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A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal Therapy.

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ClinicalTrials.gov Identifier: NCT00603382
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : August 19, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: GW685698X
Drug: Placebo
Enrollment 599
Recruitment Details  
Pre-assignment Details Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline, safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. Total 1459 par. were screened, 601 were randomized of which 598 par. received at least one dose of study treatment.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Period Title: Overall Study
Started 94 97 100 110 95 102
Completed 76 83 91 98 86 84
Not Completed 18 14 9 12 9 18
Reason Not Completed
Adverse Event             0             1             1             2             1             2
Lack of Efficacy             14             9             3             6             6             11
Protocol Violation             1             0             1             2             1             0
Lost to Follow-up             0             1             1             1             0             1
Physician Decision             0             0             2             0             1             3
Withdrawal by Subject             3             3             1             1             0             1
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID Total
Hide Arm/Group Description Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 94 97 100 110 95 102 598
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 97 participants 100 participants 110 participants 95 participants 102 participants 598 participants
39.2  (15.82) 37.7  (15.40) 38.3  (14.49) 36.8  (15.56) 40.7  (15.96) 39.9  (15.03) 38.7  (15.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 97 participants 100 participants 110 participants 95 participants 102 participants 598 participants
Female
47
  50.0%
57
  58.8%
59
  59.0%
60
  54.5%
60
  63.2%
56
  54.9%
339
  56.7%
Male
47
  50.0%
40
  41.2%
41
  41.0%
50
  45.5%
35
  36.8%
46
  45.1%
259
  43.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 97 participants 100 participants 110 participants 95 participants 102 participants 598 participants
African American/African Heritage (AA/AHER) 5 4 4 8 6 5 32
American Indian or Alaska Native 5 7 5 6 6 5 34
Asian 7 13 9 10 10 10 59
White 69 64 72 76 64 74 419
AA/AHER & American Indian or Alaska Native 0 0 0 0 1 0 1
American Indian or Alaska Native & White 8 8 9 10 8 8 51
Native Hawaiian or other Pacific Islander & White 0 1 1 0 0 0 2
1.Primary Outcome
Title Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1(the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 93 94 97 109 94 101
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.137  (0.0428) 0.239  (0.0428) 0.266  (0.0420) 0.341  (0.0396) 0.367  (0.0428) 0.243  (0.0411)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 25 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.101
Confidence Interval (2-Sided) 95%
-0.018 to 0.221
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 50 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.129
Confidence Interval (2-Sided) 95%
0.011 to 0.247
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 100 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.204
Confidence Interval (2-Sided) 95%
0.089 to 0.319
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW685698X 200 µg OD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.230
Confidence Interval (2-Sided) 95%
0.111 to 0.349
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, FP 100 µg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.106
Confidence Interval (2-Sided) 95%
-0.010 to 0.223
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period
Hide Description PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 96 98 110 95 102
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
9.6  (4.21) 23.6  (4.17) 30.3  (4.12) 25.7  (3.90) 31.3  (4.20) 24.4  (4.04)
3.Secondary Outcome
Title Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period
Hide Description PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at th end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 96 98 110 95 102
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
13.6  (4.27) 27.2  (4.23) 33.5  (4.17) 29.5  (3.95) 35.6  (4.26) 25.6  (4.09)
4.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period
Hide Description Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 96 98 110 95 102
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of symptom-free 24-hr periods
18.4  (3.21) 25.3  (3.17) 31.1  (3.14) 38.7  (2.97) 31.7  (3.20) 33.3  (3.08)
5.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period
Hide Description The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.
Time Frame From Baseline up to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 96 98 110 95 102
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of rescue-free 24-hr periods
21.9  (3.32) 29.3  (3.28) 34.5  (3.24) 40.8  (3.08) 32.0  (3.31) 35.5  (3.18)
6.Secondary Outcome
Title Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
Hide Description The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.
