Trial Outcomes & Findings for A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy. (NCT NCT00603746)

Last Updated: 2017-09-15

Results Overview

Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly 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 (BL) through Week 8 clinic visits. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

627 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2017-09-15

Participant Flow

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. 1175 par. were screened, and 627 par. were randomized, out of which 622 par. received at least one dose of study treatment.

Participant milestones

Participant milestones
Measure	Placebo 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
Overall Study STARTED	103	99	101	107	102	110
Overall Study COMPLETED	65	81	93	94	85	97
Overall Study NOT COMPLETED	38	18	8	13	17	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
Overall Study Adverse Event	2	3	0	1	0	4
Overall Study Lack of Efficacy	34	11	6	11	12	8
Overall Study Protocol Violation	0	3	1	0	1	0
Overall Study Lost to Follow-up	0	1	1	0	0	0
Overall Study Physician Decision	1	0	0	0	1	0
Overall Study Withdrawal by Subject	1	0	0	1	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	Total n=622 Participants Total of all reporting groups
Age, Continuous	47.2 Years STANDARD_DEVIATION 14.03 • n=5 Participants	45.7 Years STANDARD_DEVIATION 15.02 • n=7 Participants	47.2 Years STANDARD_DEVIATION 14.39 • n=5 Participants	45.7 Years STANDARD_DEVIATION 14.38 • n=4 Participants	46.6 Years STANDARD_DEVIATION 14.09 • n=21 Participants	46.1 Years STANDARD_DEVIATION 13.86 • n=8 Participants	46.4 Years STANDARD_DEVIATION 14.25 • n=8 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	63 Participants n=7 Participants	62 Participants n=5 Participants	67 Participants n=4 Participants	63 Participants n=21 Participants	68 Participants n=8 Participants	387 Participants n=8 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	40 Participants n=4 Participants	39 Participants n=21 Participants	42 Participants n=8 Participants	235 Participants n=8 Participants
Race/Ethnicity, Customized African American/African Heritage (HER)	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	4 participants n=8 Participants	20 participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	6 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	8 participants n=4 Participants	5 participants n=21 Participants	7 participants n=8 Participants	38 participants n=8 Participants
Race/Ethnicity, Customized Central/South Asian HER	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	12 participants n=8 Participants
Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER	4 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	35 participants n=8 Participants
Race/Ethnicity, Customized White	83 participants n=5 Participants	74 participants n=7 Participants	80 participants n=5 Participants	77 participants n=4 Participants	80 participants n=21 Participants	83 participants n=8 Participants	477 participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native & Asian & White	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native & White	6 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	7 participants n=4 Participants	6 participants n=21 Participants	8 participants n=8 Participants	38 participants n=8 Participants
Race/Ethnicity, Customized Missing	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	1 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8	-0.043 Liters Standard Error 0.0338	0.232 Liters Standard Error 0.0347	0.229 Liters Standard Error 0.0342	0.221 Liters Standard Error 0.0332	0.182 Liters Standard Error 0.0342	0.155 Liters Standard Error 0.0332

SECONDARY outcome

Timeframe: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. 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.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=101 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=109 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
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	-5.1 Liters per minute Standard Error 3.32	11.9 Liters per minute Standard Error 3.32	14.5 Liters per minute Standard Error 3.29	11.7 Liters per minute Standard Error 3.20	16.3 Liters per minute Standard Error 3.30	11.1 Liters per minute Standard Error 3.17

SECONDARY outcome

Timeframe: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. 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.

Outcome measures

Outcome measures
Measure	Placebo n=101 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=101 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=109 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period	-7.3 Liters per minute Standard Error 3.32	19.6 Liters per minute Standard Error 3.34	20.9 Liters per minute Standard Error 3.31	16.7 Liters per minute Standard Error 3.22	20.7 Liters per minute Standard Error 3.32	16.5 Liters per minute Standard Error 3.19

SECONDARY outcome

Timeframe: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Placebo n=101 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=101 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period	6.4 Percentage of symptom-free 24-hr periods Standard Error 2.71	20.1 Percentage of symptom-free 24-hr periods Standard Error 2.74	19.6 Percentage of symptom-free 24-hr periods Standard Error 2.71	15.1 Percentage of symptom-free 24-hr periods Standard Error 2.63	18.5 Percentage of symptom-free 24-hr periods Standard Error 2.71	15.4 Percentage of symptom-free 24-hr periods Standard Error 2.61

SECONDARY outcome

Timeframe: From Baseline up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Placebo n=101 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=101 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period	3.6 Percentage of rescue-free 24-hr periods Standard Error 2.75	17.9 Percentage of rescue-free 24-hr periods Standard Error 2.78	21.1 Percentage of rescue-free 24-hr periods Standard Error 2.75	17.4 Percentage of rescue-free 24-hr periods Standard Error 2.67	22.3 Percentage of rescue-free 24-hr periods Standard Error 2.75	16.7 Percentage of rescue-free 24-hr periods Standard Error 2.63

SECONDARY outcome

Timeframe: From the first dose of the study medication up to Week 8/Early Withdrawal

Population: ITT Population

The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period	34 participants	11 participants	6 participants	11 participants	12 participants	8 participants

SECONDARY outcome

Timeframe: From the first dose of the study medication up to Week 8/Early Withdrawal

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period Any AE	23 participants	31 participants	34 participants	37 participants	36 participants	39 participants
Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period Any SAE	1 participants	2 participants	0 participants	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 8/Early Withdrawal

