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The study will measure the early and late asthamtic response using an allergen challenge. This study will evaluate the safety and patients tolerance to repeat inhaled doses of GW870086X using a number of clinical and biological markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13 day repeat dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW870086X | Drug | Investigational product |
| |
| FP |
| Measure | Description | Time Frame |
|---|---|---|
| Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | 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). | 4-10 hours after allergen challenge on Day 13 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wiesbaden | Hesse | 65187 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bareille P, Allen A, Hardes K, Donald A. Effect of repeat inhaled doses of GW870086 on the allergen-induced early and late asthmatic response in subjects with mild asthma. Curr Drug Ther. 2013;8(2) |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110762 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 4-10 hours after allergen challenge on Day 13 of each treatment period |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C581038 | GW870086X |
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| Drug |
Positive control |
|
| Placebo | Drug | Placebo control |
|
| 4-10 hours after allergen challenge on Day 13 of each treatment period |
| EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 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. | 0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks) |
| Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 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. | Day 13 of each treatment period (approximately 17 weeks) |
| Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period | 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. | Day 13 of each treatment period (approximately 17 weeks) |
| Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | 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. | Up to 17 weeks |
| Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Values for Heart Rate | 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). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Number of Participants With Electrocardiogram (ECG) Findings | 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. | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Change From Baseline in FEV1-allergen Challenge at Each Time Point | 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. | Up to Day 13 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Change From Baseline in FEV1-non Allergen Challenge | 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. | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Hematocrit | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Mean Corpuscle Volume (MCV) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Reticulocytes | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Albumin and Total Protein | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | 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). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | 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). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | Up to Day 14 of each treatment period (approximately 17 weeks) |
| Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA) | 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. | Day 14 of each treatment period (approximately 17 weeks) |
| Hanover |
| Lower Saxony |
| 30625 |
| Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Berlin | 14050 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110762 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Placebo | 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. |
| OG001 | GW870086 0.25 mg OD | 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. |
| OG002 | GW870086 1 mg OD | 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. |
| OG003 | GW870086 3 mg OD | 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. |
| OG004 | Fluticasone Propionate 0.25 mg BID | 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. |
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| Secondary | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 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). | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 4-10 hours after allergen challenge on Day 13 of each treatment period |