Time Frame From the first dose of study medication up to Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Measure Type: Number
Unit of Measure: participants
14 9 3 6 6 11
7.Secondary Outcome
Title Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period
Hide Description An adverse event (AE) is defined as 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 adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.
Time Frame From the first dose of study medication up to Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Measure Type: Number
Unit of Measure: participants
Any AE 24 19 28 35 27 35
Any SAE 0 1 0 1 0 2
8.Secondary Outcome
Title Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis
Hide Description A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.
Time Frame From Baseline up to Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Measure Type: Number
Unit of Measure: participants
Clinical evidence 0 0 4 4 2 2
No clinical evidence 94 97 96 106 93 100
9.Secondary Outcome
Title Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Percentage
Basophils, BL, n=92, 94, 95, 106, 92, 97 0.31  (0.199) 0.32  (0.200) 0.31  (0.194) 0.32  (0.190) 0.33  (0.205) 0.33  (0.234)
Basophils,W8, n=72, 80, 83, 94, 82, 79 0.30  (0.186) 0.26  (0.153) 0.31  (0.169) 0.35  (0.236) 0.35  (0.220) 0.34  (0.264)
Eosinophils, BL, n=92, 94, 95, 106, 92, 97 3.87  (3.022) 3.38  (2.693) 3.95  (2.503) 4.40  (3.286) 4.75  (3.358) 3.88  (3.073)
Eosinophils, W8, n=72, 80, 83, 94, 82, 79 4.31  (3.544) 3.38  (3.300) 3.76  (2.608) 3.77  (3.066) 3.96  (2.867) 3.34  (2.364)
Lymphocytes, BL, n=92, 94, 95, 106, 92, 97 33.96  (8.378) 31.57  (8.821) 33.33  (7.768) 33.69  (8.682) 34.32  (8.806) 34.25  (8.514)
Lymphocytes, W8, n=72, 80, 83, 94, 82, 79 32.88  (8.063) 29.82  (10.120) 30.36  (8.322) 30.39  (7.326) 31.97  (7.440) 32.22  (7.877)
Monocytes, BL, n=92, 94, 95, 106, 92, 97 5.09  (2.379) 4.41  (1.851) 4.70  (2.056) 5.20  (2.113) 4.78  (2.301) 4.92  (2.093)
Monocytes, W8, n=72, 80, 83, 94, 82, 79 5.41  (3.042) 4.32  (2.098) 4.60  (2.486) 4.60  (2.178) 4.50  (2.174) 4.87  (2.380)
Total Neutrophils, BL, n=92, 94, 95, 106, 92, 97 56.74  (9.220) 60.24  (9.620) 57.68  (8.309) 56.34  (9.832) 55.80  (10.281) 56.60  (9.226)
Total Neutrophils, W8, n=72, 80, 83, 94, 82, 79 57.08  (9.543) 62.19  (11.580) 60.95  (9.008) 60.86  (8.054) 59.20  (8.881) 59.19  (8.672)
10.Secondary Outcome
Title Hematocrit at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Proportion of 1
Hematocrit, BL, n=92, 94, 95, 106, 92, 97 0.43  (0.041) 0.42  (0.039) 0.42  (0.040) 0.43  (0.043) 0.42  (0.039) 0.43  (0.034)
