Asthma
Conditions
Keywords
asthma, late phase response, allergen, challenge, GW870086X
Brief summary
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects between 18 and 65 years of age inclusive. * Male subjects must agree to use one of the contraception methods listed in Section 8. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose. * BMI within the range 19.0 - 29.0 kg/m2 (inclusive). * Liver function tests (bilirubin, AST, ALT) within normal laboratory parameters at screening. * Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation. * Pre-bronchodilator FEV1 \>65% of predicted at screening. * No history of smoking within 6 months of the start of the study, and with a total pack year history of \<= 10 pack years * Demonstration of a positive wheal and flare reaction (\>= 3 mm relative to negative control) to at least one allergen from a battery of allergens (including but not limited to house dust mite, grass pollen, cat dander, hazel, horse and birch) on skin prick testing at screening, or within 12 months of study start. * Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of \>= 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of \>= 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen. * Reproducible allergen challenge at screening (confirmation of the dose ascending allergen challenge by a bolus allergen challenge at least 14 days later). * Sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of \<8 mg/mL at screening. * Subjects who are able to produce acceptable induced sputum samples (as defined in the Study Procedures Manual). * Be able to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Single QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
Exclusion criteria
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). * Clinically significant abnormalities in safety laboratory analysis at screening. * Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP \>140mmHg or diastolic BP \> 90mmHg. * Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. * History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. * Administration of oral, injectable or dermal steroids within 4 weeks or intranasal and/or inhaled steroids within 2 week of the screening visit. * The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. * A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. * A positive test for HIV antibody. * History of regular alcohol consumption within 6 months of the study defined as: 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. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up. * Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-agonists within 1 week prior to screening and is unable to abstain from them throughout the study. * Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma (not including steroids), anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 7 days before screening until the follow-up visit. * Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazol from screening and throughout the study. * Unable to use the DISKHALER and/or DISKUS device correctly. * History of being unable to tolerate or complete methacholine or allergen challenge tests. * If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%. * Subject is undergoing allergen desensitisation therapy. * History of sensitivity to any of the study medications (including lactose), or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. * Unwillingness or inability to follow the procedures outlined in the protocol. * Subjects who are kept due to regulatory or juridical order in an institution. * Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. * Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks) | 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. |
| Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | Day 13 of each treatment period (approximately 17 weeks) | 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. |
| Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period | Day 13 of each treatment period (approximately 17 weeks) | 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. |
| Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Up to 17 weeks | 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. |
| Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to Day 14 of each treatment period (approximately 17 weeks) | 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). |
| Mean Values for Heart Rate | Up to Day 14 of each treatment period (approximately 17 weeks) | 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). |
| Number of Participants With Electrocardiogram (ECG) Findings | Up to Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Change From Baseline in FEV1-allergen Challenge at Each Time Point | Up to Day 13 of each treatment period (approximately 17 weeks) | 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. |
| Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Change From Baseline in FEV1-non Allergen Challenge | Up to Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Mean Laboratory Values for Hematocrit | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | 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). |
| Mean Laboratory Values for Mean Corpuscle Volume (MCV) | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Mean Laboratory Values for Reticulocytes | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Mean Laboratory Values for Albumin and Total Protein | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | Up to Day 14 of each treatment period (approximately 17 weeks) | 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). |
| Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Up to Day 14 of each treatment period (approximately 17 weeks) | 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). |
| Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
| Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA) | Day 14 of each treatment period (approximately 17 weeks) | 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. |
| Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | Up to Day 14 of each treatment period (approximately 17 weeks) | Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). |
Countries
Germany
Participant flow
Recruitment details
Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 11.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 8 / 24 | 4 / 12 | 7 / 12 | 4 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 24 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | -0.903 Liters |
| GW870086 0.25 mg OD | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | -0.663 Liters |
| GW870086 1 mg OD | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | -0.638 Liters |
| GW870086 3 mg OD | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | -0.446 Liters |
| Fluticasone Propionate 0.25 mg BID | Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period | -0.376 Liters |
95% CI: [0.031, 0.449]
95% CI: [0.053, 0.477]
95% CI: [0.255, 0.657]
95% CI: [0.319, 0.733]
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | 0.024 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 1175.3 |
| Placebo | 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 | 0.064 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 1115.2 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | 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 309.4 |
| GW870086 1 mg OD | 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 | 0.069 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 228.3 |
| GW870086 3 mg OD | 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 | 0.134 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 555.9 |
| GW870086 3 mg OD | 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 | 0.007 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 464.2 |
| Fluticasone Propionate 0.25 mg BID | 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 | 0.008 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 222 |
| Fluticasone Propionate 0.25 mg BID | 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 | 0.053 10^4 cells per milliliter of sputum | Geometric Coefficient of Variation 280.8 |
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.
