Trial Outcomes & Findings for A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics (NCT NCT00857857)

Results Overview

Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

4-10 hours after allergen challenge on Day 13 of each treatment period

Results posted on

2018-02-20

Participant Flow

Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.

Participants with pre-bronchodilator forced expiratory volume in 1 second (FEV1) \>65% predicted at Screening, positive wheal and flare reaction (\>=3 millimeter) on skin prick testing, early asthmatic response (EAR) and late asthmatic response (LAR) had to include a fall in FEV1 of \>=20%, \>=15%, respectively from the post saline value were included.

Participant milestones

Participant milestones
Measure	Overall Study Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 milligram (mg), 1 mg, 3 mg once daily (OD), active control (fluticasone propionate 0.25 mg bi-daily \[BID\]) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as multi-dose powder inhaler (MDPI). GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=24 Participants Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 mg, 1 mg, 3 mg OD, active control (fluticasone propionate 0.25mg BID) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as MDPI. GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Age, Continuous	39.4 Years STANDARD_DEVIATION 11.25 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-10 hours after allergen challenge on Day 13 of each treatment period

Population: The all subject population was used which was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.

Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=11 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=22 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period	-0.663 Liters Interval -0.918 to -0.407	-0.638 Liters Interval -0.896 to -0.38	-0.446 Liters Interval -0.698 to -0.194	-0.376 Liters Interval -0.63 to -0.123	-0.903 Liters Interval -1.126 to -0.679

SECONDARY outcome

Timeframe: 4-10 hours after allergen challenge on Day 13 of each treatment period

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Weighted mean LAR was calculated for FEV1 over 4-10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours) post allergen challenge using the linear trapezoidal rule. To calculate weighted mean LAR, all FEV1 values recorded after the administration of rescue medication have been set to the last recorded FEV1 value prior to the administration of rescue medication. The adjusted mean is presented as Least square mean (LSM).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=11 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=22 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.	-0.340 Liters Interval -0.567 to -0.113	-0.396 Liters Interval -0.626 to -0.167	-0.248 Liters Interval -0.471 to -0.024	-0.146 Liters Interval -0.371 to 0.078	-0.550 Liters Interval -0.744 to -0.356

SECONDARY outcome

Timeframe: 0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 0-2 hrs post-allergen challenge (minimum EAR) was the minimum value of all the post-(bolus) allergen challenge. Weighted mean EAR was calculated for FEV1 over 0-2 hours post allergen challenge using the linear trapezoidal rule. It was measured up to and including 2 hours (5, 10, 15, 20, 30, 45 minutes and 1, 1.5 and 2 hours). The adjusted mean is presented as LSM.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=11 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=22 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. Minimum FEV1	-1.364 Liters Interval -1.675 to -1.052	-1.233 Liters Interval -1.549 to -0.918	-1.100 Liters Interval -1.407 to -0.794	-0.805 Liters Interval -1.113 to -0.496	-1.339 Liters Interval -1.603 to -1.075
EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. Weighted Mean FEV1	-0.760 Liters Interval -1.014 to -0.506	-0.789 Liters Interval -1.045 to -0.532	-0.634 Liters Interval -0.885 to -0.383	-0.464 Liters Interval -0.716 to -0.212	-0.814 Liters Interval -1.039 to -0.589

SECONDARY outcome

Timeframe: Day 13 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Exhaled NO concentration data collected on Day 13 (pre-dose) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The adjusted mean is presented.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=11 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period	37.76 Parts Per Billion Interval 30.98 to 46.02	34.95 Parts Per Billion Interval 28.97 to 42.16	31.18 Parts Per Billion Interval 25.62 to 37.95	23.57 Parts Per Billion Interval 19.54 to 28.43	52.91 Parts Per Billion Interval 46.1 to 60.72

SECONDARY outcome

Timeframe: Day 13 of each treatment period (approximately 17 weeks)

Population: All subject population. The results were not collected for exhaled NO post-dose on Day 13.

Exhaled NO concentration data collected on Day 13 (2 and 12 hours post-dose) and was measured 3 times at each time point. The outcome was not assessed and data not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 17 weeks

Population: All subject population.

An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) TEAE	3 Participants	5 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) Any AE	4 Participants	7 Participants	4 Participants	3 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).

