970
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Maximum Change From Baseline (Pre-dose on Day 1) in QTc (F) in Supine Position From 0 to 27 Hours After Dosing
Hide Description 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 .
Time Frame From dosing until 27 hours (0-27h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified per protocol population
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Mean (Standard Deviation)
Unit of Measure: msec
19.70  (2.152) 19.53  (2.104) 17.41  (2.100) 17.45  (2.119) 15.14  (2.125) 18.60  (2.184)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.558
Confidence Interval (2-Sided) 95%
-0.781 to 9.897
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7064
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.266
Confidence Interval (2-Sided) 95%
-2.999 to 7.532
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6691
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.930
Confidence Interval (2-Sided) 95%
-4.429 to 6.290
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7170
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.152
Confidence Interval (2-Sided) 95%
-6.539 to 4.236
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7310
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(F) in Supine Position From 0 to 4 Hours
Hide Description 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.
Time Frame From dosing until 4 hours (0-4h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified per protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 37
Least Squares Mean (Standard Deviation)
Unit of Measure: msec
5.42  (1.565) 7.53  (1.536) 4.59  (1.535) 6.23  (1.546) 4.17  (1.549) 8.18  (1.597)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.249
Confidence Interval (2-Sided) 95%
-2.069 to 4.566
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6816
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.418
Confidence Interval (2-Sided) 95%
-2.850 to 3.687
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6565
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.650
Confidence Interval (2-Sided) 95%
-4.013 to 2.714
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7050
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.949
Confidence Interval (2-Sided) 95%
-5.325 to 1.427
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7112
Estimation Comments [Not Specified]
11.Secondary Outcome
Title 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
Hide Description 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 .
Time Frame From dosing until 4 hours (0-4h) and 27 hours (0-27h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: msec
0-4 hours 16.70  (2.078) 19.51  (2.035) 9.19  (2.033) 10.77  (2.047) 6.50  (2.054) 11.65  (2.109)
0-27 hours 24.17  (2.390) 25.88  (2.339) 17.33  (2.337) 17.83  (2.353) 12.94  (2.362) 19.91  (2.429)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.198
Confidence Interval (2-Sided) 95%
5.258 to 15.139
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5039
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.686
Confidence Interval (2-Sided) 95%
-2.195 to 7.567
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4738
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.854
Confidence Interval (2-Sided) 95%
2.883 to 12.825
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5196
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.884
Confidence Interval (2-Sided) 95%
-5.864 to 4.097
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.5244
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.227
Confidence Interval (2-Sided) 95%
5.352 to 17.103
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9782
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.390
Confidence Interval (2-Sided) 95%
-1.418 to 10.197
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9434
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.975
Confidence Interval (2-Sided) 95%
0.065 to 11.886
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.9958
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.083
Confidence Interval (2-Sided) 95%
-8.006 to 3.840
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.0023
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Weighted Mean Change From Baseline (Pre-dose on Day 1) in QTc(B) in Supine Position From 0 to 4 Hours
Hide Description 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.
Time Frame From dosing until 4 hours (0-4h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 37
Least Squares Mean (Standard Error)
Unit of Measure: msec
5.27  (1.569) 9.08  (1.542) 0.08  (1.542) 4.44  (1.550) 0.07  (1.555) 6.12  (1.602)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.200
Confidence Interval (2-Sided) 95%
1.857 to 8.542
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6941
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.007
Confidence Interval (2-Sided) 95%
-3.294 to 3.307
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6727
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.956
Confidence Interval (2-Sided) 95%
-0.433 to 6.345
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7178
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.683
Confidence Interval (2-Sided) 95%
-5.076 to 1.711
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7199
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Maximum Change From Baseline (Pre-dose on Day 1) in Supine Heart Rate From 0 to 4 Hours and From 0 to 27 Hours.
Hide Description 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.