Hematocrit, W8, n=72, 79, 83, 94, 82, 79 0.43  (0.038) 0.42  (0.038) 0.42  (0.037) 0.43  (0.040) 0.42  (0.033) 0.43  (0.039)
11.Secondary Outcome
Title Hemoglobin at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Grams per liter (G/L)
Hemoglobin, BL, n=92, 94, 95, 106, 92, 96 141.54  (14.116) 138.05  (13.178) 140.70  (13.769) 141.14  (14.625) 139.50  (12.978) 141.90  (11.632)
Hemoglobin, W8, n=72, 79, 83, 94, 82, 79 140.81  (12.973) 137.86  (12.862) 138.95  (12.785) 140.16  (13.647) 136.32  (11.594) 139.81  (13.009)
12.Secondary Outcome
Title Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (GI/L)
Platelet count, BL, n=91, 91, 95, 106, 92, 95 271.68  (62.861) 265.75  (51.446) 279.38  (57.658) 272.20  (61.111) 268.37  (60.442) 281.26  (66.492)
Platelet count, W8, n=72, 76, 83, 93, 81, 78 265.47  (49.978) 262.07  (45.837) 271.03  (47.156) 278.57  (58.302) 272.53  (68.404) 274.46  (61.819)
WBC, BL, n=92, 94, 95, 106, 92, 97 7.82  (2.018) 7.96  (1.892) 8.01  (2.095) 7.62  (1.878) 7.79  (2.055) 7.94  (1.982)
WBC, W8, n=72, 79, 83, 94, 82, 79 7.56  (1.679) 8.26  (2.169) 8.34  (2.211) 7.94  (2.046) 7.94  (1.769) 8.00  (2.292)
13.Secondary Outcome
Title Red Blood Cells (RBC) Count at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (TI/L)
RBC, BL, n=92, 94, 95, 106, 92, 97 4.71  (0.429) 4.65  (0.438) 4.68  (0.425) 4.71  (0.460) 4.68  (0.422) 4.71  (0.416)
RBC, W8, n=72, 79, 83, 94, 82, 79 4.65  (0.410) 4.61  (0.445) 4.63  (0.435) 4.67  (0.450) 4.60  (0.369) 4.65  (0.462)
14.Secondary Outcome
Title Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALP, BL, n=94, 97, 99, 106, 94, 101 82.7  (36.11) 79.7  (32.21) 83.5  (40.07) 90.3  (56.43) 94.4  (71.94) 84.7  (62.31)
ALP, W8, n=78, 84, 90, 97, 85, 83 83.0  (40.83) 74.8  (27.91) 82.9  (41.61) 87.0  (49.65) 90.8  (76.22) 84.0  (59.81)
ALT, BL, n=94, 97, 99, 106, 94, 101 21.8  (15.91) 21.5  (14.57) 23.6  (19.40) 22.3  (16.61) 20.7  (11.38) 20.1  (9.84)
ALT, W8, n=78, 84, 90, 97, 86, 83 22.3  (22.79) 20.3  (11.92) 20.7  (10.39) 20.8  (14.01) 19.5  (12.03) 19.9  (10.04)
AST, BL, n=94, 96, 99, 105, 93, 101 21.0  (7.64) 22.8  (11.39) 22.8  (13.35) 21.9  (9.68) 21.3  (7.20) 20.3  (5.10)
AST, W8, n=78, 83, 90, 97, 86, 82 22.2  (10.76) 20.8  (6.48) 21.1  (7.52) 20.5  (8.07) 20.2  (5.91) 20.5  (5.38)
LD, BL, n=94, 96, 99, 105, 93, 101 157.9  (47.78) 170.7  (59.82) 169.3  (64.08) 165.6  (70.56) 172.9  (62.38) 164.2  (57.04)
LD, W8, n=78, 83, 90, 97, 86, 82 151.8  (32.37) 159.1  (31.46) 159.9  (32.14) 153.8  (26.90) 161.9  (36.79) 157.3  (27.36)