Time frame: Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 863.936 Nanograms per milliliter | Geometric Coefficient of Variation 162.7 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 470.412 Nanograms per milliliter | Geometric Coefficient of Variation 64.2 |
| GW870086 3 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 408.389 Nanograms per milliliter | Geometric Coefficient of Variation 127.2 |
| Fluticasone Propionate 0.25 mg BID | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8) | 820.154 Nanograms per milliliter | Geometric Coefficient of Variation 202.6 |
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.
Time frame: Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 260.246 Picograms per milliliter | Geometric Coefficient of Variation 93 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 205.906 Picograms per milliliter | Geometric Coefficient of Variation 73.5 |
| GW870086 3 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 287.877 Picograms per milliliter | Geometric Coefficient of Variation 85.3 |
| Fluticasone Propionate 0.25 mg BID | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO) | 251.286 Picograms per milliliter | Geometric Coefficient of Variation 131 |
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.
Time frame: Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 232.218 Micrograms per milliliter | Geometric Coefficient of Variation 54.8 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 193.891 Micrograms per milliliter | Geometric Coefficient of Variation 38.5 |
| GW870086 3 mg OD | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 263.454 Micrograms per milliliter | Geometric Coefficient of Variation 167.9 |
| Fluticasone Propionate 0.25 mg BID | Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein | 342.683 Micrograms per milliliter | Geometric Coefficient of Variation 122.8 |
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.
Time frame: 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).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-45minutes, n=22,12,11,12,12 | -1.048 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4.5hours, n=22,12,11,12,12 | -0.341 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9hours, n=22,12,11,12,12 | -0.652 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-20minutes, n=21,12,11,12,12 | -1.238 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7.5hours, n=22,12,11,12,12 | -0.587 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1hour, n=22,12,11,12,12 | -0.865 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5.5hours, n=22,12,11,12,12 | -0.394 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10hours, n=22,12,11,12,12 | -0.646 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4hours, n=22,12,11,12,12 | -0.196 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7hours, n=22,12,11,12,12 | -0.589 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1.5hours, n=22,12,11,12,12 | -0.541 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8.5hours, n=22,12,11,12,12 | -0.668 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-30minutes, n=22,12,11,12,12 | -1.201 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3.5hours, n=22,12,11,12,12 | -0.184 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6.5hours, n=22,12,11,12,12 | -0.528 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2hours, n=22,12,11,12,12 | -0.311 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10minutes, n=22,12,11,12,12 | -1.077 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9.5hours, n=22,12,11,12,12 | -0.660 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5hours, n=22,12,11,12,12 | -0.376 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6hours, n=22,12,11,12,12 | -0.519 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2.5hours, n=21,12,11,12,12 | -0.165 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8hours, n=22,12,11,12,12 | -0.648 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-15minutes, n=22,12,10,12,12 | -1.182 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5minutes, n=22,12,11,12,12 | -0.785 Liters |