Time Frame From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Beats per minute
0-4 h 7.51  (1.125) 7.90  (1.099) 2.18  (1.097) 3.17  (1.109) 0.92  (1.110) 0.92  (1.139)
0-27 h 13.33  (1.011) 12.92  (0.988) 9.49  (0.987) 10.28  (0.998) 9.21  (0.998) 8.66  (1.024)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.588
Confidence Interval (2-Sided) 95%
3.839 to 9.336
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3932
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.255
Confidence Interval (2-Sided) 95%
-1.453 to 3.962
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3725
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.985
Confidence Interval (2-Sided) 95%
4.231 to 9.738
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3960
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.255
Confidence Interval (2-Sided) 95%
-0.522 to 5.031
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.4077
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.121
Confidence Interval (2-Sided) 95%
1.662 to 6.580
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2464
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.280
Confidence Interval (2-Sided) 95%
-2.142 to 2.703
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2278
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.266
Confidence Interval (2-Sided) 95%
1.802 to 6.729
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2490
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.621
Confidence Interval (2-Sided) 95%
-0.863 to 4.106
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2593
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Weighted Mean Change From Baseline (Pre-dose on Day 1) in Heart Rate in Supine Position From 0 to 4 Hours
Hide Description 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.
Time Frame From dosing until 4 hours (0-4h)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population. Data is presented for the participants available at the time of assessment.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 37
Least Squares Mean (Standard Error)
Unit of Measure: Beats per minute
0.52  (0.729) 1.77  (0.713) -2.93  (0.714) -1.27  (0.720) -3.57  (0.721) -2.21  (0.745)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.094
Confidence Interval (2-Sided) 95%
2.456 to 5.732
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8300
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.646
Confidence Interval (2-Sided) 95%
-0.967 to 2.258
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8172
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.980
Confidence Interval (2-Sided) 95%
2.324 to 5.636
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8395
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.934
Confidence Interval (2-Sided) 95%
-0.735 to 2.603
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8460
Estimation Comments [Not Specified]
15.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Millimeters of mercury
MC from BL,SBP,0-4h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 38 participants
5.61  (1.452) 8.06  (1.409) 8.05  (1.394) 5.55  (1.414) 7.45  (1.412) 7.74  (1.448)
MC from BL,SBP,0-27h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 38 participants
10.89  (1.530) 15.93  (1.488) 14.08  (1.477) 12.87  (1.495) 14.16  (1.493) 14.10  (1.527)
WMC from BL SBP,0-4h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 37 participants
-0.34  (1.103) 0.92  (1.071) 2.24  (1.063) 0.10  (1.076) 1.06  (1.075) 0.82  (1.113)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.836
Confidence Interval (2-Sided) 95%
-5.420 to 1.748
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8168
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.599
Confidence Interval (2-Sided) 95%
-2.914 to 4.113
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7809
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.324
Confidence Interval (2-Sided) 95%
-3.261 to 3.909
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8174
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.182
Confidence Interval (2-Sided) 95%
-5.781 to 1.416
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8242
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.266
Confidence Interval (2-Sided) 95%
-6.762 to 0.230
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7723
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.077
Confidence Interval (2-Sided) 95%
-3.502 to 3.348
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7361
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.827
Confidence Interval (2-Sided) 95%
-1.673 to 5.327
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7743
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.232
Confidence Interval (2-Sided) 95%
-4.743 to 2.279
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7800
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.394
Confidence Interval (2-Sided) 95%
-3.976 to 1.187
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3084
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.181
Confidence Interval (2-Sided) 95%
-1.348 to 3.710
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2819
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.106
Confidence Interval (2-Sided) 95%
-2.498 to 2.710
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3201
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.713
Confidence Interval (2-Sided) 95%
-3.325 to 1.899
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3241
Estimation Comments [Not Specified]
16.Secondary Outcome
Title 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
Hide Description 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 .