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| Secondary | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 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. | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks) |
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| Secondary | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 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. | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Parts Per Billion | Day 13 of each treatment period (approximately 17 weeks) |
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| Secondary | Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period | 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. | All subject population. The results were not collected for exhaled NO post-dose on Day 13. | Posted | Day 13 of each treatment period (approximately 17 weeks) |
|
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| Secondary | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | 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. | All subject population. | Posted | Count of Participants | Participants | Up to 17 weeks |
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| Secondary | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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). | 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). | Posted | Mean | Standard Deviation | Millimeters of mercury | Up to Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Mean Values for Heart Rate | 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). | 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). | Posted | Mean | Standard Deviation | Beats per minute | Up to Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Findings | 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. | 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). | Posted | Count of Participants | Participants | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
| Secondary | Change From Baseline in FEV1-allergen Challenge at Each Time Point | 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. | 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). | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Up to Day 13 of each treatment period (approximately 17 weeks) |
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| Secondary | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Giga cells per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Change From Baseline in FEV1-non Allergen Challenge | 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. | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Grams per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Hematocrit | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Ratio | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Picograms | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
| Secondary | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Femtoliters | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
| Secondary | Mean Laboratory Values for Reticulocytes | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Trillion cells per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Albumin and Total Protein | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Grams per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | 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). | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | International unit per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | 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). | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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|
|
| Secondary | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). | All subject population. All participants were present at the time of assessment. | Posted | Mean | Standard Deviation | Millimoles per liter | Up to Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 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. | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | milligrams per milliliter | Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils | 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. | All subject population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | 10^4 cells per milliliter of sputum | Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 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. | All subject population. All participants were present at the time of assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picograms per milliliter | Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 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. | All subject population. All participants were present at the time of assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 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. | All subject population. All participants were present at the time of assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Day 14 of each treatment period (approximately 17 weeks) |