| Placebo | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3hours, n=22,12,11,12,12 | -0.131 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5.5hours, n=22,12,11,12,12 | -0.310 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3hours, n=22,12,11,12,12 | -0.104 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-15minutes, n=22,12,10,12,12 | -1.157 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5hours, n=22,12,11,12,12 | -0.227 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3.5hours, n=22,12,11,12,12 | -0.143 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10hours, n=22,12,11,12,12 | -0.562 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4.5hours, n=22,12,11,12,12 | -0.201 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4hours, n=22,12,11,12,12 | -0.222 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9hours, n=22,12,11,12,12 | -0.498 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-20minutes, n=21,12,11,12,12 | -1.170 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8.5hours, n=22,12,11,12,12 | -0.423 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-30minutes, n=22,12,11,12,12 | -1.212 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8hours, n=22,12,11,12,12 | -0.401 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-45minutes, n=22,12,11,12,12 | -1.031 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10minutes, n=22,12,11,12,12 | -0.913 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7.5hours, n=22,12,11,12,12 | -0.403 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1hour, n=22,12,11,12,12 | -0.820 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5minutes, n=22,12,11,12,12 | -0.765 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7hours, n=22,12,11,12,12 | -0.366 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1.5hours, n=22,12,11,12,12 | -0.496 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9.5hours, n=22,12,11,12,12 | -0.485 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6.5hours, n=22,12,11,12,12 | -0.366 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2hours, n=22,12,11,12,12 | -0.215 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6hours, n=22,12,11,12,12 | -0.308 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2.5hours, n=21,12,11,12,12 | -0.120 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5.5hours, n=22,12,11,12,12 | -0.401 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5minutes, n=22,12,11,12,12 | -0.713 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10minutes, n=22,12,11,12,12 | -1.026 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-15minutes, n=22,12,10,12,12 | -1.039 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-20minutes, n=21,12,11,12,12 | -1.144 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-30minutes, n=22,12,11,12,12 | -1.143 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-45minutes, n=22,12,11,12,12 | -0.983 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1hour, n=22,12,11,12,12 | -0.882 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1.5hours, n=22,12,11,12,12 | -0.523 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2hours, n=22,12,11,12,12 | -0.459 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2.5hours, n=21,12,11,12,12 | -0.251 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3hours, n=22,12,11,12,12 | -0.172 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3.5hours, n=22,12,11,12,12 | -0.164 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4hours, n=22,12,11,12,12 | -0.201 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4.5hours, n=22,12,11,12,12 | -0.228 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5hours, n=22,12,11,12,12 | -0.246 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6hours, n=22,12,11,12,12 | -0.342 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6.5hours, n=22,12,11,12,12 | -0.393 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7hours, n=22,12,11,12,12 | -0.409 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7.5hours, n=22,12,11,12,12 | -0.442 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8hours, n=22,12,11,12,12 | -0.481 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8.5hours, n=22,12,11,12,12 | -0.446 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9hours, n=22,12,11,12,12 | -0.509 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9.5hours, n=22,12,11,12,12 | -0.473 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10hours, n=22,12,11,12,12 | -0.478 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10hours, n=22,12,11,12,12 | -0.206 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-30minutes, n=22,12,11,12,12 | -0.982 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6.5hours, n=22,12,11,12,12 | -0.245 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8hours, n=22,12,11,12,12 | -0.191 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2hours, n=22,12,11,12,12 | -0.195 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10minutes, n=22,12,11,12,12 | -0.833 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-20minutes, n=21,12,11,12,12 | -1.005 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5minutes, n=22,12,11,12,12 | -0.565 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8.5hours, n=22,12,11,12,12 | -0.158 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1hour, n=22,12,11,12,12 | -0.638 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9.5hours, n=22,12,11,12,12 | -0.246 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-15minutes, n=22,12,10,12,12 | -0.927 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7hours, n=22,12,11,12,12 | -0.202 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9hours, n=22,12,11,12,12 | -0.160 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6hours, n=22,12,11,12,12 | -0.231 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4hours, n=22,12,11,12,12 | -0.065 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2.5hours, n=21,12,11,12,12 | -0.138 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-45minutes, n=22,12,11,12,12 | -0.754 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4.5hours, n=22,12,11,12,12 | -0.137 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5.5hours, n=22,12,11,12,12 | -0.216 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3.5hours, n=22,12,11,12,12 | -0.111 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7.5hours, n=22,12,11,12,12 | -0.216 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1.5hours, n=22,12,11,12,12 | -0.337 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5hours, n=22,12,11,12,12 | -0.195 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3hours, n=22,12,11,12,12 | -0.086 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5hours, n=22,12,11,12,12 | -0.139 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2.5hours, n=21,12,11,12,12 | -0.107 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5.5hours, n=22,12,11,12,12 | -0.079 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-2hours, n=22,12,11,12,12 | -0.184 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6hours, n=22,12,11,12,12 | -0.152 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1.5hours, n=22,12,11,12,12 | -0.323 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-6.5hours, n=22,12,11,12,12 | -0.167 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-1hour, n=22,12,11,12,12 | -0.523 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7hours, n=22,12,11,12,12 | -0.222 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-45minutes, n=22,12,11,12,12 | -0.667 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9.5hours, n=22,12,11,12,12 | -0.139 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-7.5hours, n=22,12,11,12,12 | -0.163 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-30minutes, n=22,12,11,12,12 | -0.713 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-5minutes, n=22,12,11,12,12 | -0.437 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8hours, n=22,12,11,12,12 | -0.092 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-20minutes, n=21,12,11,12,12 | -0.666 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-8.5hours, n=22,12,11,12,12 | -0.075 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-15minutes, n=22,12,10,12,12 | -0.682 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10hours, n=22,12,11,12,12 | -0.133 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4hours, n=22,12,11,12,12 | -0.112 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3.5hours, n=22,12,11,12,12 | -0.093 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-9hours, n=22,12,11,12,12 | -0.093 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-4.5hours, n=22,12,11,12,12 | -0.091 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-3hours, n=22,12,11,12,12 | -0.158 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-allergen Challenge at Each Time Point | FEV1-10minutes, n=22,12,11,12,12 | -0.583 Liters |