GGT, BL, n=94, 97, 99, 106, 94, 101 27.6  (20.00) 33.0  (30.67) 33.1  (31.42) 30.1  (22.29) 29.9  (26.30) 28.2  (21.40)
GGT, W8, n=78, 84, 90, 97, 86, 83 29.7  (27.53) 31.1  (24.61) 32.4  (30.84) 31.9  (24.96) 29.3  (32.75) 27.9  (21.24)
15.Secondary Outcome
Title Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Albumin,BL, n=94, 97, 99, 106, 94, 101 45.2  (3.18) 45.6  (3.08) 45.1  (2.86) 45.9  (3.00) 45.3  (2.96) 45.2  (3.01)
Albumin, W8, n= 78, 84, 90, 97, 86, 83 44.9  (3.12) 44.8  (3.30) 44.9  (2.97) 45.6  (2.91) 44.5  (3.22) 44.9  (2.62)
Total protein, BL, n=94, 97, 99, 106, 94, 101 73.2  (4.04) 74.0  (4.46) 73.1  (4.60) 74.1  (4.63) 73.4  (4.50) 73.2  (4.23)
Total protein, W8, n= 78, 84, 90, 97, 86, 83 71.9  (3.65) 72.6  (4.21) 72.6  (4.62) 73.4  (4.58) 72.0  (4.66) 72.5  (4.05)
16.Secondary Outcome
Title Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Chloride, BL, n=94, 97, 99, 106, 94, 101 104.4  (2.25) 104.7  (2.38) 104.5  (2.50) 104.4  (2.41) 104.8  (2.17) 104.4  (2.49)
Chloride, W8, n=78, 84, 90, 97, 86, 83 104.8  (2.24) 104.8  (2.36) 104.7  (2.55) 104.2  (2.15) 104.7  (2.11) 104.6  (2.67)
Calcium, BL, n=94, 96, 99, 105, 93, 101 2.4  (0.10) 2.4  (0.10) 2.3  (0.09) 2.4  (0.11) 2.4  (0.13) 2.3  (0.09)
Calcium, W8, n=78, 83, 90, 97, 85, 82 2.4  (0.10) 2.3  (0.10) 2.3  (0.10) 2.4  (0.10) 2.4  (0.11) 2.4  (0.09)
CO2/BI, BL, n=94, 96, 99, 105, 93, 101 23.2  (2.58) 22.8  (2.71) 23.0  (2.31) 23.4  (2.49) 23.5  (2.45) 23.5  (2.74)
CO2/BI, W8, n=78, 83, 90, 97, 86, 82 23.1  (2.57) 22.8  (2.62) 22.7  (2.61) 23.3  (2.55) 22.7  (2.42) 22.8  (2.60)
Cholesterol, BL, n=94, 97, 99, 106, 94, 101 4.9  (1.02) 5.0  (1.04) 5.2  (1.14) 5.0  (0.97) 5.0  (1.08) 5.0  (1.10)
Cholesterol, W8, n=78, 84, 90, 97, 86, 83 5.0  (1.24) 4.9  (1.05) 5.1  (1.05) 5.2  (1.16) 5.0  (1.03) 5.0  (1.07)
Glucose, BL, n=94, 97, 99, 106, 94, 101 5.2  (0.99) 5.5  (2.05) 5.2  (1.18) 5.1  (0.89) 5.1  (0.83) 5.3  (1.54)
Glucose, W8, n=78, 84, 90, 97, 86, 83 5.2  (1.07) 5.4  (1.96) 5.2  (1.20) 5.0  (0.88) 5.2  (1.21) 5.1  (1.18)
PI, BL, n=94, 97, 99, 106, 94, 101 1.2  (0.22) 1.1  (0.20) 1.2  (0.17) 1.2  (0.22) 1.2  (0.21) 1.2  (0.18)
PI, W8, n=78, 84, 90, 97, 86, 83 1.3  (0.21) 1.2  (0.17) 1.2  (0.18) 1.3  (0.20) 1.2  (0.21) 1.2  (0.20)
Potassium, BL, n=94, 96, 99, 105, 93, 101 4.1  (0.39) 4.2  (0.44) 4.1  (0.38) 4.2  (0.40) 4.2  (0.45) 4.2  (0.40)
Potassium, W8, n=78, 83, 90, 97, 85, 82 4.2  (0.34) 4.2  (0.41) 4.2  (0.32) 4.2  (0.38) 4.2  (0.38) 4.2  (0.36)
Sodium, BL, n=94, 97, 99, 106, 94, 101 140.8  (1.82) 140.5  (2.05) 140.6  (1.92) 140.8  (2.16) 141.1  (1.91) 140.8  (2.04)