Participants were required to rest in the supine position for at least 10 minutes before each reading. SBP and DBP was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge \[pre saline\]) and Day 14 (pre and 1 hour post methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 1, Pre dose, n=24,12,12,12,12	75.8 Millimeters of mercury Standard Deviation 9.26	74.7 Millimeters of mercury Standard Deviation 6.75	76.6 Millimeters of mercury Standard Deviation 6.58	73.7 Millimeters of mercury Standard Deviation 6.27	76.1 Millimeters of mercury Standard Deviation 8.63
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 1, 1h Post dose, n=24,12,12,12,12	72.3 Millimeters of mercury Standard Deviation 8.81	72.1 Millimeters of mercury Standard Deviation 5.84	74.5 Millimeters of mercury Standard Deviation 4.81	73.5 Millimeters of mercury Standard Deviation 7.50	73.8 Millimeters of mercury Standard Deviation 7.42
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 7, Post dose, n=23,11,12,12,12	75.3 Millimeters of mercury Standard Deviation 10.30	77.3 Millimeters of mercury Standard Deviation 5.71	74.8 Millimeters of mercury Standard Deviation 6.48	73.8 Millimeters of mercury Standard Deviation 7.31	74.0 Millimeters of mercury Standard Deviation 7.91
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 13, Pre saline, n=24,12,12,12,12	73.0 Millimeters of mercury Standard Deviation 6.97	75.0 Millimeters of mercury Standard Deviation 7.47	74.2 Millimeters of mercury Standard Deviation 7.36	73.5 Millimeters of mercury Standard Deviation 7.74	76.4 Millimeters of mercury Standard Deviation 7.93
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 14, Pre challenge, n=23,12,12,12,12	74.3 Millimeters of mercury Standard Deviation 9.08	77.0 Millimeters of mercury Standard Deviation 5.01	76.0 Millimeters of mercury Standard Deviation 8.80	74.8 Millimeters of mercury Standard Deviation 6.36	75.6 Millimeters of mercury Standard Deviation 8.04
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP-Day 14, 1h Post challenge, n=21,11,11,12,12	72.3 Millimeters of mercury Standard Deviation 6.86	73.5 Millimeters of mercury Standard Deviation 6.53	71.3 Millimeters of mercury Standard Deviation 7.32	72.9 Millimeters of mercury Standard Deviation 7.33	74.3 Millimeters of mercury Standard Deviation 5.59
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 1, Pre dose, n=24,12,12,12,12	119.8 Millimeters of mercury Standard Deviation 8.55	121.3 Millimeters of mercury Standard Deviation 6.53	115.8 Millimeters of mercury Standard Deviation 8.67	117.1 Millimeters of mercury Standard Deviation 7.54	120.8 Millimeters of mercury Standard Deviation 12.11
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 1, 1h Post dose, n=24,12,12,12,12	122.8 Millimeters of mercury Standard Deviation 8.14	121.5 Millimeters of mercury Standard Deviation 6.75	118.6 Millimeters of mercury Standard Deviation 9.26	119.3 Millimeters of mercury Standard Deviation 10.75	123.8 Millimeters of mercury Standard Deviation 10.34
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 7, Post dose, n=23,11,12,12,12	119.3 Millimeters of mercury Standard Deviation 7.62	119.4 Millimeters of mercury Standard Deviation 7.81	113.2 Millimeters of mercury Standard Deviation 8.77	118.7 Millimeters of mercury Standard Deviation 5.02	118.3 Millimeters of mercury Standard Deviation 11.53
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 13, Pre saline, n=24,12,12,12,12	117.6 Millimeters of mercury Standard Deviation 7.12	118.8 Millimeters of mercury Standard Deviation 9.26	120.0 Millimeters of mercury Standard Deviation 11.80	119.2 Millimeters of mercury Standard Deviation 11.92	121.9 Millimeters of mercury Standard Deviation 9.21
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 14, Pre challenge, n=23,12,12,12,12	119.1 Millimeters of mercury Standard Deviation 8.43	124.5 Millimeters of mercury Standard Deviation 10.08	116.8 Millimeters of mercury Standard Deviation 9.69	119.0 Millimeters of mercury Standard Deviation 8.61	119.7 Millimeters of mercury Standard Deviation 11.94
Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP-Day 14, 1h Post challenge, n=21,11,11,12,12	121.9 Millimeters of mercury Standard Deviation 7.23	123.7 Millimeters of mercury Standard Deviation 7.81	117.1 Millimeters of mercury Standard Deviation 8.80	119.6 Millimeters of mercury Standard Deviation 14.22	123.8 Millimeters of mercury Standard Deviation 9.50

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).

Participants were required to rest in the supine position for at least 10 minutes before each reading. Heart rate was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge) and Day 14 (pre and 1 hour post methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Values for Heart Rate HR-Day 1, Pre dose, n=24,12,12,12,12	61.7 Beats per minute Standard Deviation 8.50	62.8 Beats per minute Standard Deviation 8.68	60.5 Beats per minute Standard Deviation 6.63	58.3 Beats per minute Standard Deviation 6.37	64.5 Beats per minute Standard Deviation 8.15
Mean Values for Heart Rate HR-Day 1, 1h Post dose, n=24,12,12,12,12	68.2 Beats per minute Standard Deviation 9.76	62.7 Beats per minute Standard Deviation 9.33	60.1 Beats per minute Standard Deviation 6.71	62.1 Beats per minute Standard Deviation 6.69	66.3 Beats per minute Standard Deviation 8.87
Mean Values for Heart Rate HR-Day 7, Post dose, n=23,11,12,12,12	60.9 Beats per minute Standard Deviation 9.27	64.0 Beats per minute Standard Deviation 9.73	62.2 Beats per minute Standard Deviation 7.88	63.7 Beats per minute Standard Deviation 8.16	63.3 Beats per minute Standard Deviation 9.52
Mean Values for Heart Rate HR-Day 13, Pre saline, n=24,12,12,12,12	62.3 Beats per minute Standard Deviation 6.40	64.9 Beats per minute Standard Deviation 7.96	62.3 Beats per minute Standard Deviation 8.54	64.0 Beats per minute Standard Deviation 6.93	62.5 Beats per minute Standard Deviation 7.17
Mean Values for Heart Rate HR-Day 14, Pre challenge, n=23,12,12,12,12	64.5 Beats per minute Standard Deviation 7.68	64.9 Beats per minute Standard Deviation 5.12	63.1 Beats per minute Standard Deviation 9.76	62.1 Beats per minute Standard Deviation 6.58	63.7 Beats per minute Standard Deviation 7.83
Mean Values for Heart Rate HR-Day 14, 1h Post challenge, n=21,11,11,12,12	71.2 Beats per minute Standard Deviation 8.30	69.7 Beats per minute Standard Deviation 8.22	66.1 Beats per minute Standard Deviation 8.94	67.6 Beats per minute Standard Deviation 5.60	67.9 Beats per minute Standard Deviation 8.40