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| Secondary | Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA) | 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. | 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. | Posted | Day 14 of each treatment period (approximately 17 weeks) |
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | GW870086 0.25 mg OD | 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG002 | GW870086 1 mg OD | 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. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG003 | GW870086 3 mg OD | 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG004 | Fluticasone Propionate 0.25 mg BID | 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. | 0 | 12 | 0 | 12 | 3 | 12 |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Mean Difference (Net) |
| 0.154 |
| Standard Error of the Mean |
| 0.0988 |
| 2-Sided |
| 95 |
| -0.046 |
| 0.354 |
| Superiority or Other |
| Mean Difference (Net) | 0.303 | Standard Error of the Mean | 0.0937 | 2-Sided | 95 | 0.113 | 0.492 | Superiority or Other |
| Mean Difference (Net) | 0.404 | Standard Error of the Mean | 0.0966 | 2-Sided | 95 | 0.209 | 0.599 | Superiority or Other |
| Weighted Mean FEV1 |
|
| Mean Difference (Net) |
| 0.106 |
| Standard Error of the Mean |
| 0.1391 |
| 2-Sided |
| 95 |
| -0.176 |
| 0.387 |
Comparison of Minimum FEV1 between Placebo and GW870086 1 mg. |
| Superiority or Other |
| Mean Difference (Net) | 0.239 | Standard Error of the Mean | 0.1319 | 2-Sided | 95 | -0.028 | 0.506 | Comparison of Minimum FEV1 between Placebo and GW870086 3 mg. | Superiority or Other |
| Mean Difference (Net) | 0.534 | Standard Error of the Mean | 0.1359 | 2-Sided | 95 | 0.260 | 0.809 | Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID. | Superiority or Other |
| Mean Difference (Net) | 0.054 | Standard Error of the Mean | 0.0984 | 2-Sided | 95 | -0.145 | 0.253 | Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg. | Superiority or Other |
| Mean Difference (Net) | 0.026 | Standard Error of the Mean | 0.0998 | 2-Sided | 95 | -0.176 | 0.228 | Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg. | Superiority or Other |
| Mean Difference (Net) | 0.180 | Standard Error of the Mean | 0.0945 | 2-Sided | 95 | -0.011 | 0.371 | Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg. | Superiority or Other |
| Mean Difference (Net) | 0.350 | Standard Error of the Mean | 0.0978 | 2-Sided | 95 | 0.153 | 0.548 | Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID. | Superiority or Other |
| Ratio of adjusted geometric mean |
| 0.66 |
| Standard Error of the Mean |
| 0.107 |
| 2-Sided |
| 95 |
| 0.53 |
| 0.82 |
| Superiority or Other |
| Ratio of adjusted geometric mean | 0.59 | Standard Error of the Mean | 0.112 | 2-Sided | 95 | 0.47 | 0.74 | Superiority or Other |
| Ratio of adjusted geometric mean | 0.45 | Standard Error of the Mean | 0.107 | 2-Sided | 95 | 0.36 | 0.55 | Superiority or Other |
| Any AE |
|
| Any SAE |
|
| DBP-Day 1, 1h Post dose, n=24,12,12,12,12 |
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| DBP-Day 7, Post dose, n=23,11,12,12,12 |
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| DBP-Day 13, Pre saline, n=24,12,12,12,12 |
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| DBP-Day 14, Pre challenge, n=23,12,12,12,12 |
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| DBP-Day 14, 1h Post challenge, n=21,11,11,12,12 |
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| SBP-Day 1, Pre dose, n=24,12,12,12,12 |
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| SBP-Day 1, 1h Post dose, n=24,12,12,12,12 |
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| SBP-Day 7, Post dose, n=23,11,12,12,12 |
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| SBP-Day 13, Pre saline, n=24,12,12,12,12 |
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| SBP-Day 14, Pre challenge, n=23,12,12,12,12 |
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| SBP-Day 14, 1h Post challenge, n=21,11,11,12,12 |
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| HR-Day 1, 1h Post dose, n=24,12,12,12,12 |