Sodium, W8, n=78, 84, 90, 97, 86, 83 140.7  (2.09) 140.5  (2.01) 140.7  (2.02) 140.6  (1.63) 140.9  (2.36) 140.8  (1.97)
BUN, BL, n=94, 97, 99, 106, 94, 101 5.4  (1.75) 5.3  (1.66) 5.3  (1.92) 5.7  (1.94) 5.7  (2.09) 5.4  (1.72)
BUN, W8, n=78, 84, 90, 97, 86, 83 5.5  (1.68) 5.2  (1.97) 5.0  (1.30) 5.5  (1.44) 5.2  (1.54) 5.0  (1.43)
17.Secondary Outcome
Title Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8
Hide Description Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
DBIL, BL, n=94, 97, 99, 106, 94, 101 2.1  (1.26) 2.1  (1.29) 2.0  (1.04) 2.0  (1.13) 1.8  (1.17) 2.0  (1.04)
DBIL, W8, n=77, 84, 89, 97, 86, 83 2.0  (1.03) 2.0  (0.94) 1.9  (0.98) 1.9  (1.02) 1.7  (0.93) 1.9  (1.05)
TBIL, BL, n=94, 97, 99, 106, 94, 101 9.6  (6.10) 9.7  (6.08) 9.0  (4.39) 9.3  (4.35) 8.7  (4.11) 9.0  (3.93)
TBIL, W8, n=78, 84, 90, 97, 86, 83 10.3  (5.57) 9.1  (4.14) 8.7  (3.99) 9.1  (3.88) 8.5  (3.46) 9.4  (4.39)
Uric acid, BL, n=94, 97, 99, 105, 94, 101 337.8  (88.15) 327.2  (85.64) 325.6  (85.82) 334.1  (90.63) 326.6  (85.37) 324.5  (78.64)
Uric acid, W8, n=78, 84, 90, 96, 86, 83 353.6  (86.64) 327.5  (84.69) 321.9  (91.90) 340.9  (89.48) 316.5  (81.29) 325.4  (80.48)
Creatinine, BL, n=94, 97, 99, 106, 94, 101 83.2  (19.89) 79.8  (14.72) 77.7  (14.52) 81.9  (16.68) 78.3  (15.21) 79.3  (15.08)
Creatinine, W8, n=78, 84, 90, 97, 86, 83 84.5  (19.21) 79.7  (15.67) 79.0  (13.45) 81.7  (14.90) 77.7  (14.32) 80.4  (15.97)
18.Secondary Outcome
Title Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal
Hide Description Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).
Time Frame Baseline and Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Measure Type: Number
Unit of Measure: participants
UOB, 1+, BL, n=92, 94, 95, 106, 93, 96 2 1 3 4 3 2
UOB, 2+, BL, n=92, 94, 95, 106, 93, 96 3 1 2 0 1 1
UOB, 3+, BL, n=92, 94, 95, 106, 93, 96 2 0 0 2 2 2
UOB, 4+, BL, n=92, 94, 95, 106, 93, 96 0 0 0 1 0 0
UOB, Mod, BL, n=92, 94, 95, 106, 93, 96 1 0 0 0 0 1
UOB, Neg, BL, n=92, 94, 95, 106, 93, 96 79 91 83 97 81 82
UOB, Small, BL, n=92, 94, 95, 106, 93, 96 0 0 3 0 1 0
UOB, Trace, BL, n=92, 94, 95, 106, 93, 96 5 1 4 2 5 8
UOB, 1+, W8, n=71, 81, 82, 93, 82, 77 1 1 1 0 4 3
UOB, 2+, W8, n=71, 81, 82, 93, 82, 77 4 2 2 2 2 3
UOB, 3+, W8, n=71, 81, 82, 93, 82, 77 0 3 0 0 0 1
UOB, Large, W8, n=71, 81, 82, 93, 82, 77 0 0 0 0 1 0
UOB, Mod, W8, n=71, 81, 82, 93, 82, 77 0 0 0 0 1 0
UOB, Neg, W8, n=71, 81, 82, 93, 82, 77 62 71 73 83 69 66
UOB, Trace, W8, n=71, 81, 82, 93, 82, 77 4 4 6 8 5 4
UOB, Neg, EW, n=2, 1, 2, 3, 1, 7 2 1 2 3 1 7