Population: ITT Population

A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis Clinical evidence	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis No clinical evidence	103 participants	99 participants	101 participants	107 participants	102 participants	110 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Eosinophils, W 8, n=64, 78, 86, 88, 80, 93	3.92 Percentage in the blood Standard Deviation 2.835	3.54 Percentage in the blood Standard Deviation 2.784	2.76 Percentage in the blood Standard Deviation 1.943	2.94 Percentage in the blood Standard Deviation 3.395	2.14 Percentage in the blood Standard Deviation 2.076	3.31 Percentage in the blood Standard Deviation 2.815
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Total neutrophils, W 8, n=64, 78, 86, 88, 80, 93	59.78 Percentage in the blood Standard Deviation 9.101	60.95 Percentage in the blood Standard Deviation 7.819	61.87 Percentage in the blood Standard Deviation 9.175	64.67 Percentage in the blood Standard Deviation 10.031	63.41 Percentage in the blood Standard Deviation 10.926	62.19 Percentage in the blood Standard Deviation 9.128
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Basophils, BL, n=96, 98, 96, 101, 96, 104	0.31 Percentage in the blood Standard Deviation 0.211	0.38 Percentage in the blood Standard Deviation 0.315	0.35 Percentage in the blood Standard Deviation 0.252	0.34 Percentage in the blood Standard Deviation 0.306	0.36 Percentage in the blood Standard Deviation 0.220	0.34 Percentage in the blood Standard Deviation 0.181
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Basophils, W 8, n=64, 78, 86, 88, 80, 93	0.38 Percentage in the blood Standard Deviation 0.191	0.35 Percentage in the blood Standard Deviation 0.199	0.28 Percentage in the blood Standard Deviation 0.172	0.26 Percentage in the blood Standard Deviation 0.164	0.31 Percentage in the blood Standard Deviation 0.175	0.30 Percentage in the blood Standard Deviation 0.159
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Eosinophils, BL, n=96, 98, 96, 101, 96, 104	4.21 Percentage in the blood Standard Deviation 3.241	4.11 Percentage in the blood Standard Deviation 3.024	3.70 Percentage in the blood Standard Deviation 2.942	4.34 Percentage in the blood Standard Deviation 3.148	3.74 Percentage in the blood Standard Deviation 2.543	3.50 Percentage in the blood Standard Deviation 2.675
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Lymphocytes, BL, n=96, 98, 96, 101, 96, 104	32.23 Percentage in the blood Standard Deviation 7.231	32.31 Percentage in the blood Standard Deviation 8.344	33.48 Percentage in the blood Standard Deviation 9.299	32.03 Percentage in the blood Standard Deviation 7.813	33.33 Percentage in the blood Standard Deviation 7.990	30.13 Percentage in the blood Standard Deviation 8.938
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Lymphocytes, W 8, n=64, 78, 86, 88, 80, 93	30.87 Percentage in the blood Standard Deviation 8.332	30.64 Percentage in the blood Standard Deviation 7.046	30.28 Percentage in the blood Standard Deviation 8.734	27.64 Percentage in the blood Standard Deviation 9.216	29.50 Percentage in the blood Standard Deviation 9.763	29.23 Percentage in the blood Standard Deviation 8.205
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Monocytes, BL, n=96, 98, 96, 101, 96, 104	5.03 Percentage in the blood Standard Deviation 2.337	4.75 Percentage in the blood Standard Deviation 1.765	5.23 Percentage in the blood Standard Deviation 2.580	4.89 Percentage in the blood Standard Deviation 1.896	5.19 Percentage in the blood Standard Deviation 2.384	5.06 Percentage in the blood Standard Deviation 1.989
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Monocytes, W 8, n=64, 78, 86, 88, 80, 93	5.07 Percentage in the blood Standard Deviation 1.885	4.53 Percentage in the blood Standard Deviation 2.025	4.82 Percentage in the blood Standard Deviation 2.087	4.50 Percentage in the blood Standard Deviation 2.188	4.64 Percentage in the blood Standard Deviation 2.224	4.97 Percentage in the blood Standard Deviation 2.150
Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 Total neutrophils, BL, n=96, 98, 96, 101, 96, 104	58.22 Percentage in the blood Standard Deviation 8.020	58.45 Percentage in the blood Standard Deviation 9.166	57.08 Percentage in the blood Standard Deviation 10.168	58.41 Percentage in the blood Standard Deviation 8.589	57.33 Percentage in the blood Standard Deviation 8.627	60.96 Percentage in the blood Standard Deviation 10.096

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Hematocrit at Baseline and Week 8 Baseline, n=95, 98, 96, 100, 94, 104	0.43 Proportion of 1 Standard Deviation 0.039	0.43 Proportion of 1 Standard Deviation 0.034	0.42 Proportion of 1 Standard Deviation 0.035	0.42 Proportion of 1 Standard Deviation 0.042	0.43 Proportion of 1 Standard Deviation 0.038	0.42 Proportion of 1 Standard Deviation 0.043
Hematocrit at Baseline and Week 8 Week 8, n=64, 78, 86, 89, 80, 93	0.43 Proportion of 1 Standard Deviation 0.040	0.42 Proportion of 1 Standard Deviation 0.036	0.42 Proportion of 1 Standard Deviation 0.035	0.42 Proportion of 1 Standard Deviation 0.042	0.43 Proportion of 1 Standard Deviation 0.037	0.42 Proportion of 1 Standard Deviation 0.043

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Hemoglobin at Baseline and Week 8 Baseline, n=95, 98, 96, 100, 94, 104	139.99 Grams per liter (G/L) Standard Deviation 13.230	140.20 Grams per liter (G/L) Standard Deviation 11.183	139.35 Grams per liter (G/L) Standard Deviation 11.577	138.50 Grams per liter (G/L) Standard Deviation 14.987	140.91 Grams per liter (G/L) Standard Deviation 13.023	138.53 Grams per liter (G/L) Standard Deviation 14.770
Hemoglobin at Baseline and Week 8 Week 8, n=64, 78, 86, 89, 80, 93	139.63 Grams per liter (G/L) Standard Deviation 12.359	137.42 Grams per liter (G/L) Standard Deviation 11.461	137.56 Grams per liter (G/L) Standard Deviation 11.747	135.81 Grams per liter (G/L) Standard Deviation 13.847	140.64 Grams per liter (G/L) Standard Deviation 12.679	137.31 Grams per liter (G/L) Standard Deviation 14.650