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| HR-Day 7, Post dose, n=23,11,12,12,12 |
|
| HR-Day 13, Pre saline, n=24,12,12,12,12 |
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| HR-Day 14, Pre challenge, n=23,12,12,12,12 |
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| HR-Day 14, 1h Post challenge, n=21,11,11,12,12 |
|
| D1,Pre dose,ANCS,n=24,12,12,12,12 |
|
| D1,Pre dose,ACS,n=24,12,12,12,12 |
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| D1,1h Post dose,Nr,n=23,12,12,12,12 |
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| D1,1h Post dose,ANCS,n=23,12,12,12,12 |
|
| D1,1h Post dose,ACS,n=23,12,12,12,12 |
|
| D14,Pre challenge,Nr,n=24,12,12,12,12 |
|
| D14,Pre challenge,ANCS,n=24,12,12,12,12 |
|
| D14,Pre challenge,ACS,n=24,12,12,12,12 |
|
| D14,1h Post challenge,Nr,n=21,11,11,12,12 |
|
| D14,1h Post challenge,ANCS,n=21,11,11,12,12 |
|
| D14,1h Post challenge,ACS,n=21,11,11,12,12 |
|
| FEV1-10minutes, n=22,12,11,12,12 |
|
| FEV1-15minutes, n=22,12,10,12,12 |
|
| FEV1-20minutes, n=21,12,11,12,12 |
|
| FEV1-30minutes, n=22,12,11,12,12 |
|
| FEV1-45minutes, n=22,12,11,12,12 |
|
| FEV1-1hour, n=22,12,11,12,12 |
|
| FEV1-1.5hours, n=22,12,11,12,12 |
|
| FEV1-2hours, n=22,12,11,12,12 |
|
| FEV1-2.5hours, n=21,12,11,12,12 |
|
| FEV1-3hours, n=22,12,11,12,12 |
|
| FEV1-3.5hours, n=22,12,11,12,12 |
|
| FEV1-4hours, n=22,12,11,12,12 |
|
| FEV1-4.5hours, n=22,12,11,12,12 |
|
| FEV1-5hours, n=22,12,11,12,12 |
|
| FEV1-5.5hours, n=22,12,11,12,12 |
|
| FEV1-6hours, n=22,12,11,12,12 |
|
| FEV1-6.5hours, n=22,12,11,12,12 |
|
| FEV1-7hours, n=22,12,11,12,12 |
|
| FEV1-7.5hours, n=22,12,11,12,12 |
|
| FEV1-8hours, n=22,12,11,12,12 |
|
| FEV1-8.5hours, n=22,12,11,12,12 |
|
| FEV1-9hours, n=22,12,11,12,12 |
|
| FEV1-9.5hours, n=22,12,11,12,12 |
|
| FEV1-10hours, n=22,12,11,12,12 |
|
| Mean Difference (Net) |
| 0.164 |
| Standard Error of the Mean |
| 0.1285 |
| 2-Sided |
| 95 |
| -0.096 |
| 0.424 |
Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes |
| Superiority or Other |
| Mean Difference (Net) | 0.024 | Standard Error of the Mean | 0.1526 | 2-Sided | 95 | -0.285 | 0.333 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes | Superiority or Other |
| Mean Difference (Net) | 0.069 | Standard Error of the Mean | 0.1471 | 2-Sided | 95 | -0.229 | 0.366 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes | Superiority or Other |
| Mean Difference (Net) | -0.011 | Standard Error of the Mean | 0.1313 | 2-Sided | 95 | -0.277 | 0.254 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes | Superiority or Other |
| Mean Difference (Net) | 0.016 | Standard Error of the Mean | 0.1410 | 2-Sided | 95 | -0.269 | 0.302 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes | Superiority or Other |
| Mean Difference (Net) | 0.046 | Standard Error of the Mean | 0.1265 | 2-Sided | 95 | -0.210 | 0.301 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour | Superiority or Other |
| Mean Difference (Net) | 0.045 | Standard Error of the Mean | 0.1102 | 2-Sided | 95 | -0.178 | 0.268 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.096 | Standard Error of the Mean | 0.0985 | 2-Sided | 95 | -0.103 | 0.295 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours | Superiority or Other |
| Mean Difference (Net) | 0.045 | Standard Error of the Mean | 0.0826 | 2-Sided | 95 | -0.121 | 0.212 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.027 | Standard Error of the Mean | 0.0832 | 2-Sided | 95 | -0.141 | 0.196 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours | Superiority or Other |
| Mean Difference (Net) | 0.042 | Standard Error of the Mean | 0.0888 | 2-Sided | 95 | -0.138 | 0.221 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours | Superiority or Other |
| Mean Difference (Net) | -0.027 | Standard Error of the Mean | 0.0934 | 2-Sided | 95 | -0.215 | 0.162 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour | Superiority or Other |
| Mean Difference (Net) | 0.139 | Standard Error of the Mean | 0.1065 | 2-Sided | 95 | -0.076 | 0.354 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.149 | Standard Error of the Mean | 0.0955 | 2-Sided | 95 | -0.044 | 0.342 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours | Superiority or Other |
| Mean Difference (Net) | 0.084 | Standard Error of the Mean | 0.1005 | 2-Sided | 95 | -0.119 | 0.288 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.212 | Standard Error of the Mean | 0.1122 | 2-Sided | 95 | -0.015 | 0.438 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours | Superiority or Other |