95% CI: [-0.199, 0.24]
95% CI: [-0.096, 0.424]
95% CI: [-0.285, 0.333]
95% CI: [-0.229, 0.366]
95% CI: [-0.277, 0.254]
95% CI: [-0.269, 0.302]
95% CI: [-0.21, 0.301]
95% CI: [-0.178, 0.268]
95% CI: [-0.103, 0.295]
95% CI: [-0.121, 0.212]
95% CI: [-0.141, 0.196]
95% CI: [-0.138, 0.221]
95% CI: [-0.215, 0.162]
95% CI: [-0.076, 0.354]
95% CI: [-0.044, 0.342]
95% CI: [-0.119, 0.288]
95% CI: [-0.015, 0.438]
95% CI: [-0.051, 0.374]
95% CI: [-0.017, 0.461]
95% CI: [-0.089, 0.458]
95% CI: [0.007, 0.487]
95% CI: [-0.021, 0.509]
95% CI: [-0.086, 0.394]
95% CI: [-0.044, 0.394]
95% CI: [-0.122, 0.292]
95% CI: [-0.155, 0.3]
95% CI: [-0.213, 0.314]
95% CI: [-0.176, 0.461]
95% CI: [-0.208, 0.396]
95% CI: [-0.212, 0.327]
95% CI: [-0.224, 0.354]
95% CI: [-0.276, 0.243]
95% CI: [-0.209, 0.244]
95% CI: [-0.35, 0.053]
95% CI: [-0.253, 0.082]
95% CI: [-0.211, 0.13]
95% CI: [-0.161, 0.202]
95% CI: [-0.196, 0.186]
95% CI: [-0.105, 0.33]
95% CI: [-0.065, 0.326]
95% CI: [-0.213, 0.199]
95% CI: [-0.052, 0.407]
95% CI: [-0.08, 0.351]
95% CI: [-0.062, 0.421]
95% CI: [-0.131, 0.423]
95% CI: [-0.075, 0.411]
95% CI: [-0.047, 0.49]
95% CI: [-0.1, 0.387]
95% CI: [-0.035, 0.41]
95% CI: [-0.042, 0.378]
95% CI: [0.011, 0.431]
95% CI: [-0.006, 0.494]
95% CI: [-0.038, 0.548]
95% CI: [-0.057, 0.524]
95% CI: [-0.036, 0.474]
95% CI: [0.019, 0.568]
95% CI: [-0.019, 0.473]
95% CI: [-0.01, 0.418]
95% CI: [-0.075, 0.308]
95% CI: [-0.136, 0.19]
95% CI: [-0.116, 0.208]
95% CI: [-0.099, 0.247]
95% CI: [-0.051, 0.313]
95% CI: [-0.004, 0.411]
95% CI: [-0.004, 0.367]
95% CI: [-0.018, 0.373]
95% CI: [0.07, 0.506]
95% CI: [0.079, 0.488]
95% CI: [0.157, 0.616]
95% CI: [0.108, 0.636]
95% CI: [0.227, 0.688]
95% CI: [0.254, 0.765]
95% CI: [0.261, 0.723]
95% CI: [0.203, 0.625]
95% CI: [0.241, 0.639]
95% CI: [0.135, 0.562]
95% CI: [0.237, 0.751]
95% CI: [0.199, 0.8]
95% CI: [0.274, 0.872]
95% CI: [0.225, 0.751]
95% CI: [0.098, 0.663]
95% CI: [0.089, 0.596]
95% CI: [-0.003, 0.439]
95% CI: [-0.07, 0.323]
95% CI: [-0.107, 0.223]
95% CI: [-0.192, 0.139]
95% CI: [-0.085, 0.268]
95% CI: [-0.102, 0.269]
95% CI: [0.038, 0.461]
95% CI: [0.047, 0.429]
95% CI: [0.114, 0.516]
95% CI: [0.143, 0.591]
95% CI: [0.151, 0.571]
95% CI: [0.131, 0.602]
95% CI: [0.155, 0.694]
95% CI: [0.319, 0.793]
95% CI: [0.331, 0.854]
95% CI: [0.322, 0.797]
95% CI: [0.304, 0.739]
95% CI: [0.308, 0.719]
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 14,n=23,12,12,12,12 | -0.325 Liters |
| Placebo | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 13,n=24,12,12,12,12 | 0.027 Liters |
| Placebo | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 7,n=23,11,12,12,12 | -0.110 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 14,n=23,12,12,12,12 | -0.181 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 7,n=23,11,12,12,12 | 0.185 Liters |
| GW870086 0.25 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 13,n=24,12,12,12,12 | 0.212 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 14,n=23,12,12,12,12 | -0.199 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 13,n=24,12,12,12,12 | 0.108 Liters |
| GW870086 1 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 7,n=23,11,12,12,12 | 0.221 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 14,n=23,12,12,12,12 | 0.137 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 13,n=24,12,12,12,12 | 0.283 Liters |
| GW870086 3 mg OD | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 7,n=23,11,12,12,12 | 0.187 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 13,n=24,12,12,12,12 | 0.256 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 7,n=23,11,12,12,12 | 0.213 Liters |
| Fluticasone Propionate 0.25 mg BID | Change From Baseline in FEV1-non Allergen Challenge | FEV1,Day 14,n=23,12,12,12,12 | 0.047 Liters |
95% CI: [0.086, 0.503]
95% CI: [0.007, 0.363]
95% CI: [-0.062, 0.351]
95% CI: [0.133, 0.527]
95% CI: [-0.092, 0.253]
95% CI: [-0.076, 0.327]
95% CI: [0.1, 0.493]
95% CI: [0.083, 0.429]
95% CI: [0.262, 0.662]
95% CI: [0.125, 0.52]
95% CI: [0.057, 0.402]
95% CI: [0.172, 0.572]
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.
Time frame: 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.