SECONDARY outcome

Timeframe: Baseline and Week 8

Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Platelet Count and White Blood Cell Count at Baseline and Week 8 WBC count, W8, n=64, 78, 86, 88, 80, 93	7.84 10^9 cells per liter (GI/L) Standard Deviation 1.944	7.97 10^9 cells per liter (GI/L) Standard Deviation 1.671	8.38 10^9 cells per liter (GI/L) Standard Deviation 2.416	9.10 10^9 cells per liter (GI/L) Standard Deviation 2.134	8.90 10^9 cells per liter (GI/L) Standard Deviation 1.964	8.21 10^9 cells per liter (GI/L) Standard Deviation 1.973
Platelet Count and White Blood Cell Count at Baseline and Week 8 Platelet count, BL, n=95, 98, 96, 99, 94, 104	275.76 10^9 cells per liter (GI/L) Standard Deviation 58.949	281.46 10^9 cells per liter (GI/L) Standard Deviation 74.550	270.32 10^9 cells per liter (GI/L) Standard Deviation 50.756	275.62 10^9 cells per liter (GI/L) Standard Deviation 56.811	269.09 10^9 cells per liter (GI/L) Standard Deviation 61.890	269.80 10^9 cells per liter (GI/L) Standard Deviation 65.376
Platelet Count and White Blood Cell Count at Baseline and Week 8 Platelet count, W8, n=64, 78, 86, 89, 79, 93	265.86 10^9 cells per liter (GI/L) Standard Deviation 55.155	285.62 10^9 cells per liter (GI/L) Standard Deviation 66.487	270.77 10^9 cells per liter (GI/L) Standard Deviation 50.491	291.36 10^9 cells per liter (GI/L) Standard Deviation 63.650	280.78 10^9 cells per liter (GI/L) Standard Deviation 65.044	275.48 10^9 cells per liter (GI/L) Standard Deviation 65.011
Platelet Count and White Blood Cell Count at Baseline and Week 8 WBC count, BL, n=95, 98, 96, 99, 94, 104	8.16 10^9 cells per liter (GI/L) Standard Deviation 2.182	7.77 10^9 cells per liter (GI/L) Standard Deviation 2.016	8.01 10^9 cells per liter (GI/L) Standard Deviation 2.199	8.18 10^9 cells per liter (GI/L) Standard Deviation 1.807	7.91 10^9 cells per liter (GI/L) Standard Deviation 1.853	8.25 10^9 cells per liter (GI/L) Standard Deviation 2.400

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Red Blood Cell Count at Baseline and Week 8 Baseline, n=95, 98, 96, 100, 94, 104	4.67 10^12 cells per liter (TI/L) Standard Deviation 0.413	4.69 10^12 cells per liter (TI/L) Standard Deviation 0.438	4.64 10^12 cells per liter (TI/L) Standard Deviation 0.413	4.60 10^12 cells per liter (TI/L) Standard Deviation 0.428	4.66 10^12 cells per liter (TI/L) Standard Deviation 0.416	4.64 10^12 cells per liter (TI/L) Standard Deviation 0.421
Red Blood Cell Count at Baseline and Week 8 Week 8, n=64, 78, 86, 89, 80, 93	4.61 10^12 cells per liter (TI/L) Standard Deviation 0.423	4.64 10^12 cells per liter (TI/L) Standard Deviation 0.472	4.57 10^12 cells per liter (TI/L) Standard Deviation 0.383	4.52 10^12 cells per liter (TI/L) Standard Deviation 0.442	4.65 10^12 cells per liter (TI/L) Standard Deviation 0.425	4.61 10^12 cells per liter (TI/L) Standard Deviation 0.430

SECONDARY outcome

Timeframe: Baseline and Week 8

Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 ALT, BL, n=101, 97, 101, 107, 101, 109	22.4 International units per liter (IU/L) Standard Deviation 12.52	21.0 International units per liter (IU/L) Standard Deviation 10.02	23.9 International units per liter (IU/L) Standard Deviation 15.07	23.5 International units per liter (IU/L) Standard Deviation 18.89	23.1 International units per liter (IU/L) Standard Deviation 14.71	20.5 International units per liter (IU/L) Standard Deviation 13.26
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 ALT, W8, n=66, 79, 91, 90, 86, 96	23.7 International units per liter (IU/L) Standard Deviation 19.99	20.2 International units per liter (IU/L) Standard Deviation 11.31	21.6 International units per liter (IU/L) Standard Deviation 14.43	20.4 International units per liter (IU/L) Standard Deviation 12.33	22.0 International units per liter (IU/L) Standard Deviation 12.14	20.7 International units per liter (IU/L) Standard Deviation 14.56
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 ALP, BL, n=101, 97, 101, 107, 100, 109	74.7 International units per liter (IU/L) Standard Deviation 21.34	80.2 International units per liter (IU/L) Standard Deviation 41.24	90.9 International units per liter (IU/L) Standard Deviation 54.98	77.1 International units per liter (IU/L) Standard Deviation 38.35	73.9 International units per liter (IU/L) Standard Deviation 31.02	76.7 International units per liter (IU/L) Standard Deviation 32.97
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 ALP, W8, n=66, 78, 91, 89, 86, 96	75.1 International units per liter (IU/L) Standard Deviation 21.38	80.4 International units per liter (IU/L) Standard Deviation 54.47	86.6 International units per liter (IU/L) Standard Deviation 42.66	74.5 International units per liter (IU/L) Standard Deviation 26.54	70.6 International units per liter (IU/L) Standard Deviation 26.33	77.2 International units per liter (IU/L) Standard Deviation 28.25
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 AST, BL, n=101, 97, 100, 106, 101, 108	21.6 International units per liter (IU/L) Standard Deviation 6.45	21.6 International units per liter (IU/L) Standard Deviation 7.11	23.7 International units per liter (IU/L) Standard Deviation 10.46	23.3 International units per liter (IU/L) Standard Deviation 20.15	22.7 International units per liter (IU/L) Standard Deviation 8.42	21.9 International units per liter (IU/L) Standard Deviation 11.34
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 AST, W8, n=66, 78, 91, 89, 85, 96	24.1 International units per liter (IU/L) Standard Deviation 20.87	21.6 International units per liter (IU/L) Standard Deviation 8.39	22.0 International units per liter (IU/L) Standard Deviation 11.41	22.1 International units per liter (IU/L) Standard Deviation 17.12	22.0 International units per liter (IU/L) Standard Deviation 9.25	21.4 International units per liter (IU/L) Standard Deviation 8.61
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 GGT, BL, n=101, 97, 101, 107, 101, 109	33.0 International units per liter (IU/L) Standard Deviation 26.34	36.8 International units per liter (IU/L) Standard Deviation 39.79	40.4 International units per liter (IU/L) Standard Deviation 44.86	42.3 International units per liter (IU/L) Standard Deviation 109.34	31.2 International units per liter (IU/L) Standard Deviation 22.88	28.2 International units per liter (IU/L) Standard Deviation 20.50
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 GGT, W8, n=66, 79, 91, 90, 86, 96	36.4 International units per liter (IU/L) Standard Deviation 37.07	32.7 International units per liter (IU/L) Standard Deviation 22.50	40.6 International units per liter (IU/L) Standard Deviation 70.55	47.4 International units per liter (IU/L) Standard Deviation 167.46	34.1 International units per liter (IU/L) Standard Deviation 28.31	29.2 International units per liter (IU/L) Standard Deviation 20.01
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 LDH, BL, n=101, 97, 100, 106, 101, 108	158.2 International units per liter (IU/L) Standard Deviation 26.10	162.0 International units per liter (IU/L) Standard Deviation 27.64	163.5 International units per liter (IU/L) Standard Deviation 35.16	158.7 International units per liter (IU/L) Standard Deviation 30.24	161.6 International units per liter (IU/L) Standard Deviation 31.49	160.6 International units per liter (IU/L) Standard Deviation 24.97
Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8 LDH, W8, n=66, 78, 91, 89, 85, 96	160.4 International units per liter (IU/L) Standard Deviation 43.44	159.0 International units per liter (IU/L) Standard Deviation 27.52	163.6 International units per liter (IU/L) Standard Deviation 37.00	164.6 International units per liter (IU/L) Standard Deviation 35.80	170.6 International units per liter (IU/L) Standard Deviation 33.92	164.0 International units per liter (IU/L) Standard Deviation 27.59