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. It was measured on Day 1 (pre-dose and 1 hour post dose) and Day 14 (pre and 1 hour post methacholine challenge). Participants with normal (Nr), abnormal not clinically significant (ANCS) and abnormal clinically significant (ACS) ECG was presented.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Number of Participants With Electrocardiogram (ECG) Findings D1,Pre dose,Nr,n=24,12,12,12,12	9 Participants	10 Participants	11 Participants	8 Participants	20 Participants
Number of Participants With Electrocardiogram (ECG) Findings D1,Pre dose,ANCS,n=24,12,12,12,12	3 Participants	2 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Electrocardiogram (ECG) Findings D1,Pre dose,ACS,n=24,12,12,12,12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings D1,1h Post dose,Nr,n=23,12,12,12,12	7 Participants	8 Participants	11 Participants	9 Participants	16 Participants
Number of Participants With Electrocardiogram (ECG) Findings D1,1h Post dose,ANCS,n=23,12,12,12,12	5 Participants	4 Participants	1 Participants	3 Participants	7 Participants
Number of Participants With Electrocardiogram (ECG) Findings D1,1h Post dose,ACS,n=23,12,12,12,12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,Pre challenge,Nr,n=24,12,12,12,12	10 Participants	10 Participants	12 Participants	11 Participants	19 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,Pre challenge,ANCS,n=24,12,12,12,12	2 Participants	2 Participants	0 Participants	1 Participants	5 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,Pre challenge,ACS,n=24,12,12,12,12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,1h Post challenge,Nr,n=21,11,11,12,12	10 Participants	10 Participants	11 Participants	11 Participants	19 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,1h Post challenge,ANCS,n=21,11,11,12,12	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Findings D14,1h Post challenge,ACS,n=21,11,11,12,12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 13 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).

A mixed model analysis was performed separately for each planned time point during the allergen challenge on Day 13, from 5 minutes to 10 hour, including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. FEV1 was measured at 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours. The adjusted mean is presented as LSM.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-5minutes, n=22,12,11,12,12	-0.765 Liters Interval -0.971 to -0.558	-0.713 Liters Interval -0.933 to -0.493	-0.565 Liters Interval -0.766 to -0.363	-0.437 Liters Interval -0.639 to -0.234	-0.785 Liters Interval -0.945 to -0.626
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-10minutes, n=22,12,11,12,12	-0.913 Liters Interval -1.202 to -0.625	-1.026 Liters Interval -1.318 to -0.734	-0.833 Liters Interval -1.116 to -0.549	-0.583 Liters Interval -0.869 to -0.298	-1.077 Liters Interval -1.32 to -0.834
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-15minutes, n=22,12,10,12,12	-1.157 Liters Interval -1.478 to -0.837	-1.039 Liters Interval -1.377 to -0.702	-0.927 Liters Interval -1.24 to -0.614	-0.682 Liters Interval -0.997 to -0.367	-1.182 Liters Interval -1.444 to -0.919
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-20minutes, n=21,12,11,12,12	-1.170 Liters Interval -1.473 to -0.867	-1.144 Liters Interval -1.451 to -0.837	-1.005 Liters Interval -1.301 to -0.709	-0.666 Liters Interval -0.965 to -0.367	-1.238 Liters Interval -1.486 to -0.991
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-30minutes, n=22,12,11,12,12	-1.212 Liters Interval -1.533 to -0.891	-1.143 Liters Interval -1.467 to -0.819	-0.982 Liters Interval -1.298 to -0.666	-0.713 Liters Interval -1.031 to -0.395	-1.201 Liters Interval -1.48 to -0.921
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-45minutes, n=22,12,11,12,12	-1.031 Liters Interval -1.361 to -0.701	-0.983 Liters Interval -1.317 to -0.649	-0.754 Liters Interval -1.079 to -0.429	-0.667 Liters Interval -0.994 to -0.34	-1.048 Liters Interval -1.331 to -0.765
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-1hour, n=22,12,11,12,12	-0.820 Liters Interval -1.122 to -0.517	-0.882 Liters Interval -1.188 to -0.576	-0.638 Liters Interval -0.936 to -0.34	-0.523 Liters Interval -0.823 to -0.223	-0.865 Liters Interval -1.127 to -0.604
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-1.5hours, n=22,12,11,12,12	-0.496 Liters Interval -0.767 to -0.225	-0.523 Liters Interval -0.797 to -0.249	-0.337 Liters Interval -0.604 to -0.069	-0.323 Liters Interval -0.592 to -0.054	-0.541 Liters Interval -0.778 to -0.304
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-2hours, n=22,12,11,12,12	-0.215 Liters Interval -0.427 to -0.002	-0.459 Liters Interval -0.675 to -0.244	-0.195 Liters Interval -0.403 to 0.014	-0.184 Liters Interval -0.395 to 0.026	-0.311 Liters Interval -0.487 to -0.135
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-2.5hours, n=21,12,11,12,12	-0.120 Liters Interval -0.29 to 0.051	-0.251 Liters Interval -0.424 to -0.077	-0.138 Liters Interval -0.306 to 0.029	-0.107 Liters Interval -0.275 to 0.061	-0.165 Liters Interval -0.306 to -0.024
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-3hours, n=22,12,11,12,12	-0.104 Liters Interval -0.274 to 0.066	-0.172 Liters Interval -0.344 to 0.001	-0.086 Liters Interval -0.252 to 0.081	-0.158 Liters Interval -0.326 to 0.009	-0.131 Liters Interval -0.268 to 0.005
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-3.5hours, n=22,12,11,12,12	-0.143 Liters Interval -0.324 to 0.038	-0.164 Liters Interval -0.348 to 0.02	-0.111 Liters Interval -0.288 to 0.067	-0.093 Liters Interval -0.272 to 0.086	-0.184 Liters Interval -0.33 to -0.039
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-4hours, n=22,12,11,12,12	-0.222 Liters Interval -0.409 to -0.036	-0.201 Liters Interval -0.39 to -0.012	-0.065 Liters Interval -0.247 to 0.118	-0.112 Liters Interval -0.296 to 0.072	-0.196 Liters Interval -0.344 to -0.048
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-4.5hours, n=22,12,11,12,12	-0.201 Liters Interval -0.418 to 0.015	-0.228 Liters Interval -0.448 to -0.008	-0.137 Liters Interval -0.349 to 0.076	-0.091 Liters Interval -0.305 to 0.123	-0.341 Liters Interval -0.515 to -0.166
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-5hours, n=22,12,11,12,12	-0.227 Liters Interval -0.439 to -0.016	-0.246 Liters Interval -0.46 to -0.032	-0.195 Liters Interval -0.403 to 0.013	-0.139 Liters Interval -0.348 to 0.071	-0.376 Liters Interval -0.554 to -0.199
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-5.5hours, n=22,12,11,12,12	-0.310 Liters Interval -0.534 to -0.086	-0.401 Liters Interval -0.628 to -0.174	-0.216 Liters Interval -0.437 to 0.004	-0.079 Liters Interval -0.301 to 0.143	-0.394 Liters Interval -0.583 to -0.206
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-6hours, n=22,12,11,12,12	-0.308 Liters Interval -0.559 to -0.056	-0.342 Liters Interval -0.596 to -0.087	-0.231 Liters Interval -0.478 to 0.016	-0.152 Liters Interval -0.401 to 0.096	-0.519 Liters Interval -0.731 to -0.308
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-6.5hours, n=22,12,11,12,12	-0.366 Liters Interval -0.598 to -0.135	-0.393 Liters Interval -0.627 to -0.158	-0.245 Liters Interval -0.472 to -0.018	-0.167 Liters Interval -0.396 to 0.062	-0.528 Liters Interval -0.721 to -0.335
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-7hours, n=22,12,11,12,12	-0.366 Liters Interval -0.618 to -0.114	-0.409 Liters Interval -0.665 to -0.153	-0.202 Liters Interval -0.449 to 0.045	-0.222 Liters Interval -0.471 to 0.027	-0.589 Liters Interval -0.796 to -0.381
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-7.5hours, n=22,12,11,12,12	-0.403 Liters Interval -0.674 to -0.132	-0.442 Liters Interval -0.717 to -0.166	-0.216 Liters Interval -0.481 to 0.05	-0.163 Liters Interval -0.43 to 0.104	-0.587 Liters Interval -0.803 to -0.372
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-8hours, n=22,12,11,12,12	-0.401 Liters Interval -0.662 to -0.141	-0.481 Liters Interval -0.745 to -0.216	-0.191 Liters Interval -0.447 to 0.065	-0.092 Liters Interval -0.35 to 0.166	-0.648 Liters Interval -0.866 to -0.431
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-8.5hours, n=22,12,11,12,12	-0.423 Liters Interval -0.699 to -0.148	-0.446 Liters Interval -0.725 to -0.167	-0.158 Liters Interval -0.428 to 0.112	-0.075 Liters Interval -0.347 to 0.197	-0.668 Liters Interval -0.892 to -0.443
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-9hours, n=22,12,11,12,12	-0.498 Liters Interval -0.765 to -0.231	-0.509 Liters Interval -0.78 to -0.238	-0.160 Liters Interval -0.423 to 0.103	-0.093 Liters Interval -0.358 to 0.172	-0.652 Liters Interval -0.878 to -0.427
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-9.5hours, n=22,12,11,12,12	-0.485 Liters Interval -0.75 to -0.221	-0.473 Liters Interval -0.74 to -0.205	-0.246 Liters Interval -0.507 to 0.015	-0.139 Liters Interval -0.401 to 0.124	-0.660 Liters Interval -0.891 to -0.43
Change From Baseline in FEV1-allergen Challenge at Each Time Point FEV1-10hours, n=22,12,11,12,12	-0.562 Liters Interval -0.821 to -0.302	-0.478 Liters Interval -0.74 to -0.216	-0.206 Liters Interval -0.462 to 0.05	-0.133 Liters Interval -0.39 to 0.125	-0.646 Liters Interval -0.875 to -0.418