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.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 52.91 Parts Per Billion |
| GW870086 0.25 mg OD | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 37.76 Parts Per Billion |
| GW870086 1 mg OD | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 34.95 Parts Per Billion |
| GW870086 3 mg OD | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 31.18 Parts Per Billion |
| Fluticasone Propionate 0.25 mg BID | Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period | 23.57 Parts Per Billion |
95% CI: [0.56, 0.9]
95% CI: [0.53, 0.82]
95% CI: [0.47, 0.74]
95% CI: [0.36, 0.55]
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Minimum FEV1 | -1.339 Liters |
| Placebo | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Weighted Mean FEV1 | -0.814 Liters |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Minimum FEV1 | -1.233 Liters |
| GW870086 1 mg OD | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Weighted Mean FEV1 | -0.789 Liters |
| GW870086 3 mg OD | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Weighted Mean FEV1 | -0.634 Liters |
| GW870086 3 mg OD | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Minimum FEV1 | -1.100 Liters |
| Fluticasone Propionate 0.25 mg BID | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Minimum FEV1 | -0.805 Liters |
| Fluticasone Propionate 0.25 mg BID | EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | Weighted Mean FEV1 | -0.464 Liters |
95% CI: [-0.302, 0.253]
95% CI: [-0.176, 0.387]
95% CI: [-0.028, 0.506]
95% CI: [0.26, 0.809]
95% CI: [-0.145, 0.253]
95% CI: [-0.176, 0.228]
95% CI: [-0.011, 0.371]
95% CI: [0.153, 0.548]
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).
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | -0.550 Liters |
| GW870086 0.25 mg OD | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | -0.340 Liters |
| GW870086 1 mg OD | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | -0.396 Liters |
| GW870086 3 mg OD | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | -0.248 Liters |
| Fluticasone Propionate 0.25 mg BID | LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period. | -0.146 Liters |
95% CI: [0.013, 0.407]
95% CI: [-0.046, 0.354]
95% CI: [0.113, 0.492]
95% CI: [0.209, 0.599]
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day1,pre-dose | 45.4 Grams per liter | Standard Deviation 2.41 |
| Placebo | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day14,pre-challenge | 69.3 Grams per liter | Standard Deviation 3.6 |
| Placebo | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day1,pre-dose | 70.6 Grams per liter | Standard Deviation 3.48 |
| Placebo | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day14,pre-challenge | 44.5 Grams per liter | Standard Deviation 2.47 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day14,pre-challenge | 44.5 Grams per liter | Standard Deviation 2.15 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day1,pre-dose | 45.5 Grams per liter | Standard Deviation 2.94 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day14,pre-challenge | 69.6 Grams per liter | Standard Deviation 3.2 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day1,pre-dose | 71.3 Grams per liter | Standard Deviation 3.96 |
| GW870086 1 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day14,pre-challenge | 67.8 Grams per liter | Standard Deviation 3.01 |
| GW870086 1 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day1,pre-dose | 45.2 Grams per liter | Standard Deviation 2.98 |
| GW870086 1 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day1,pre-dose | 68.8 Grams per liter | Standard Deviation 2.8 |
| GW870086 1 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day14,pre-challenge | 44.6 Grams per liter | Standard Deviation 2.43 |
| GW870086 3 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day1,pre-dose | 45.7 Grams per liter | Standard Deviation 2.23 |
| GW870086 3 mg OD | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day14,pre-challenge | 44.6 Grams per liter | Standard Deviation 1.73 |
| GW870086 3 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day14,pre-challenge | 68.2 Grams per liter | Standard Deviation 3.76 |
| GW870086 3 mg OD | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day1,pre-dose | 70.0 Grams per liter | Standard Deviation 3.1 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day14,pre-challenge | 69.6 Grams per liter | Standard Deviation 3.03 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Albumin and Total Protein | Total protein,Day1,pre-dose | 70.6 Grams per liter | Standard Deviation 2.81 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day1,pre-dose | 45.3 Grams per liter | Standard Deviation 3.42 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Albumin and Total Protein | Albumin,Day14,pre-challenge | 44.8 Grams per liter | Standard Deviation 2.25 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | 18.5 International unit per liter | Standard Deviation 4.74 |
| Placebo | 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 | 21.3 International unit per liter | Standard Deviation 6.01 |
| Placebo | 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 | 20.1 International unit per liter | Standard Deviation 4.48 |