SECONDARY outcome

Timeframe: Baseline and Week 8

Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 Albumin, BL, n=101, 97, 101, 107, 101, 109	44.6 Grams per liter (g/L) Standard Deviation 2.36	44.9 Grams per liter (g/L) Standard Deviation 3.11	45.1 Grams per liter (g/L) Standard Deviation 2.91	44.3 Grams per liter (g/L) Standard Deviation 3.27	44.8 Grams per liter (g/L) Standard Deviation 3.49	44.9 Grams per liter (g/L) Standard Deviation 2.96
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 Albumin, W8, n=66, 79, 91, 90, 86, 96	44.5 Grams per liter (g/L) Standard Deviation 2.66	44.8 Grams per liter (g/L) Standard Deviation 3.27	44.6 Grams per liter (g/L) Standard Deviation 3.32	44.0 Grams per liter (g/L) Standard Deviation 3.28	44.1 Grams per liter (g/L) Standard Deviation 3.38	44.6 Grams per liter (g/L) Standard Deviation 3.07
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 Total protein, BL, n=101, 97, 101, 107, 101, 109	72.7 Grams per liter (g/L) Standard Deviation 3.82	73.4 Grams per liter (g/L) Standard Deviation 3.90	73.2 Grams per liter (g/L) Standard Deviation 4.15	73.3 Grams per liter (g/L) Standard Deviation 4.22	73.1 Grams per liter (g/L) Standard Deviation 4.80	72.5 Grams per liter (g/L) Standard Deviation 3.85
Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 Total protein, W8, n=66, 79, 91, 90, 86, 96	72.0 Grams per liter (g/L) Standard Deviation 4.21	72.6 Grams per liter (g/L) Standard Deviation 3.67	72.7 Grams per liter (g/L) Standard Deviation 4.54	72.2 Grams per liter (g/L) Standard Deviation 4.20	72.0 Grams per liter (g/L) Standard Deviation 4.39	71.9 Grams per liter (g/L) Standard Deviation 4.34