UG, 1+ or 1/4 G/DL, BL, n=92, 94, 95, 106, 93, 96 0 0 0 0 0 1
UG, 3+ or 1 G/DL, BL, n=92, 94, 95, 106, 93, 96 0 2 1 0 0 1
UG, 4+ or 2 or more G/DL, n=92, 94, 95, 106, 93,96 0 1 0 0 0 0
UG, Neg, BL, n=92, 94, 95, 106, 93, 96 90 91 94 105 91 94
UG, Trace, BL, n=92, 94, 95, 106, 93, 96 1 0 0 1 1 0
UG, Trace or 1/10 G/DL, BL, n=92, 94, 95,106,93,96 1 0 0 0 1 0
UG, 1+ or 1/4 G/DL, W8, n=71, 81, 82, 93, 82, 77 0 1 1 0 0 0
UG, 3+ or 1 G/DL, W8, n=71, 81, 82, 93, 82, 77 0 3 1 0 0 1
UG, Neg, W8, n=71, 81, 82, 93, 82, 77 71 77 80 92 78 76
UG, Trace, W8, n=71, 81, 82, 93, 82, 77 0 0 0 0 2 0
UG, Trace or 1/10 G/DL, W8, n=71, 81, 82, 93,82,77 0 0 0 1 2 0
UG, Neg, EW, n=2, 1, 2, 3, 1, 7 2 1 2 3 1 7
UK, 1+, BL, n=92, 94, 95, 106, 93, 96 0 0 1 1 1 0
UK, 2+, BL, n=92, 94, 95, 106, 93, 96 0 0 0 0 1 0
UK, Neg, BL, n=92, 94, 95, 106, 93, 96 91 89 92 104 90 95
UK, Trace, BL, n=92, 94, 95, 106, 93, 96 1 5 2 1 1 1
UK, 2+, W8, n=71, 81, 82, 93, 82, 77 0 0 0 1 0 0
UK, Neg, W8, n=71, 81, 82, 93, 82, 77 67 77 78 91 79 69
UK, Trace, W8, n=71, 81, 82, 93, 82, 77 4 4 4 1 3 8
UK, Neg, EW, n=2, 1, 2, 3, 1, 7 2 1 2 3 1 7
UP, 1+, BL, n=92, 94, 95, 106, 93, 96 7 7 6 8 5 4
UP, 2+, BL, n=92, 94, 95, 106, 93, 96 0 0 2 1 1 0
UP, 3+, BL, n=92, 94, 95, 106, 93, 96 1 1 0 0 0 0
UP, Neg, BL, n=92, 94, 95, 106, 93, 96 70 76 80 89 80 78
UP, Trace, BL, n=92, 94, 95, 106, 93, 96 14 10 7 8 7 14
UP, 1+, W8, n=71, 81, 82, 93, 82, 77 3 2 5 1 4 2
UP, 2+, W8, n=71, 81, 82, 93, 82, 77 2 1 0 1 1 0
UP, 3+, W8, n=71, 81, 82, 93, 82, 77 0 0 0 0 1 0
UP, Neg, W8,n=71, 81, 82, 93, 82, 77 60 70 68 78 64 71
UP, Trace, W8, n=71, 81, 82, 93, 82, 77 6 8 9 13 12 4
UP, Neg, EW, n=2, 1, 2, 3, 1, 7, 1, 7 2 1 2 3 1 5
UP, Trace, EW, n=2, 1, 2, 3, 1, 7 0 0 0 0 0 2
UWBC, 1+, BL, n=92, 94, 95, 106, 93, 96 1 1 6 1 6 3
UWBC, 2+, BL, n=92, 94, 95, 106, 93, 96 1 3 1 7 2 3
UWBC, 3+, BL, n=92, 94, 95, 106, 93, 96 0 3 2 2 1 2
UWBC, Mod, BL, n=92, 94, 95, 106, 93, 96 0 0 0 0 1 0
UWBC, Neg, BL, n=92, 94, 95, 106, 93, 96 88 84 82 92 81 85
UWBC, Trace, BL, n=92, 94, 95, , 93, 96 2 3 4 4 2 3
UWBC, 1+, W8, n=71, 81, 82, 93, 82, 77 1 3 2 3 7 4
UWBC, 2+, W8, n=71, 81, 82, 93, 82, 77 1 1 4 3 2 3
UWBC, 3+, W8, n=71, 81, 82, 93, 82, 77 0 0 2 1 0 1
UWBC, Neg, W8, n=71, 81, 82, 93, 82, 77 66 71 69 81 67 67
UWBC, Small, W8, n=71, 81, 82, 93, 82, 77 1 0 1 0 0 0
UWBC, Trace, W8, n=71, 81, 82, 93, 82, 77 2 6 4 5 6 2
UWBC, 2+, EW, n=2, 1, 2, 3, 1, 7 0 1 0 0 0 1
UWBC, Neg, EW, n=2, 1, 2, 3, 1, 7 2 0 2 3 1 6
19.Secondary Outcome
Title Urine Specific Gravity at Baseline and Week 8/Early Withdrawal