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils,Day1,pre-dose	0.025 Giga cells per liter Standard Deviation 0.0117	0.022 Giga cells per liter Standard Deviation 0.0094	0.016 Giga cells per liter Standard Deviation 0.0090	0.021 Giga cells per liter Standard Deviation 0.0079	0.027 Giga cells per liter Standard Deviation 0.0123
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Basophils,Day14,pre-challenge	0.020 Giga cells per liter Standard Deviation 0.0113	0.027 Giga cells per liter Standard Deviation 0.0107	0.018 Giga cells per liter Standard Deviation 0.0094	0.023 Giga cells per liter Standard Deviation 0.0089	0.021 Giga cells per liter Standard Deviation 0.0118
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils,Day1,pre-dose	0.289 Giga cells per liter Standard Deviation 0.1451	0.429 Giga cells per liter Standard Deviation 0.2930	0.308 Giga cells per liter Standard Deviation 0.1579	0.459 Giga cells per liter Standard Deviation 0.3528	0.417 Giga cells per liter Standard Deviation 0.2395
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Eosinophils,Day14,pre-challenge	0.411 Giga cells per liter Standard Deviation 0.1399	0.482 Giga cells per liter Standard Deviation 0.2291	0.320 Giga cells per liter Standard Deviation 0.1587	0.346 Giga cells per liter Standard Deviation 0.2143	0.516 Giga cells per liter Standard Deviation 0.2579
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes,Day1,pre-dose	1.948 Giga cells per liter Standard Deviation 0.4525	2.100 Giga cells per liter Standard Deviation 0.6834	1.688 Giga cells per liter Standard Deviation 0.4350	1.574 Giga cells per liter Standard Deviation 0.3542	1.792 Giga cells per liter Standard Deviation 0.5462
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Lymphocytes,Day14,pre-challenge	1.872 Giga cells per liter Standard Deviation 0.4693	1.771 Giga cells per liter Standard Deviation 0.4827	1.599 Giga cells per liter Standard Deviation 0.5361	1.619 Giga cells per liter Standard Deviation 0.3474	1.676 Giga cells per liter Standard Deviation 0.4461
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes,Day1,pre-dose	0.393 Giga cells per liter Standard Deviation 0.1277	0.340 Giga cells per liter Standard Deviation 0.1041	0.329 Giga cells per liter Standard Deviation 0.0598	0.338 Giga cells per liter Standard Deviation 0.1024	0.384 Giga cells per liter Standard Deviation 0.1283
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Monocytes,Day14,pre-challenge	0.378 Giga cells per liter Standard Deviation 0.1100	0.382 Giga cells per liter Standard Deviation 0.1712	0.355 Giga cells per liter Standard Deviation 0.1313	0.364 Giga cells per liter Standard Deviation 0.1125	0.362 Giga cells per liter Standard Deviation 0.0909
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils,Day1,pre-dose	3.829 Giga cells per liter Standard Deviation 1.7236	2.966 Giga cells per liter Standard Deviation 1.1941	2.811 Giga cells per liter Standard Deviation 0.4711	3.251 Giga cells per liter Standard Deviation 1.1947	3.258 Giga cells per liter Standard Deviation 1.1745
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Neutrophils,Day14,pre-challenge	3.209 Giga cells per liter Standard Deviation 0.8137	3.557 Giga cells per liter Standard Deviation 1.3102	3.182 Giga cells per liter Standard Deviation 0.7059	3.288 Giga cells per liter Standard Deviation 1.0353	3.572 Giga cells per liter Standard Deviation 1.4247
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelet,Day1,pre-dose	240.3 Giga cells per liter Standard Deviation 42.02	247.3 Giga cells per liter Standard Deviation 47.10	229.6 Giga cells per liter Standard Deviation 28.27	238.8 Giga cells per liter Standard Deviation 51.34	233.9 Giga cells per liter Standard Deviation 35.20
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Platelet,Day14,pre-challenge	220.3 Giga cells per liter Standard Deviation 28.04	230.4 Giga cells per liter Standard Deviation 24.21	229.0 Giga cells per liter Standard Deviation 30.64	220.8 Giga cells per liter Standard Deviation 33.76	230.3 Giga cells per liter Standard Deviation 31.03
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC,Day1,pre-dose	6.48 Giga cells per liter Standard Deviation 1.582	5.86 Giga cells per liter Standard Deviation 1.405	5.15 Giga cells per liter Standard Deviation 0.672	5.64 Giga cells per liter Standard Deviation 1.439	5.88 Giga cells per liter Standard Deviation 1.598
Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils WBC,Day14,pre-challenge	5.89 Giga cells per liter Standard Deviation 1.124	6.22 Giga cells per liter Standard Deviation 1.681	5.48 Giga cells per liter Standard Deviation 1.008	5.64 Giga cells per liter Standard Deviation 1.158	6.15 Giga cells per liter Standard Deviation 1.865