SECONDARY outcome

Timeframe: Baseline and Week 8

Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Potassium, W8, n=66, 78, 91, 89, 85, 96	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.36	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.60	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.41	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.38	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.32	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.36
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Calcium, BL, n=101, 97, 100, 106, 101, 108	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.07	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.10	2.4 Millimoles per liter (mmol/L) Standard Deviation 0.09	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.09	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.09	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.09
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Calcium, W8, n=66, 78, 91, 89, 85, 96	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.09	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.11	2.4 Millimoles per liter (mmol/L) Standard Deviation 0.10	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.11	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.10	2.3 Millimoles per liter (mmol/L) Standard Deviation 0.09
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 CO2/BI, BL, n=101, 97, 100, 106, 101, 108	23.2 Millimoles per liter (mmol/L) Standard Deviation 2.45	22.9 Millimoles per liter (mmol/L) Standard Deviation 2.75	23.3 Millimoles per liter (mmol/L) Standard Deviation 2.39	22.6 Millimoles per liter (mmol/L) Standard Deviation 2.87	23.1 Millimoles per liter (mmol/L) Standard Deviation 2.56	23.2 Millimoles per liter (mmol/L) Standard Deviation 2.33
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 CO2/BI, W8, n=66, 78, 91, 89, 85, 96	22.7 Millimoles per liter (mmol/L) Standard Deviation 3.01	22.7 Millimoles per liter (mmol/L) Standard Deviation 2.68	23.5 Millimoles per liter (mmol/L) Standard Deviation 2.71	22.6 Millimoles per liter (mmol/L) Standard Deviation 2.56	23.3 Millimoles per liter (mmol/L) Standard Deviation 2.11	22.9 Millimoles per liter (mmol/L) Standard Deviation 2.73
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Chloride, BL, n=101, 97, 101, 107, 101, 109	104.8 Millimoles per liter (mmol/L) Standard Deviation 2.45	104.4 Millimoles per liter (mmol/L) Standard Deviation 2.24	104.1 Millimoles per liter (mmol/L) Standard Deviation 2.84	104.3 Millimoles per liter (mmol/L) Standard Deviation 2.24	104.4 Millimoles per liter (mmol/L) Standard Deviation 2.25	105.0 Millimoles per liter (mmol/L) Standard Deviation 2.80
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Chloride, W8, n=66, 79, 91, 90, 86, 96	105.0 Millimoles per liter (mmol/L) Standard Deviation 2.52	104.4 Millimoles per liter (mmol/L) Standard Deviation 2.46	103.9 Millimoles per liter (mmol/L) Standard Deviation 2.84	104.3 Millimoles per liter (mmol/L) Standard Deviation 2.46	104.1 Millimoles per liter (mmol/L) Standard Deviation 2.68	104.9 Millimoles per liter (mmol/L) Standard Deviation 2.79
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Cholesterol, BL, n=101, 97, 101, 107, 101, 109	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.04	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.11	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.13	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.21	5.5 Millimoles per liter (mmol/L) Standard Deviation 1.15	5.1 Millimoles per liter (mmol/L) Standard Deviation 1.08
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Cholesterol, W8, n=66, 79, 91, 90, 86, 96	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.00	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.09	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.07	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.24	5.5 Millimoles per liter (mmol/L) Standard Deviation 1.03	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.17
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Glucose, BL, n=101, 97, 101, 107	5.3 Millimoles per liter (mmol/L) Standard Deviation 0.81	5.5 Millimoles per liter (mmol/L) Standard Deviation 2.36	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.27	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.14	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.73	5.3 Millimoles per liter (mmol/L) Standard Deviation 0.91
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Glucose, W8, n=66, 78, 91, 90, 86, 96	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.38	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.81	5.5 Millimoles per liter (mmol/L) Standard Deviation 3.24	5.2 Millimoles per liter (mmol/L) Standard Deviation 1.19	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.91	5.3 Millimoles per liter (mmol/L) Standard Deviation 1.16
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 PI, BL, n=101, 97, 101, 107, 101, 109	1.1 Millimoles per liter (mmol/L) Standard Deviation 0.18	1.1 Millimoles per liter (mmol/L) Standard Deviation 0.18	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.22	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.19	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.19	1.1 Millimoles per liter (mmol/L) Standard Deviation 0.18
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 PI, W8, n=66, 79, 91, 90, 86, 96	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.16	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.17	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.15	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.16	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.17	1.2 Millimoles per liter (mmol/L) Standard Deviation 0.16
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Potassium, BL, n=101, 97, 100, 106, 101, 108	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.38	4.3 Millimoles per liter (mmol/L) Standard Deviation 0.47	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.51	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.41	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.30	4.2 Millimoles per liter (mmol/L) Standard Deviation 0.41
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Sodium, BL, n=101, 97, 101, 107, 101, 109	140.8 Millimoles per liter (mmol/L) Standard Deviation 1.93	140.4 Millimoles per liter (mmol/L) Standard Deviation 1.92	140.4 Millimoles per liter (mmol/L) Standard Deviation 2.06	140.1 Millimoles per liter (mmol/L) Standard Deviation 1.93	140.1 Millimoles per liter (mmol/L) Standard Deviation 1.64	140.8 Millimoles per liter (mmol/L) Standard Deviation 1.95
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Sodium, W8, n=66, 79, 91, 90, 86, 96	140.5 Millimoles per liter (mmol/L) Standard Deviation 2.15	140.3 Millimoles per liter (mmol/L) Standard Deviation 2.17	140.3 Millimoles per liter (mmol/L) Standard Deviation 2.09	140.1 Millimoles per liter (mmol/L) Standard Deviation 1.99	140.4 Millimoles per liter (mmol/L) Standard Deviation 2.21	140.6 Millimoles per liter (mmol/L) Standard Deviation 2.08
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Urea, BL, n=101, 97, 101, 107, 101, 109	5.7 Millimoles per liter (mmol/L) Standard Deviation 1.68	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.49	5.8 Millimoles per liter (mmol/L) Standard Deviation 1.72	5.0 Millimoles per liter (mmol/L) Standard Deviation 1.34	5.5 Millimoles per liter (mmol/L) Standard Deviation 1.52	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.63
Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8 Urea, W8, n=66, 79, 91, 90, 86, 96	5.5 Millimoles per liter (mmol/L) Standard Deviation 1.57	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.50	5.7 Millimoles per liter (mmol/L) Standard Deviation 1.37	5.4 Millimoles per liter (mmol/L) Standard Deviation 1.45	5.6 Millimoles per liter (mmol/L) Standard Deviation 1.35	5.6 Millimoles per liter (mmol/L) Standard Deviation 1.55