Hide Description Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Time Frame Baseline and Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline, n=92, 94, 95, 106, 93, 96 1.0230  (0.00707) 1.0240  (0.00690) 1.0236  (0.00682) 1.0230  (0.00687) 1.0242  (0.00620) 1.0227  (0.00760)
Week 8, n=71, 81, 82, 93, 82, 77 1.0238  (0.00731) 1.0227  (0.00735) 1.0230  (0.00714) 1.0223  (0.00738) 1.0235  (0.00727) 1.0217  (0.00751)
EW, n=2, 1, 2, 3, 1, 7 1.0265  (0.00071) 1.0121  (0) 1.0200  (0.00141) 1.0233  (0.00987) 1.0190  (0) 1.0240  (0.00653)
20.Secondary Outcome
Title Urine pH at Baseline and Week 8/Early Withdrawal
Hide Description Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time Frame Baseline and Week 8/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 94 97 100 110 95 102
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline, n=92, 94, 95, 106, 93, 96 6.04  (0.487) 6.05  (0.418) 6.06  (0.455) 6.13  (0.488) 6.05  (0.489) 6.08  (0.415)
Week 8, n=71, 81, 82, 93, 82, 77 6.03  (0.422) 6.01  (0.418) 6.12  (0.462) 6.06  (0.435) 6.06  (0.523) 5.96  (0.342)
EW, n=2, 1, 2, 3, 1, 7 6.00  (0.707) 6.00  (0) 5.75  (0.354) 6.83  (0.289) 7.50  (0) 5.86  (0.556)
21.Secondary Outcome
Title 24-hour Urinary Cortisol Excretion at Baseline and Week 8
Hide Description A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr urinary cortisol was taken from Visit 3.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 66 72 72 76 69 70
Median (Full Range)
Unit of Measure: Nanomoles per 24 hours (nmol/24 hours)
Baseline
70.20
(10.1 to 382.7)
74.45
(6.1 to 645.2)
65.80
(5.9 to 341.1)
65.56
(8.8 to 457.3)
66.80
(4.6 to 396.2)
66.20
(6.4 to 338.6)
Week 8
79.25
(7.5 to 275.0)
76.74
(5.2 to 306.6)
79.15
(13.9 to 680.9)
81.0
(10.6 to 506.6)
62.10
(8.0 to 366.7)
82.14
(4.7 to 231.0)
22.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8
Hide Description Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 78 85 91 98 86 84
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP -2.5  (9.29) 1.5  (10.54) 0.9  (10.35) -0.4  (10.46) 1.4  (9.53) 0.2  (10.64)
DBP -1.1  (8.16) 0.3  (7.65) 0.2  (7.50) -0.3  (8.41) 0.1  (8.50) -0.2  (8.55)
23.Secondary Outcome
Title Change From Baseline in Heart Rate at Week 8
Hide Description Change from Baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description:
Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Overall Number of Participants Analyzed 78 85 91 98 86 84
Mean (Standard Deviation)
Unit of Measure: Beats per minute