| Mean Difference (Net) | 0.162 | Standard Error of the Mean | 0.1051 | 2-Sided | 95 | -0.051 | 0.374 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.222 | Standard Error of the Mean | 0.1181 | 2-Sided | 95 | -0.017 | 0.461 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour | Superiority or Other |
| Mean Difference (Net) | 0.185 | Standard Error of the Mean | 0.1355 | 2-Sided | 95 | -0.089 | 0.458 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.247 | Standard Error of the Mean | 0.1187 | 2-Sided | 95 | 0.007 | 0.487 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours | Superiority or Other |
| Mean Difference (Net) | 0.244 | Standard Error of the Mean | 0.1313 | 2-Sided | 95 | -0.021 | 0.509 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.154 | Standard Error of the Mean | 0.1189 | 2-Sided | 95 | -0.086 | 0.394 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours | Superiority or Other |
| Mean Difference (Net) | 0.175 | Standard Error of the Mean | 0.1085 | 2-Sided | 95 | -0.044 | 0.394 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.085 | Standard Error of the Mean | 0.1024 | 2-Sided | 95 | -0.122 | 0.292 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours | Superiority or Other |
| Mean Difference (Net) | 0.072 | Standard Error of the Mean | 0.1125 | 2-Sided | 95 | -0.155 | 0.300 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes | Superiority or Other |
| Mean Difference (Net) | 0.051 | Standard Error of the Mean | 0.1303 | 2-Sided | 95 | -0.213 | 0.314 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes | Superiority or Other |
| Mean Difference (Net) | 0.142 | Standard Error of the Mean | 0.1572 | 2-Sided | 95 | -0.176 | 0.461 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes | Superiority or Other |
| Mean Difference (Net) | 0.094 | Standard Error of the Mean | 0.1494 | 2-Sided | 95 | -0.208 | 0.396 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes | Superiority or Other |
| Mean Difference (Net) | 0.058 | Standard Error of the Mean | 0.1332 | 2-Sided | 95 | -0.212 | 0.327 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes | Superiority or Other |
| Mean Difference (Net) | 0.065 | Standard Error of the Mean | 0.1430 | 2-Sided | 95 | -0.224 | 0.354 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes | Superiority or Other |
| Mean Difference (Net) | -0.016 | Standard Error of the Mean | 0.1283 | 2-Sided | 95 | -0.276 | 0.243 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour | Superiority or Other |
| Mean Difference (Net) | 0.017 | Standard Error of the Mean | 0.1118 | 2-Sided | 95 | -0.209 | 0.244 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours | Superiority or Other |
| Mean Difference (Net) | -0.148 | Standard Error of the Mean | 0.0998 | 2-Sided | 95 | -0.350 | 0.053 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours | Superiority or Other |
| Mean Difference (Net) | -0.086 | Standard Error of the Mean | 0.0829 | 2-Sided | 95 | -0.253 | 0.082 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours | Superiority or Other |
| Mean Difference (Net) | -0.040 | Standard Error of the Mean | 0.0843 | 2-Sided | 95 | -0.211 | 0.130 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours | Superiority or Other |
| Mean Difference (Net) | 0.020 | Standard Error of the Mean | 0.0900 | 2-Sided | 95 | -0.161 | 0.202 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours | Superiority or Other |
| Mean Difference (Net) | -0.005 | Standard Error of the Mean | 0.0947 | 2-Sided | 95 | -0.196 | 0.186 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour | Superiority or Other |
| Mean Difference (Net) | 0.113 | Standard Error of the Mean | 0.1079 | 2-Sided | 95 | -0.105 | 0.330 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.130 | Standard Error of the Mean | 0.0968 | 2-Sided | 95 | -0.065 | 0.326 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours | Superiority or Other |
| Mean Difference (Net) | -0.007 | Standard Error of the Mean | 0.1019 | 2-Sided | 95 | -0.213 | 0.199 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.178 | Standard Error of the Mean | 0.1138 | 2-Sided | 95 | -0.052 | 0.407 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours | Superiority or Other |
| Mean Difference (Net) | 0.135 | Standard Error of the Mean | 0.1065 | 2-Sided | 95 | -0.080 | 0.351 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.179 | Standard Error of the Mean | 0.1198 | 2-Sided | 95 | -0.062 | 0.421 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour | Superiority or Other |