SECONDARY outcome

Timeframe: Baseline and Week 8

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).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 Creatinine, BL, n=101, 97, 101, 107, 101, 109	84.4 Micromoles per liter (µmol/L) Standard Deviation 14.89	79.8 Micromoles per liter (µmol/L) Standard Deviation 14.17	79.4 Micromoles per liter (µmol/L) Standard Deviation 15.86	78.8 Micromoles per liter (µmol/L) Standard Deviation 14.12	81.4 Micromoles per liter (µmol/L) Standard Deviation 13.90	82.0 Micromoles per liter (µmol/L) Standard Deviation 18.12
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 TBIL, W8, n=66, 79, 91, 90, 86, 96	8.3 Micromoles per liter (µmol/L) Standard Deviation 3.68	9.0 Micromoles per liter (µmol/L) Standard Deviation 4.44	9.8 Micromoles per liter (µmol/L) Standard Deviation 5.10	9.4 Micromoles per liter (µmol/L) Standard Deviation 5.65	8.6 Micromoles per liter (µmol/L) Standard Deviation 3.33	9.6 Micromoles per liter (µmol/L) Standard Deviation 4.76
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 Creatinine, W8, n=66, 79, 91, 90, 86, 96	83.2 Micromoles per liter (µmol/L) Standard Deviation 15.84	79.9 Micromoles per liter (µmol/L) Standard Deviation 12.40	78.6 Micromoles per liter (µmol/L) Standard Deviation 15.25	78.7 Micromoles per liter (µmol/L) Standard Deviation 13.95	81.7 Micromoles per liter (µmol/L) Standard Deviation 13.87	81.3 Micromoles per liter (µmol/L) Standard Deviation 18.02
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 DBIL, BL, n=101, 97, 101, 107, 101, 109	2.0 Micromoles per liter (µmol/L) Standard Deviation 0.92	2.0 Micromoles per liter (µmol/L) Standard Deviation 1.08	2.1 Micromoles per liter (µmol/L) Standard Deviation 1.15	2.0 Micromoles per liter (µmol/L) Standard Deviation 1.05	1.7 Micromoles per liter (µmol/L) Standard Deviation 0.94	2.1 Micromoles per liter (µmol/L) Standard Deviation 1.38
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 DBIL, W8, n=65, 78, 91, 90, 86, 96	1.7 Micromoles per liter (µmol/L) Standard Deviation 0.75	1.8 Micromoles per liter (µmol/L) Standard Deviation 0.91	2.1 Micromoles per liter (µmol/L) Standard Deviation 1.19	1.9 Micromoles per liter (µmol/L) Standard Deviation 1.22	1.7 Micromoles per liter (µmol/L) Standard Deviation 0.82	2.0 Micromoles per liter (µmol/L) Standard Deviation 1.20
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 TBIL, BL, n=101, 97, 101, 107, 101, 109	9.4 Micromoles per liter (µmol/L) Standard Deviation 4.67	9.9 Micromoles per liter (µmol/L) Standard Deviation 4.87	9.8 Micromoles per liter (µmol/L) Standard Deviation 5.19	9.7 Micromoles per liter (µmol/L) Standard Deviation 5.00	8.2 Micromoles per liter (µmol/L) Standard Deviation 3.31	10.3 Micromoles per liter (µmol/L) Standard Deviation 5.86
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 Uric acid, BL, n=101, 97, 101, 107, 101, 109	323.3 Micromoles per liter (µmol/L) Standard Deviation 102.51	326.1 Micromoles per liter (µmol/L) Standard Deviation 75.18	330.4 Micromoles per liter (µmol/L) Standard Deviation 81.69	322.1 Micromoles per liter (µmol/L) Standard Deviation 87.22	330.8 Micromoles per liter (µmol/L) Standard Deviation 90.07	310.6 Micromoles per liter (µmol/L) Standard Deviation 83.25
Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8 Uric acid, W8, n=66, 79, 91, 90, 86, 96	326.2 Micromoles per liter (µmol/L) Standard Deviation 104.11	318.5 Micromoles per liter (µmol/L) Standard Deviation 75.93	319.2 Micromoles per liter (µmol/L) Standard Deviation 89.12	305.8 Micromoles per liter (µmol/L) Standard Deviation 91.04	316.5 Micromoles per liter (µmol/L) Standard Deviation 92.80	322.7 Micromoles per liter (µmol/L) Standard Deviation 88.44

SECONDARY outcome

Timeframe: Baseline and Week 8/Early Withdrawal

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 Cells (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; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 1+ or 1/4 G/DL, W8, n=65, 79, 88, 90, 80, 92	0 participants	1 participants	2 participants	1 participants	1 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 3+ or 1 G/DL, W8, n=65, 79, 88, 90, 80, 92	1 participants	0 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 4+ or 2 or more G/DL, W8, n=65, 79,88,90,80,92	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Neg, W8, n=65, 79, 88, 90, 80, 92	63 participants	77 participants	83 participants	88 participants	78 participants	90 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 2+, W8, n=65, 79, 88, 90, 80, 92	0 participants	1 participants	2 participants	3 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Moderate, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Small, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Trace, W8, n=65, 79, 88, 90, 80, 92	6 participants	5 participants	7 participants	7 participants	7 participants	9 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Neg, EW, n=7, 0, 1, 4, 80, 92	7 participants	0 participants	1 participants	4 participants	5 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 1+ or 1/4 G/DL, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 2+ or 1/2 G/DL, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, 3+ or 1 G/DL, BL, n=97, 98, 96, 102, 95, 103	0 participants	2 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Neg, BL, n=97, 98, 96, 102, 95, 103	97 participants	95 participants	93 participants	99 participants	94 participants	101 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Trace or 1/10 G/DL, W8, n=65, 79, 88, 90,80,92	1 participants	0 participants	1 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, Trace, BL, n=97, 98, 96, 102, 95, 103	3 participants	1 participants	3 participants	1 participants	3 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, Trace, W8, n=65, 79, 88, 90, 80, 92	2 participants	1 participants	2 participants	4 participants	2 participants	5 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, Neg, EW, n=7, 0, 1, 4, 5, 4	7 participants	0 participants	1 participants	4 participants	5 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 2+, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	3 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 3+, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Neg, BL, n=97, 98, 96, 102, 95, 103	90 participants	84 participants	80 participants	88 participants	85 participants	82 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 1+, W8, n=65, 79, 88, 90, 80, 92	1 participants	1 participants	5 participants	5 participants	2 participants	3 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Trace, EW, n=7, 0, 1, 4, 5, 4	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 1+, BL, n=97, 98, 96, 102, 95, 103	3 participants	9 participants	4 participants	9 participants	6 participants	3 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 2+, BL, n=97, 98, 96, 102, 95, 103	1 participants	1 participants	3 participants	1 participants	3 participants	2 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 3+, BL, n=97, 98, 96, 102, 95, 103	0 participants	2 participants	1 participants	0 participants	1 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Moderate, BL, n=97, 98, 96, 102, 95, 103	1 participants	1 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Neg, BL, n=97, 98, 96, 102, 95, 103	88 participants	78 participants	83 participants	85 participants	83 participants	81 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Small, BL, n=97, 98, 96, 102, 95, 103	0 participants	2 participants	3 participants	0 participants	0 participants	2 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 3+, W8, n=65, 79, 88, 90, 80, 92	0 participants	1 participants	1 participants	1 participants	2 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Large, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 1+, EW, n=7, 0, 1, 4, 5, 4	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Small, EW, n=7, 0, 1, 4, 5, 4	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Trace, 1/10 G/DL, BL, n=97, 98, 96, 102,95,103	0 participants	1 participants	2 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Trace, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 1+, BL, n=97, 98, 96, 102, 95, 103	0 participants	3 participants	3 participants	0 participants	1 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 2+, BL, n=97, 98, 96, 102, 95, 103	3 participants	1 participants	2 participants	1 participants	3 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 3+, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	4 participants	2 participants	1 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Large, BL, n=97, 98, 96, 102, 95, 103	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Moderate, BL, n=97, 98, 96, 102, 95, 103	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Neg, BL, n=97, 98, 96, 102, 95, 103	87 participants	87 participants	81 participants	93 participants	83 participants	95 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Small, BL, n=97, 98, 96, 102, 95, 103	0 participants	2 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Trace, BL, n=97, 98, 96, 102, 95, 103	6 participants	4 participants	5 participants	5 participants	7 participants	3 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 1+, W8, n=65, 79, 88, 90, 80, 92	1 participants	0 participants	0 participants	4 participants	1 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, 3+, W8, n=65, 79, 88, 90, 80, 92	1 participants	2 participants	3 participants	2 participants	0 participants	2 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Large, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Trace, BL, n=97, 98, 96, 102, 95, 103	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UG, Neg, EW, n=7, 0, 1, 4, 80, 92	7 participants	0 participants	1 participants	4 participants	5 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, 1+, BL, n=97, 98, 96, 102, 95, 103	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UOB, Neg, W8, n=65, 79, 88, 90, 80, 92	57 participants	71 participants	75 participants	71 participants	72 participants	79 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, Neg, BL, n=97, 98, 96, 102, 95, 103	93 participants	97 participants	93 participants	101 participants	91 participants	99 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UK, Neg, W8, n=65, 79, 88, 90, 80, 92	63 participants	78 participants	86 participants	86 participants	78 participants	87 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 1+, BL, n=97, 98, 96, 102, 95, 103	3 participants	3 participants	5 participants	7 participants	3 participants	3 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Trace, BL, n=97, 98, 96, 102, 95, 103	4 participants	11 participants	8 participants	6 participants	7 participants	17 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 2+, W8, n=65, 79, 88, 90, 80, 92	2 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, 3+, W8, n=65, 79, 88, 90, 80, 92	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Neg, W8, n=65, 79, 88, 90, 80, 92	56 participants	69 participants	77 participants	77 participants	71 participants	81 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Trace, W8, n=65, 79, 88, 90, 80, 92	6 participants	9 participants	6 participants	7 participants	7 participants	7 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UP, Neg, EW, n=7, 0, 1, 4, 5, 4	6 participants	0 participants	0 participants	4 participants	5 participants	4 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Trace, BL, n=97, 98, 96, 102, 95, 103	4 participants	5 participants	2 participants	6 participants	2 participants	11 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 1+, W8, n=65, 79, 88, 90, 80, 92	3 participants	5 participants	5 participants	8 participants	4 participants	8 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, 2+, W8, n=65, 79, 88, 90, 80, 92	0 participants	1 participants	0 participants	2 participants	5 participants	5 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Moderate, W8, n=65, 79, 88, 90, 80, 92	1 participants	1 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Neg, W8, n=65, 79, 88, 90, 80, 92	58 participants	69 participants	75 participants	72 participants	65 participants	71 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Small, W8, n=65, 79, 88, 90, 80, 92	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Trace, W8, n=65, 79, 88, 90, 80, 92	2 participants	2 participants	6 participants	6 participants	4 participants	5 participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal UWBC, Neg, EW, n=7, 0, 1, 4, 5, 4	4 participants	0 participants	1 participants	4 participants	5 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 8/Early Withdrawal