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Non-allergen challenge FEV1 data was measured on Day 1, 7, 13 and 14. The FEV1 assessments on Day 1 was taken at pre-dose and those on Day 7 was taken post-dose. On Day 13, the pre-allergen challenge FEV1 values was used and on Day 14 the pre-methacholine challenge FEV1 values was used. Absolute change in FEV1 on Day 7, 13 and 14 from pre-dose FEV1 was analyzed separately using a mixed-effects ANOVA model. Period-level Baseline was defined as the difference between the Day 1 pre-dose value and participant-level Baseline for each period, each participant. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value. Post-randomization values refer to assessments performed post dose and after the Baseline assessment. The adjusted mean is presented as LSM.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Change From Baseline in FEV1-non Allergen Challenge FEV1,Day 7,n=23,11,12,12,12	0.185 Liters Interval 0.006 to 0.364	0.221 Liters Interval 0.054 to 0.387	0.187 Liters Interval 0.021 to 0.353	0.213 Liters Interval 0.046 to 0.38	-0.110 Liters Interval -0.229 to 0.01
Change From Baseline in FEV1-non Allergen Challenge FEV1,Day 13,n=24,12,12,12,12	0.212 Liters Interval 0.046 to 0.378	0.108 Liters Interval -0.055 to 0.27	0.283 Liters Interval 0.12 to 0.445	0.256 Liters Interval 0.093 to 0.419	0.027 Liters Interval -0.095 to 0.149
Change From Baseline in FEV1-non Allergen Challenge FEV1,Day 14,n=23,12,12,12,12	-0.181 Liters Interval -0.372 to 0.011	-0.199 Liters Interval -0.387 to -0.011	0.137 Liters Interval -0.05 to 0.324	0.047 Liters Interval -0.141 to 0.235	-0.325 Liters Interval -0.468 to -0.182

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin,Day1,pre-dose	151.8 Grams per liter Standard Deviation 7.58	147.1 Grams per liter Standard Deviation 10.01	145.2 Grams per liter Standard Deviation 6.52	147.2 Grams per liter Standard Deviation 6.01	149.0 Grams per liter Standard Deviation 9.04
Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Hemoglobin,Day14,pre-challenge	150.3 Grams per liter Standard Deviation 10.23	148.6 Grams per liter Standard Deviation 9.79	140.8 Grams per liter Standard Deviation 9.11	147.4 Grams per liter Standard Deviation 8.14	147.1 Grams per liter Standard Deviation 10.16
Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC,Day1,pre-dose	335.9 Grams per liter Standard Deviation 6.04	336.3 Grams per liter Standard Deviation 5.74	334.6 Grams per liter Standard Deviation 7.24	336.3 Grams per liter Standard Deviation 4.23	335.0 Grams per liter Standard Deviation 5.43
Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) MCHC,Day14,pre-challenge	335.8 Grams per liter Standard Deviation 5.80	337.9 Grams per liter Standard Deviation 5.73	333.5 Grams per liter Standard Deviation 5.57	335.7 Grams per liter Standard Deviation 6.64	335.7 Grams per liter Standard Deviation 4.97

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Hematocrit Hematocrit,Day1,pre-dose	0.4519 Ratio Standard Deviation 0.02474	0.4369 Ratio Standard Deviation 0.02850	0.4341 Ratio Standard Deviation 0.01919	0.4376 Ratio Standard Deviation 0.02114	0.4445 Ratio Standard Deviation 0.02631
Mean Laboratory Values for Hematocrit Hematocrit,Day14,pre-challenge	0.4476 Ratio Standard Deviation 0.03070	0.4396 Ratio Standard Deviation 0.02950	0.4225 Ratio Standard Deviation 0.02418	0.4391 Ratio Standard Deviation 0.02880	0.4383 Ratio Standard Deviation 0.02929