| Mean Difference (Net) | 0.146 | Standard Error of the Mean | 0.1373 | 2-Sided | 95 | -0.131 | 0.423 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.168 | Standard Error of the Mean | 0.1203 | 2-Sided | 95 | -0.075 | 0.411 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours | Superiority or Other |
| Mean Difference (Net) | 0.222 | Standard Error of the Mean | 0.1331 | 2-Sided | 95 | -0.047 | 0.490 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.143 | Standard Error of the Mean | 0.1206 | 2-Sided | 95 | -0.100 | 0.387 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours | Superiority or Other |
| Mean Difference (Net) | 0.187 | Standard Error of the Mean | 0.1100 | 2-Sided | 95 | -0.035 | 0.410 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.168 | Standard Error of the Mean | 0.1039 | 2-Sided | 95 | -0.042 | 0.378 | Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours | Superiority or Other |
| Mean Difference (Net) | 0.221 | Standard Error of the Mean | 0.1036 | 2-Sided | 95 | 0.011 | 0.431 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes | Superiority or Other |
| Mean Difference (Net) | 0.244 | Standard Error of the Mean | 0.1236 | 2-Sided | 95 | -0.006 | 0.494 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes | Superiority or Other |
| Mean Difference (Net) | 0.255 | Standard Error of the Mean | 0.1445 | 2-Sided | 95 | -0.038 | 0.548 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes | Superiority or Other |
| Mean Difference (Net) | 0.233 | Standard Error of the Mean | 0.1436 | 2-Sided | 95 | -0.057 | 0.524 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes | Superiority or Other |
| Mean Difference (Net) | 0.219 | Standard Error of the Mean | 0.1262 | 2-Sided | 95 | -0.036 | 0.474 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes | Superiority or Other |
| Mean Difference (Net) | 0.294 | Standard Error of the Mean | 0.1355 | 2-Sided | 95 | 0.019 | 0.568 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes | Superiority or Other |
| Mean Difference (Net) | 0.227 | Standard Error of the Mean | 0.1216 | 2-Sided | 95 | -0.019 | 0.473 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour | Superiority or Other |
| Mean Difference (Net) | 0.204 | Standard Error of the Mean | 0.1059 | 2-Sided | 95 | -0.010 | 0.418 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.116 | Standard Error of the Mean | 0.0947 | 2-Sided | 95 | -0.075 | 0.308 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours | Superiority or Other |
| Mean Difference (Net) | 0.027 | Standard Error of the Mean | 0.0805 | 2-Sided | 95 | -0.136 | 0.190 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.046 | Standard Error of the Mean | 0.0801 | 2-Sided | 95 | -0.116 | 0.208 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours | Superiority or Other |
| Mean Difference (Net) | 0.074 | Standard Error of the Mean | 0.0855 | 2-Sided | 95 | -0.099 | 0.247 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour | Superiority or Other |
| Mean Difference (Net) | 0.131 | Standard Error of the Mean | 0.0900 | 2-Sided | 95 | -0.051 | 0.313 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours | Superiority or Other |
| Mean Difference (Net) | 0.204 | Standard Error of the Mean | 0.1025 | 2-Sided | 95 | -0.004 | 0.411 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.181 | Standard Error of the Mean | 0.0918 | 2-Sided | 95 | -0.004 | 0.367 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours | Superiority or Other |
| Mean Difference (Net) | 0.178 | Standard Error of the Mean | 0.0967 | 2-Sided | 95 | -0.018 | 0.373 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.288 | Standard Error of the Mean | 0.1079 | 2-Sided | 95 | 0.070 | 0.506 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours | Superiority or Other |
| Mean Difference (Net) | 0.283 | Standard Error of the Mean | 0.1011 | 2-Sided | 95 | 0.079 | 0.488 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.386 | Standard Error of the Mean | 0.1137 | 2-Sided | 95 | 0.157 | 0.616 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour | Superiority or Other |
| Mean Difference (Net) | 0.372 | Standard Error of the Mean | 0.1306 | 2-Sided | 95 | 0.108 | 0.636 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.458 | Standard Error of the Mean | 0.1142 | 2-Sided | 95 | 0.227 | 0.688 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours | Superiority or Other |