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal Baseline, n=97, 98, 96, 102, 95, 103	1.0221 ratio Standard Deviation 0.00721	1.0232 ratio Standard Deviation 0.00762	1.0217 ratio Standard Deviation 0.00786	1.0223 ratio Standard Deviation 0.00653	1.0210 ratio Standard Deviation 0.00692	1.0218 ratio Standard Deviation 0.00774
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal Week 8, n=65, 79, 88, 90, 80, 92	1.0223 ratio Standard Deviation 0.00633	1.0214 ratio Standard Deviation 0.00690	1.0223 ratio Standard Deviation 0.00730	1.0230 ratio Standard Deviation 0.00680	1.0214 ratio Standard Deviation 0.00702	1.0228 ratio Standard Deviation 0.00813
Urine Specific Gravity at Baseline and Week 8/Early Withdrawal EW, n=7, 0, 1, 4, 5, 4	1.0203 ratio Standard Deviation 0.00685	NA ratio Standard Deviation NA No participants were analyzed for this treatment arm at this time point.	1.0380 ratio Standard Deviation NA A standard deviation cannot be calculated for a single participant.	1.0255 ratio Standard Deviation 0.00311	1.0200 ratio Standard Deviation 0.00863	1.0233 ratio Standard Deviation 0.00506

SECONDARY outcome

Timeframe: Baseline and Week 8/Early Withdrawal

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Urine pH at Baseline and Week 8/Early Withdrawal Baseline, n=97, 98, 96, 102, 95, 103	6.01 scores on a scale Standard Deviation 0.405	5.93 scores on a scale Standard Deviation 0.429	6.01 scores on a scale Standard Deviation 0.441	6.00 scores on a scale Standard Deviation 0.482	5.92 scores on a scale Standard Deviation 0.486	5.88 scores on a scale Standard Deviation 0.415
Urine pH at Baseline and Week 8/Early Withdrawal Week 8, n=65, 79, 88, 90, 80, 92	6.11 scores on a scale Standard Deviation 0.534	6.00 scores on a scale Standard Deviation 0.416	5.91 scores on a scale Standard Deviation 0.469	5.97 scores on a scale Standard Deviation 0.494	5.98 scores on a scale Standard Deviation 0.493	6.04 scores on a scale Standard Deviation 0.464
Urine pH at Baseline and Week 8/Early Withdrawal EW, n=7, 0, 1, 4, 5, 4	5.71 scores on a scale Standard Deviation 0.267	NA scores on a scale Standard Deviation NA No participants were analyzed for this treatment arm at this time point.	6.00 scores on a scale Standard Deviation NA A standard deviation cannot be calculated for a single participant.	5.88 scores on a scale Standard Deviation 0.479	5.60 scores on a scale Standard Deviation 0.418	5.88 scores on a scale Standard Deviation 0.250