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) MCH,Day1,pre-dose	31.23 Picograms Standard Deviation 1.577	30.93 Picograms Standard Deviation 1.652	30.86 Picograms Standard Deviation 1.053	30.58 Picograms Standard Deviation 1.652	30.84 Picograms Standard Deviation 1.473
Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) MCH,Day14,pre-challenge	31.19 Picograms Standard Deviation 1.576	30.92 Picograms Standard Deviation 1.634	30.89 Picograms Standard Deviation 0.961	30.57 Picograms Standard Deviation 1.629	30.87 Picograms Standard Deviation 1.512

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Mean Corpuscle Volume (MCV) MCV,Day1,pre-dose	93.0 Femtoliters Standard Deviation 4.43	92.0 Femtoliters Standard Deviation 4.57	92.3 Femtoliters Standard Deviation 2.96	91.0 Femtoliters Standard Deviation 5.39	92.1 Femtoliters Standard Deviation 4.87
Mean Laboratory Values for Mean Corpuscle Volume (MCV) MCV,Day14,pre-challenge	93.0 Femtoliters Standard Deviation 3.84	91.5 Femtoliters Standard Deviation 4.42	92.8 Femtoliters Standard Deviation 2.89	91.2 Femtoliters Standard Deviation 5.52	92.0 Femtoliters Standard Deviation 4.53

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=11 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Reticulocytes Reticulocytes,Day1,pre-dose	0.04708 Trillion cells per liter Standard Deviation 0.026433	0.04941 Trillion cells per liter Standard Deviation 0.027213	0.05176 Trillion cells per liter Standard Deviation 0.016041	0.05268 Trillion cells per liter Standard Deviation 0.017560	0.04626 Trillion cells per liter Standard Deviation 0.027363
Mean Laboratory Values for Reticulocytes Reticulocytes,Day14,pre-challenge	0.05613 Trillion cells per liter Standard Deviation 0.026415	0.04720 Trillion cells per liter Standard Deviation 0.020698	0.04565 Trillion cells per liter Standard Deviation 0.017335	0.05543 Trillion cells per liter Standard Deviation 0.029142	0.04574 Trillion cells per liter Standard Deviation 0.016707

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Albumin and Total Protein Albumin,Day1,pre-dose	45.5 Grams per liter Standard Deviation 2.94	45.2 Grams per liter Standard Deviation 2.98	45.7 Grams per liter Standard Deviation 2.23	45.3 Grams per liter Standard Deviation 3.42	45.4 Grams per liter Standard Deviation 2.41
Mean Laboratory Values for Albumin and Total Protein Albumin,Day14,pre-challenge	44.5 Grams per liter Standard Deviation 2.15	44.6 Grams per liter Standard Deviation 2.43	44.6 Grams per liter Standard Deviation 1.73	44.8 Grams per liter Standard Deviation 2.25	44.5 Grams per liter Standard Deviation 2.47
Mean Laboratory Values for Albumin and Total Protein Total protein,Day1,pre-dose	71.3 Grams per liter Standard Deviation 3.96	68.8 Grams per liter Standard Deviation 2.80	70.0 Grams per liter Standard Deviation 3.10	70.6 Grams per liter Standard Deviation 2.81	70.6 Grams per liter Standard Deviation 3.48
Mean Laboratory Values for Albumin and Total Protein Total protein,Day14,pre-challenge	69.6 Grams per liter Standard Deviation 3.20	67.8 Grams per liter Standard Deviation 3.01	68.2 Grams per liter Standard Deviation 3.76	69.6 Grams per liter Standard Deviation 3.03	69.3 Grams per liter Standard Deviation 3.60

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Liver safety parameters (ALT and AST) were also assessed on Day 7 (pre-dose).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP,Day1,pre-dose,n=24,12,12,12,12	61.5 International unit per liter Standard Deviation 11.12	57.3 International unit per liter Standard Deviation 15.03	54.6 International unit per liter Standard Deviation 18.08	64.1 International unit per liter Standard Deviation 11.33	60.8 International unit per liter Standard Deviation 15.08
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALP,Day14,pre-challenge,n=24,12,12,12,12	61.2 International unit per liter Standard Deviation 13.71	55.6 International unit per liter Standard Deviation 14.64	53.3 International unit per liter Standard Deviation 17.39	63.7 International unit per liter Standard Deviation 9.70	58.8 International unit per liter Standard Deviation 14.52
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT,Day7,pre-dose,n=23,12,12,12,12	18.8 International unit per liter Standard Deviation 7.45	19.5 International unit per liter Standard Deviation 6.23	17.4 International unit per liter Standard Deviation 6.88	18.7 International unit per liter Standard Deviation 4.16	19.6 International unit per liter Standard Deviation 6.28
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT,Day14,pre-challenge,n=24,12,12,12,12	18.2 International unit per liter Standard Deviation 7.06	18.4 International unit per liter Standard Deviation 4.10	16.8 International unit per liter Standard Deviation 8.16	20.3 International unit per liter Standard Deviation 5.77	18.3 International unit per liter Standard Deviation 7.83
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST,Day1,pre-dose,n=24,12,12,12,12	19.1 International unit per liter Standard Deviation 4.50	19.4 International unit per liter Standard Deviation 3.80	19.3 International unit per liter Standard Deviation 5.93	23.8 International unit per liter Standard Deviation 5.42	21.3 International unit per liter Standard Deviation 6.01
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST,Day7,pre-dose,n=23,12,12,12,12	19.5 International unit per liter Standard Deviation 4.93	20.0 International unit per liter Standard Deviation 3.69	18.7 International unit per liter Standard Deviation 4.12	20.3 International unit per liter Standard Deviation 3.60	20.1 International unit per liter Standard Deviation 4.48
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) AST,Day14,pre-challenge,n=24,12,12,12,12	18.6 International unit per liter Standard Deviation 4.72	19.3 International unit per liter Standard Deviation 3.92	17.8 International unit per liter Standard Deviation 4.65	21.1 International unit per liter Standard Deviation 5.16	18.5 International unit per liter Standard Deviation 4.74
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT,Day1,pre-dose,n=24,12,12,12,12	29.4 International unit per liter Standard Deviation 14.98	25.9 International unit per liter Standard Deviation 7.69	24.5 International unit per liter Standard Deviation 18.25	31.5 International unit per liter Standard Deviation 19.76	30.0 International unit per liter Standard Deviation 22.30
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) GGT,Day14,pre-challenge,n=24,12,12,12,12	28.3 International unit per liter Standard Deviation 13.94	24.9 International unit per liter Standard Deviation 6.95	23.3 International unit per liter Standard Deviation 15.77	31.1 International unit per liter Standard Deviation 19.78	28.8 International unit per liter Standard Deviation 17.64
Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) ALT,Day1,pre-dose,n=24,12,12,12,12	17.8 International unit per liter Standard Deviation 7.72	18.9 International unit per liter Standard Deviation 5.37	17.6 International unit per liter Standard Deviation 7.32	21.3 International unit per liter Standard Deviation 5.90	20.6 International unit per liter Standard Deviation 7.41