| Mean Difference (Net) | 0.509 | Standard Error of the Mean | 0.1264 | 2-Sided | 95 | 0.254 | 0.765 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.492 | Standard Error of the Mean | 0.1144 | 2-Sided | 95 | 0.261 | 0.723 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours | Superiority or Other |
| Mean Difference (Net) | 0.414 | Standard Error of the Mean | 0.1042 | 2-Sided | 95 | 0.203 | 0.625 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.440 | Standard Error of the Mean | 0.0984 | 2-Sided | 95 | 0.241 | 0.639 | Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours | Superiority or Other |
| Mean Difference (Net) | 0.348 | Standard Error of the Mean | 0.1056 | 2-Sided | 95 | 0.135 | 0.562 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes | Superiority or Other |
| Mean Difference (Net) | 0.494 | Standard Error of the Mean | 0.1273 | 2-Sided | 95 | 0.237 | 0.751 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes | Superiority or Other |
| Mean Difference (Net) | 0.499 | Standard Error of the Mean | 0.1484 | 2-Sided | 95 | 0.199 | 0.800 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes | Superiority or Other |
| Mean Difference (Net) | 0.573 | Standard Error of the Mean | 0.1481 | 2-Sided | 95 | 0.274 | 0.872 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes | Superiority or Other |
| Mean Difference (Net) | 0.488 | Standard Error of the Mean | 0.1303 | 2-Sided | 95 | 0.225 | 0.751 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes | Superiority or Other |
| Mean Difference (Net) | 0.380 | Standard Error of the Mean | 0.1398 | 2-Sided | 95 | 0.098 | 0.663 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes | Superiority or Other |
| Mean Difference (Net) | 0.342 | Standard Error of the Mean | 0.1254 | 2-Sided | 95 | 0.089 | 0.596 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour | Superiority or Other |
| Mean Difference (Net) | 0.218 | Standard Error of the Mean | 0.1094 | 2-Sided | 95 | -0.003 | 0.439 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.127 | Standard Error of the Mean | 0.0974 | 95 | -0.070 | 0.323 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours | Superiority or Other |
| Mean Difference (Net) | 0.058 | Standard Error of the Mean | 0.0818 | 2-Sided | 95 | -0.107 | 0.223 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours | Superiority or Other |
| Mean Difference (Net) | -0.027 | Standard Error of the Mean | 0.0821 | 2-Sided | 95 | -0.192 | 0.139 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours | Superiority or Other |
| Mean Difference (Net) | 0.091 | Standard Error of the Mean | 0.0876 | 2-Sided | 95 | -0.085 | 0.268 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.084 | Standard Error of the Mean | 0.0921 | 2-Sided | 95 | -0.102 | 0.269 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour | Superiority or Other |
| Mean Difference (Net) | 0.249 | Standard Error of the Mean | 0.1050 | 2-Sided | 95 | 0.038 | 0.461 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.238 | Standard Error of the Mean | 0.0945 | 2-Sided | 95 | 0.047 | 0.429 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours | Superiority or Other |
| Mean Difference (Net) | 0.315 | Standard Error of the Mean | 0.0995 | 2-Sided | 95 | 0.114 | 0.516 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.367 | Standard Error of the Mean | 0.1111 | 2-Sided | 95 | 0.143 | 0.591 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours | Superiority or Other |
| Mean Difference (Net) | 0.361 | Standard Error of the Mean | 0.1040 | 2-Sided | 95 | 0.151 | 0.571 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.367 | Standard Error of the Mean | 0.1168 | 2-Sided | 95 | 0.131 | 0.602 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour | Superiority or Other |
| Mean Difference (Net) | 0.424 | Standard Error of the Mean | 0.1336 | 2-Sided | 95 | 0.155 | 0.694 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.556 | Standard Error of the Mean | 0.1174 | 2-Sided | 95 | 0.319 | 0.793 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours | Superiority or Other |
| Mean Difference (Net) | 0.593 | Standard Error of the Mean | 0.1297 | 95 | 0.331 | 0.854 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.559 | Standard Error of the Mean | 0.1177 | 2-Sided | 95 | 0.322 | 0.797 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours | Superiority or Other |
| Mean Difference (Net) | 0.522 | Standard Error of the Mean | 0.1076 | 95 | 0.304 | 0.739 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours | Superiority or Other |