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results

A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=71 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=74 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=71 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=66 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=80 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
24-hour Urinary Cortisol Excretion at Baseline and Week 8 Baseline	52.55 Nanomoles per 24 hours (nmol/24 hours) Interval 5.2 to 273.8	66.00 Nanomoles per 24 hours (nmol/24 hours) Interval 3.6 to 362.0	54.65 Nanomoles per 24 hours (nmol/24 hours) Interval 6.3 to 662.4	67.50 Nanomoles per 24 hours (nmol/24 hours) Interval 12.2 to 694.8	51.30 Nanomoles per 24 hours (nmol/24 hours) Interval 9.7 to 182.4	70.12 Nanomoles per 24 hours (nmol/24 hours) Interval 7.4 to 282.0
24-hour Urinary Cortisol Excretion at Baseline and Week 8 Week 8	51.79 Nanomoles per 24 hours (nmol/24 hours) Interval 2.8 to 253.2	69.40 Nanomoles per 24 hours (nmol/24 hours) Interval 4.2 to 244.8	55.19 Nanomoles per 24 hours (nmol/24 hours) Interval 3.0 to 374.5	49.80 Nanomoles per 24 hours (nmol/24 hours) Interval 4.0 to 345.4	22.99 Nanomoles per 24 hours (nmol/24 hours) Interval 2.7 to 252.0	62.35 Nanomoles per 24 hours (nmol/24 hours) Interval 7.2 to 1441.3

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Change from Baseline was calculated as the Week 8 value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=82 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=93 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=95 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=86 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=97 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 SBP	-0.4 Millimeters of mercury (mmHg) Standard Deviation 11.17	-1.2 Millimeters of mercury (mmHg) Standard Deviation 9.96	-1.9 Millimeters of mercury (mmHg) Standard Deviation 9.56	-0.8 Millimeters of mercury (mmHg) Standard Deviation 11.07	0.0 Millimeters of mercury (mmHg) Standard Deviation 11.57	-2.8 Millimeters of mercury (mmHg) Standard Deviation 11.32
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 DBP	1.0 Millimeters of mercury (mmHg) Standard Deviation 8.28	-1.0 Millimeters of mercury (mmHg) Standard Deviation 8.36	-0.9 Millimeters of mercury (mmHg) Standard Deviation 8.37	1.7 Millimeters of mercury (mmHg) Standard Deviation 7.74	1.8 Millimeters of mercury (mmHg) Standard Deviation 8.72	-1.5 Millimeters of mercury (mmHg) Standard Deviation 9.48

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Change from Baseline was calculated as the Week 8 value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=82 Participants Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=93 Participants Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=95 Participants Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=86 Participants Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=97 Participants Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Change From Baseline in Heart Rate at Week 8	0.7 Beats per minute Standard Deviation 8.07	-0.8 Beats per minute Standard Deviation 9.40	0.2 Beats per minute Standard Deviation 8.89	-0.1 Beats per minute Standard Deviation 8.70	-0.4 Beats per minute Standard Deviation 8.24	-0.0 Beats per minute Standard Deviation 8.60

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

GW685698X 200 µg OD

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

GW685698X 400 µg OD

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

GW685698X 600 µg OD

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

GW685698X 800 µg OD

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

FP 500 µg BID

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=103 participants at risk 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 participants at risk Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 participants at risk Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 participants at risk Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 participants at risk Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 participants at risk Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Infections and infestations Gastrointestinal infection	0.00% 0/103 • 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). 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.	1.0% 1/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/110 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
Infections and infestations Pneumonia	0.00% 0/103 • 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). 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.	1.0% 1/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/110 • 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). 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.97% 1/103 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.91% 1/110 • 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). 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.
Injury, poisoning and procedural complications Overdose	0.00% 0/103 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.93% 1/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.91% 1/110 • 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). 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.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/103 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/110 • 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). 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.
Psychiatric disorders Suicide attempt	0.00% 0/103 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.91% 1/110 • 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). 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.

Other adverse events

Other adverse events
Measure	Placebo n=103 participants at risk 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 200 µg OD n=99 participants at risk Participants received GW685698X 200 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 400 µg OD n=101 participants at risk Participants received GW685698X 400 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 600 µg OD n=107 participants at risk Participants received GW685698X 600 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	GW685698X 800 µg OD n=102 participants at risk Participants received GW685698X 800 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.	FP 500 µg BID n=110 participants at risk Participants received fluticasone propionate (FP) 500 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. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
Nervous system disorders Headache	9.7% 10/103 • 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). 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.	3.0% 3/99 • 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). 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.	9.9% 10/101 • 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). 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.	11.2% 12/107 • 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). 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.	9.8% 10/102 • 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). 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.	9.1% 10/110 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
Infections and infestations Nasopharyngitis	3.9% 4/103 • 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). 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.	3.0% 3/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	5.0% 5/101 • 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). 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.	1.9% 2/107 • 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). 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.	6.9% 7/102 • 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). 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.	3.6% 4/110 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
Infections and infestations Oropharyngeal candidiasis	0.97% 1/103 • 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). 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.	4.0% 4/99 • 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). 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.	4.0% 4/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.93% 1/107 • 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). 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.	3.9% 4/102 • 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). 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.	3.6% 4/110 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
Infections and infestations Oral candidiasis	0.00% 0/103 • 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). 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.	2.0% 2/99 • 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). 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.	2.0% 2/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.93% 1/107 • 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). 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.	6.9% 7/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/110 • 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). 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.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.97% 1/103 • 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). 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.	4.0% 4/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	5.0% 5/101 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.93% 1/107 • 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). 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.	3.9% 4/102 • 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). 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.	1.8% 2/110 • 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). 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.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.97% 1/103 • 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). 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.	2.0% 2/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/101 • 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). 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.	2.8% 3/107 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.98% 1/102 • 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). 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.	3.6% 4/110 • 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). 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.
Musculoskeletal and connective tissue disorders Back pain	0.97% 1/103 • 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). 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.	1.0% 1/99 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.99% 1/101 • 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). 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.	3.7% 4/107 • 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). 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.	2.0% 2/102 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.	0.00% 0/110 • 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). SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.

Additional Information

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