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Total bilirubin and direct bilirubin were also assessed on Day 7 (pre-dose).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine TB,Day1,pre-dose,n=24,12,12,12,12	13.9 Micromoles per liter Standard Deviation 6.08	12.6 Micromoles per liter Standard Deviation 5.50	11.8 Micromoles per liter Standard Deviation 2.90	14.7 Micromoles per liter Standard Deviation 5.50	13.7 Micromoles per liter Standard Deviation 7.06
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine TB,Day7,pre-dose,n=23,12,12,12,12	12.5 Micromoles per liter Standard Deviation 6.24	11.8 Micromoles per liter Standard Deviation 5.24	10.3 Micromoles per liter Standard Deviation 4.29	12.6 Micromoles per liter Standard Deviation 5.43	11.3 Micromoles per liter Standard Deviation 5.18
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine TB,Day14,pre-challenge,n=24,12,12,12,12	11.4 Micromoles per liter Standard Deviation 5.81	12.7 Micromoles per liter Standard Deviation 5.99	11.5 Micromoles per liter Standard Deviation 4.54	11.7 Micromoles per liter Standard Deviation 4.87	11.4 Micromoles per liter Standard Deviation 3.70
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine DB,Day1,pre-dose,n=24,12,12,12,12	2.5 Micromoles per liter Standard Deviation 1.09	2.3 Micromoles per liter Standard Deviation 0.97	2.0 Micromoles per liter Standard Deviation 0.74	2.5 Micromoles per liter Standard Deviation 1.17	2.5 Micromoles per liter Standard Deviation 1.44
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine DB,Day7,pre-dose,n=23,12,12,12,12	2.2 Micromoles per liter Standard Deviation 1.47	1.9 Micromoles per liter Standard Deviation 0.90	1.9 Micromoles per liter Standard Deviation 1.00	2.5 Micromoles per liter Standard Deviation 1.09	2.2 Micromoles per liter Standard Deviation 1.34
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine DB,Day14,pre-challenge,n=24,12,12,12,12	2.0 Micromoles per liter Standard Deviation 1.13	1.9 Micromoles per liter Standard Deviation 1.16	2.0 Micromoles per liter Standard Deviation 0.85	2.3 Micromoles per liter Standard Deviation 0.87	2.0 Micromoles per liter Standard Deviation 0.86
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine Creatinine,Day1,pre-dose,n=24,12,12,12,12	89.2 Micromoles per liter Standard Deviation 7.91	85.8 Micromoles per liter Standard Deviation 10.38	89.3 Micromoles per liter Standard Deviation 11.83	86.5 Micromoles per liter Standard Deviation 9.89	90.7 Micromoles per liter Standard Deviation 9.73
Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine Creatinine,Day14,pre-challenge,n=24,12,12,12,12	87.2 Micromoles per liter Standard Deviation 13.91	84.3 Micromoles per liter Standard Deviation 13.47	89.6 Micromoles per liter Standard Deviation 11.91	86.8 Micromoles per liter Standard Deviation 10.06	87.3 Micromoles per liter Standard Deviation 9.46

SECONDARY outcome

Timeframe: Up to Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Calcium,Day1,pre-dose	2.377 Millimoles per liter Standard Deviation 0.0873	2.338 Millimoles per liter Standard Deviation 0.0591	2.358 Millimoles per liter Standard Deviation 0.0618	2.364 Millimoles per liter Standard Deviation 0.0710	2.354 Millimoles per liter Standard Deviation 0.0618
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Calcium,Day14,pre-challenge	2.343 Millimoles per liter Standard Deviation 0.0568	2.327 Millimoles per liter Standard Deviation 0.0627	2.324 Millimoles per liter Standard Deviation 0.0562	2.334 Millimoles per liter Standard Deviation 0.0566	2.355 Millimoles per liter Standard Deviation 0.0896
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Chloride,Day1,pre-dose	103.7 Millimoles per liter Standard Deviation 2.02	103.8 Millimoles per liter Standard Deviation 2.59	104.0 Millimoles per liter Standard Deviation 1.21	103.8 Millimoles per liter Standard Deviation 2.05	103.8 Millimoles per liter Standard Deviation 1.84
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Chloride,Day14,pre-challenge	104.5 Millimoles per liter Standard Deviation 1.68	104.6 Millimoles per liter Standard Deviation 1.73	104.9 Millimoles per liter Standard Deviation 2.39	104.4 Millimoles per liter Standard Deviation 1.62	104.7 Millimoles per liter Standard Deviation 2.42
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Glucose,Day1,pre-dose	5.04 Millimoles per liter Standard Deviation 0.425	5.51 Millimoles per liter Standard Deviation 0.950	4.87 Millimoles per liter Standard Deviation 0.375	5.15 Millimoles per liter Standard Deviation 0.768	5.10 Millimoles per liter Standard Deviation 0.443
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Glucose,Day14,pre-challenge	5.09 Millimoles per liter Standard Deviation 0.429	5.23 Millimoles per liter Standard Deviation 1.052	4.98 Millimoles per liter Standard Deviation 0.283	5.32 Millimoles per liter Standard Deviation 0.949	5.18 Millimoles per liter Standard Deviation 0.832
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Potassium,Day1,pre-dose	4.35 Millimoles per liter Standard Deviation 0.224	4.28 Millimoles per liter Standard Deviation 0.205	4.32 Millimoles per liter Standard Deviation 0.279	4.39 Millimoles per liter Standard Deviation 0.250	4.38 Millimoles per liter Standard Deviation 0.304
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Potassium,Day14,pre-challenge	4.27 Millimoles per liter Standard Deviation 0.257	4.20 Millimoles per liter Standard Deviation 0.338	4.36 Millimoles per liter Standard Deviation 0.239	4.31 Millimoles per liter Standard Deviation 0.375	4.35 Millimoles per liter Standard Deviation 0.320
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Sodium,Day1,pre-dose	139.2 Millimoles per liter Standard Deviation 2.17	139.1 Millimoles per liter Standard Deviation 1.38	139.7 Millimoles per liter Standard Deviation 1.83	139.4 Millimoles per liter Standard Deviation 1.83	139.8 Millimoles per liter Standard Deviation 2.04
Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium Sodium,Day14,pre-challenge	139.3 Millimoles per liter Standard Deviation 2.19	140.4 Millimoles per liter Standard Deviation 1.24	139.6 Millimoles per liter Standard Deviation 1.51	140.3 Millimoles per liter Standard Deviation 2.14	140.2 Millimoles per liter Standard Deviation 1.93