Time Frame 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Millimeters of mercury
MC from BL, DBP, 0-4h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 38 participants
-5.53  (0.971) -5.76  (0.946) -3.26  (0.942) -5.49  (0.954) -4.96  (0.954) -4.42  (0.979)
MC from BL, DBP, 0-27h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 38 participants
-10.04  (0.953) -9.20  (0.930) -9.12  (0.928) -8.72  (0.938) -9.66  (0.938) -9.18  (0.959)
WMC from BL, DBP, 0-4h Number Analyzed 39 participants 41 participants 41 participants 40 participants 40 participants 37 participants
-1.30  (0.733) -1.25  (0.715) 0.75  (0.713) -0.80  (0.721) -0.12  (0.721) -0.44  (0.747)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.561
Confidence Interval (2-Sided) 95%
-2.997 to 1.876
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2351
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.705
Confidence Interval (2-Sided) 95%
-0.687 to 4.097
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2125
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.337
Confidence Interval (2-Sided) 95%
-3.771 to 1.098
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2341
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.067
Confidence Interval (2-Sided) 95%
-3.516 to 1.382
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2416
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.376
Confidence Interval (2-Sided) 95%
-2.545 to 1.794
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0997
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.540
Confidence Interval (2-Sided) 95%
-1.588 to 2.668
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0786
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.016
Confidence Interval (2-Sided) 95%
-2.185 to 2.154
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.0999
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.466
Confidence Interval (2-Sided) 95%
-1.715 to 2.648
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1058
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.180
Confidence Interval (2-Sided) 95%
-2.918 to 0.559
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8810
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.876
Confidence Interval (2-Sided) 95%
-0.829 to 2.582
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8644
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.809
Confidence Interval (2-Sided) 95%
-2.561 to 0.944
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8882
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.360
Confidence Interval (2-Sided) 95%
-2.122 to 1.401
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8929
Estimation Comments [Not Specified]
17.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per Liter
MC from BL, Glu, 0-4h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 38 participants
0.66  (0.186) 0.53  (0.182) 0.52  (0.182) 0.53  (0.186) 0.13  (0.184) 0.22  (0.189)
MC from BL, Glu, 0-27h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 38 participants
2.71  (0.236) 2.13  (0.230) 1.78  (0.230) 1.87  (0.235) 1.83  (0.232) 1.30  (0.239)
WMC from BL, Glu, 0-4h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 37 participants
0.02  (0.083) 0.02  (0.081) -0.12  (0.081) -0.08  (0.082) -0.29  (0.082) 0.19  (0.085)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.530
Confidence Interval (2-Sided) 95%
0.066 to 0.994
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2352
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.388
Confidence Interval (2-Sided) 95%
-0.069 to 0.846
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2318
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.309
Confidence Interval (2-Sided) 95%
-0.157 to 0.775
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2363
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.309
Confidence Interval (2-Sided) 95%
-0.163 to 0.780
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2392
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.874
Confidence Interval (2-Sided) 95%
0.262 to 1.485
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3099
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.053
Confidence Interval (2-Sided) 95%
-0.656 to 0.550
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3056
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.829
Confidence Interval (2-Sided) 95%
0.215 to 1.443
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3112
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.567
Confidence Interval (2-Sided) 95%
-0.054 to 1.189
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3151
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.312
Confidence Interval (2-Sided) 95%
0.110 to 0.513
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1021
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.173
Confidence Interval (2-Sided) 95%
-0.025 to 0.372
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1006
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.210
Confidence Interval (2-Sided) 95%
0.006 to 0.414
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1035
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.104
Confidence Interval (2-Sided) 95%
-0.103 to 0.311
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1047
Estimation Comments [Not Specified]
18.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Per Protocol population. Only those participants available at the specified time points were analyzed.
Arm/Group Title GSK961081 400 mg Plus SAL GSK961081 1200 mg Plus SAL GSK961081 400 mg Plus IPR GSK961081 1200 mg Plus IPR GSK961081 400 mg Plus Placebo GSK961081 1200 mg Plus Placebo
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 39 41 41 40 40 38
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per Liter
MC from BL, K, 0-4h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 38 participants
-0.42  (0.042) -0.44  (0.041) -0.25  (0.041) -0.39  (0.042) -0.25  (0.041) -0.36  (0.042)
MC from BL, K, 0-27h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 38 participants
-0.53  (0.042) -0.62  (0.040) -0.42  (0.041) -0.46  (0.041) -0.37  (0.041) -0.45  (0.042)
WMC from BL, K, 0-4h Number Analyzed 39 participants 41 participants 41 participants 39 participants 40 participants 37 participants
-0.18  (0.042) -0.22  (0.040) -0.06  (0.040) -0.17  (0.041) -0.07  (0.041) -0.14  (0.042)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.177
Confidence Interval (2-Sided) 95%
-0.276 to -0.078
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0503
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus IPR, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.001
Confidence Interval (2-Sided) 95%
-0.096 to 0.097
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0490
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus SAL, GSK961081 1200 mg Plus Placebo
Comments SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.076
Confidence Interval (2-Sided) 95%
-0.174 to 0.022
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0498
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK961081 1200 mg Plus IPR, GSK961081 1200 mg Plus Placebo
Comments GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.028
Confidence Interval (2-Sided) 95%
-0.128 to 0.072
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0507
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK961081 400 mg Plus SAL, GSK961081 400 mg Plus Placebo
Comments GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours
Type of