2.9  (9.23) 0.4  (8.26) 1.5  (8.35) 0.8  (8.12) -2.3  (8.32) 0.8  (9.14)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the the treatment period (up to Week 8).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
 
Arm/Group Title Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Hide Arm/Group Description Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study. Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study. Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
All-Cause Mortality
Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   1/97 (1.03%)   0/100 (0.00%)   1/110 (0.91%)   0/95 (0.00%)   2/102 (1.96%) 
Gastrointestinal disorders             
Gastritis  1  0/94 (0.00%)  0/97 (0.00%)  0/100 (0.00%)  0/110 (0.00%)  0/95 (0.00%)  1/102 (0.98%) 
General disorders             
Chest pain  1  0/94 (0.00%)  0/97 (0.00%)  0/100 (0.00%)  0/110 (0.00%)  0/95 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications             
Snake bite  1  0/94 (0.00%)  1/97 (1.03%)  0/100 (0.00%)  0/110 (0.00%)  0/95 (0.00%)  0/102 (0.00%) 
Psychiatric disorders             
Depression  1  0/94 (0.00%)  0/97 (0.00%)  0/100 (0.00%)  1/110 (0.91%)  0/95 (0.00%)  0/102 (0.00%) 
Skin and subcutaneous tissue disorders             
Hyperhidrosis  1  0/94 (0.00%)  0/97 (0.00%)  0/100 (0.00%)  0/110 (0.00%)  0/95 (0.00%)  1/102 (0.98%) 
Vascular disorders             
Hypertension  1  0/94 (0.00%)  0/97 (0.00%)  0/100 (0.00%)  0/110 (0.00%)  0/95 (0.00%)  1/102 (0.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo GW685698X 25 µg OD GW685698X 50 µg OD GW685698X 100 µg OD GW685698X 200 µg OD FP 100 µg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/94 (11.70%)   6/97 (6.19%)   8/100 (8.00%)   17/110 (15.45%)   9/95 (9.47%)   16/102 (15.69%) 
Infections and infestations             
Nasopharyngitis  1  1/94 (1.06%)  0/97 (0.00%)  0/100 (0.00%)  4/110 (3.64%)  3/95 (3.16%)  2/102 (1.96%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/94 (0.00%)  0/97 (0.00%)  3/100 (3.00%)  0/110 (0.00%)  1/95 (1.05%)  1/102 (0.98%) 
Nervous system disorders             
Headache  1  10/94 (10.64%)  6/97 (6.19%)  6/100 (6.00%)  12/110 (10.91%)  5/95 (5.26%)  12/102 (11.76%) 
Respiratory, thoracic and mediastinal disorders             
Oropharyngitis  1  1/94 (1.06%)  0/97 (0.00%)  1/100 (1.00%)  4/110 (3.64%)  3/95 (3.16%)  2/102 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00603382     History of Changes
Other Study ID Numbers: FFA109687
First Submitted: December 27, 2007
First Posted: January 29, 2008
Results First Submitted: June 6, 2013
Results First Posted: August 19, 2013
Last Update Posted: April 18, 2018