| Mean Difference (Net) | 0.514 | Standard Error of the Mean | 0.1017 | 95 | 0.308 | 0.719 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours | Superiority or Other |
| Basophils,Day14,pre-challenge |
|
| Eosinophils,Day1,pre-dose |
|
| Eosinophils,Day14,pre-challenge |
|
| Lymphocytes,Day1,pre-dose |
|
| Lymphocytes,Day14,pre-challenge |
|
| Monocytes,Day1,pre-dose |
|
| Monocytes,Day14,pre-challenge |
|
| Neutrophils,Day1,pre-dose |
|
| Neutrophils,Day14,pre-challenge |
|
| Platelet,Day1,pre-dose |
|
| Platelet,Day14,pre-challenge |
|
| WBC,Day1,pre-dose |
|
| WBC,Day14,pre-challenge |
|
| FEV1,Day 13,n=24,12,12,12,12 |
|
| FEV1,Day 14,n=23,12,12,12,12 |
|
| Mean Difference (Net) |
| 0.185 |
| Standard Error of the Mean |
| 0.0884 |
| 2-Sided |
| 95 |
| 0.007 |
| 0.363 |
Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13 |
| Superiority or Other |
| Mean Difference (Net) | 0.144 | Standard Error of the Mean | 0.1026 | 2-Sided | 95 | -0.062 | 0.351 | Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14 | Superiority or Other |
| Mean Difference (Net) | 0.330 | Standard Error of the Mean | 0.0979 | 2-Sided | 95 | 0.133 | 0.527 | Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7 | Superiority or Other |
| Mean Difference (Net) | 0.081 | Standard Error of the Mean | 0.0856 | 2-Sided | 95 | -0.092 | 0.253 | Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13 | Superiority or Other |
| Mean Difference (Net) | 0.126 | Standard Error of the Mean | 0.1000 | 2-Sided | 95 | -0.076 | 0.327 | Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14 | Superiority or Other |
| Mean Difference (Net) | 0.297 | Standard Error of the Mean | 0.0976 | 2-Sided | 95 | 0.100 | 0.493 | Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7 | Superiority or Other |
| Mean Difference (Net) | 0.256 | Standard Error of the Mean | 0.0859 | 2-Sided | 95 | 0.083 | 0.429 | Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13 | Superiority or Other |
| Mean Difference (Net) | 0.462 | Standard Error of the Mean | 0.0991 | 2-Sided | 95 | 0.262 | 0.662 | Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14 | Superiority or Other |
| Mean Difference (Net) | 0.323 | Standard Error of the Mean | 0.0982 | 2-Sided | 95 | 0.125 | 0.520 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7 | Superiority or Other |
| Mean Difference (Net) | 0.229 | Standard Error of the Mean | 0.0858 | 2-Sided | 95 | 0.057 | 0.402 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13 | Superiority or Other |
| Mean Difference (Net) | 0.372 | Standard Error of the Mean | 0.0991 | 2-Sided | 95 | 0.172 | 0.572 | Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14 | Superiority or Other |
| Hemoglobin,Day14,pre-challenge |
|
| MCHC,Day1,pre-dose |
|
| MCHC,Day14,pre-challenge |
|
| Hematocrit,Day14,pre-challenge |
|
| MCH,Day14,pre-challenge |
|
| MCV,Day14,pre-challenge |
|
| Reticulocytes,Day14,pre-challenge |
|
| Albumin,Day14,pre-challenge |
|
| Total protein,Day1,pre-dose |
|
| Total protein,Day14,pre-challenge |
|
| ALP,Day14,pre-challenge,n=24,12,12,12,12 |
|
| ALT,Day1,pre-dose,n=24,12,12,12,12 |
|
| ALT,Day7,pre-dose,n=23,12,12,12,12 |
|
| ALT,Day14,pre-challenge,n=24,12,12,12,12 |
|
| AST,Day1,pre-dose,n=24,12,12,12,12 |
|
| AST,Day7,pre-dose,n=23,12,12,12,12 |
|
| AST,Day14,pre-challenge,n=24,12,12,12,12 |
|
| GGT,Day1,pre-dose,n=24,12,12,12,12 |
|
| GGT,Day14,pre-challenge,n=24,12,12,12,12 |
|
| TB,Day7,pre-dose,n=23,12,12,12,12 |
|
| TB,Day14,pre-challenge,n=24,12,12,12,12 |
|
| DB,Day1,pre-dose,n=24,12,12,12,12 |
|
| DB,Day7,pre-dose,n=23,12,12,12,12 |
|
| DB,Day14,pre-challenge,n=24,12,12,12,12 |
|
| Creatinine,Day1,pre-dose,n=24,12,12,12,12 |
|
| Creatinine,Day14,pre-challenge,n=24,12,12,12,12 |
|
| Calcium,Day14,pre-challenge |
|
| Chloride,Day1,pre-dose |
|
| Chloride,Day14,pre-challenge |
|
| Glucose,Day1,pre-dose |
|
| Glucose,Day14,pre-challenge |
|
| Potassium,Day1,pre-dose |
|
| Potassium,Day14,pre-challenge |
|
| Sodium,Day1,pre-dose |
|
| Sodium,Day14,pre-challenge |
|
| Mean Difference (Final Values) |
| 0.27 |
| Standard Error of the Mean |
| 0.495 |
| 2-Sided |
| 95 |
| -0.73 |
| 1.28 |
Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1). |
| Superiority or Other |
| Mean Difference (Final Values) | 1.28 | Standard Error of the Mean | 0.450 | 2-Sided | 95 | 0.36 | 2.19 | Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1). | Superiority or Other |
| Mean Difference (Final Values) | 1.79 | Standard Error of the Mean | 0.469 | 2-Sided | 95 | 0.84 | 2.75 | Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1). | Superiority or Other |
| Neutrophils,n=17,6,7,4,10 |
|