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Methacholine challenge PC20 data the concentration of methacholine to cause \>= 20% decrease (that is change \<= -20%) in FEV1 compared with saline \[Baseline\]) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The PC20 was obtained by linear interpolation (on the log 2 concentration scale) between the lowest concentration of methacholine that caused at least 20% decrease from Baseline and the preceding concentration. The adjusted mean is presented as LSM.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=9 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=9 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=11 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=10 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=19 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.	0.22 milligrams per milliliter Interval 0.12 to 1.51	0.33 milligrams per milliliter Interval 0.18 to 1.86	0.66 milligrams per milliliter Interval 0.38 to 3.2	0.95 milligrams per milliliter Interval 0.52 to 5.56	0.27 milligrams per milliliter Interval 0.18 to 1.53

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. Only those participants with data available at the indicated time points were analyzed.

Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=12 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=24 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils Eosinophils,n=17,6,6,4,10	0.015 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 1038.7	0.015 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 309.4	0.007 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 464.2	0.008 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 222.0	0.024 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 1175.3
Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils Neutrophils,n=17,6,7,4,10	0.086 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 3070.0	0.069 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 228.3	0.134 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 555.9	0.053 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 280.8	0.064 10^4 cells per milliliter of sputum Geometric Coefficient of Variation 1115.2

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=7 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=8 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=7 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=10 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=19 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)	330.822 Picograms per milliliter Geometric Coefficient of Variation 165.6	205.906 Picograms per milliliter Geometric Coefficient of Variation 73.5	287.877 Picograms per milliliter Geometric Coefficient of Variation 85.3	251.286 Picograms per milliliter Geometric Coefficient of Variation 131.0	260.246 Picograms per milliliter Geometric Coefficient of Variation 93.0

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=7 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=8 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=7 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=10 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=19 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)	1252.473 Nanograms per milliliter Geometric Coefficient of Variation 57.9	470.412 Nanograms per milliliter Geometric Coefficient of Variation 64.2	408.389 Nanograms per milliliter Geometric Coefficient of Variation 127.2	820.154 Nanograms per milliliter Geometric Coefficient of Variation 202.6	863.936 Nanograms per milliliter Geometric Coefficient of Variation 162.7

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. All participants were present at the time of assessment.

Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.

Outcome measures

Outcome measures
Measure	GW870086 0.25 mg OD n=7 Participants Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=8 Participants Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=7 Participants Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=10 Participants Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.	Placebo n=19 Participants Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.
Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein	264.893 Micrograms per milliliter Geometric Coefficient of Variation 40.6	193.891 Micrograms per milliliter Geometric Coefficient of Variation 38.5	263.454 Micrograms per milliliter Geometric Coefficient of Variation 167.9	342.683 Micrograms per milliliter Geometric Coefficient of Variation 122.8	232.218 Micrograms per milliliter Geometric Coefficient of Variation 54.8

SECONDARY outcome

Timeframe: Day 14 of each treatment period (approximately 17 weeks)

Population: All subject population. A GSK file note, dated 02 April 2009, was used to document that mRNA would no longer be collected from the sputum samples. This was due to the fact that a suitable laboratory could not be identified to carry out the analysis.

Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study. The outcome is not assessed.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

GW870086 0.25 mg OD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

GW870086 1 mg OD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

GW870086 3 mg OD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Fluticasone Propionate 0.25 mg BID

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=24 participants at risk Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.	GW870086 0.25 mg OD n=12 participants at risk Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.	GW870086 1 mg OD n=12 participants at risk Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	GW870086 3 mg OD n=12 participants at risk Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.	Fluticasone Propionate 0.25 mg BID n=12 participants at risk Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.
Nervous system disorders Headache	12.5% 3/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	50.0% 6/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Nervous system disorders Migraine	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Infections and infestations Nasopharyngitis	8.3% 2/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	25.0% 3/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Infections and infestations Herpes simplex	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Infections and infestations Oral herpes	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Respiratory, thoracic and mediastinal disorders Bronchospasm	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	16.7% 2/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Respiratory, thoracic and mediastinal disorders Asthma	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Gastrointestinal disorders Nausea	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Gastrointestinal disorders Oral pain	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Eye disorders Conjunctivitis	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Injury, poisoning and procedural complications Skin laceration	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Reproductive system and breast disorders Prostatitis	4.2% 1/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	8.3% 1/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.	0.00% 0/12 • AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks) All subject population used.

Additional Information

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