| Placebo | 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 | 20.6 International unit per liter | Standard Deviation 7.41 |
| Placebo | 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 | 60.8 International unit per liter | Standard Deviation 15.08 |
| Placebo | 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 | 28.8 International unit per liter | Standard Deviation 17.64 |
| Placebo | 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 | 19.6 International unit per liter | Standard Deviation 6.28 |
| Placebo | 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 | 30.0 International unit per liter | Standard Deviation 22.3 |
| Placebo | 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 | 18.3 International unit per liter | Standard Deviation 7.83 |
| Placebo | 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 | 58.8 International unit per liter | Standard Deviation 14.52 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 4.5 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | 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 | 24.9 International unit per liter | Standard Deviation 6.95 |
| GW870086 1 mg OD | 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 | 57.3 International unit per liter | Standard Deviation 15.03 |
| GW870086 1 mg OD | 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 | 18.9 International unit per liter | Standard Deviation 5.37 |
| GW870086 1 mg OD | 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 | 19.5 International unit per liter | Standard Deviation 6.23 |
| GW870086 1 mg OD | 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 | 18.4 International unit per liter | Standard Deviation 4.1 |
| GW870086 1 mg OD | 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 | 19.4 International unit per liter | Standard Deviation 3.8 |
| GW870086 1 mg OD | 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 | 20.0 International unit per liter | Standard Deviation 3.69 |
| GW870086 1 mg OD | 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 | 19.3 International unit per liter | Standard Deviation 3.92 |
| GW870086 1 mg OD | 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 | 25.9 International unit per liter | Standard Deviation 7.69 |
| GW870086 1 mg OD | 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 | 55.6 International unit per liter | Standard Deviation 14.64 |
| GW870086 3 mg OD | 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 | 16.8 International unit per liter | Standard Deviation 8.16 |
| GW870086 3 mg OD | 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 | 17.6 International unit per liter | Standard Deviation 7.32 |
| GW870086 3 mg OD | 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 | 17.4 International unit per liter | Standard Deviation 6.88 |
| GW870086 3 mg OD | 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 | 17.8 International unit per liter | Standard Deviation 4.65 |
| GW870086 3 mg OD | 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 | 23.3 International unit per liter | Standard Deviation 15.77 |
| GW870086 3 mg OD | 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 | 53.3 International unit per liter | Standard Deviation 17.39 |
| GW870086 3 mg OD | 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 | 24.5 International unit per liter | Standard Deviation 18.25 |
| GW870086 3 mg OD | 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 | 19.3 International unit per liter | Standard Deviation 5.93 |
| GW870086 3 mg OD | 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 | 54.6 International unit per liter | Standard Deviation 18.08 |
| GW870086 3 mg OD | 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 | 18.7 International unit per liter | Standard Deviation 4.12 |
| Fluticasone Propionate 0.25 mg BID | 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 | 31.5 International unit per liter | Standard Deviation 19.76 |
| Fluticasone Propionate 0.25 mg BID | 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 | 20.3 International unit per liter | Standard Deviation 5.77 |
| Fluticasone Propionate 0.25 mg BID | 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 | 18.7 International unit per liter | Standard Deviation 4.16 |
| Fluticasone Propionate 0.25 mg BID | 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 | 21.1 International unit per liter | Standard Deviation 5.16 |
| Fluticasone Propionate 0.25 mg BID | 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 | 21.3 International unit per liter | Standard Deviation 5.9 |
| Fluticasone Propionate 0.25 mg BID | 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 | 20.3 International unit per liter | Standard Deviation 3.6 |
| Fluticasone Propionate 0.25 mg BID | 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 | 63.7 International unit per liter | Standard Deviation 9.7 |
| Fluticasone Propionate 0.25 mg BID | 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 | 64.1 International unit per liter | Standard Deviation 11.33 |
| Fluticasone Propionate 0.25 mg BID | 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 | 31.1 International unit per liter | Standard Deviation 19.78 |
| Fluticasone Propionate 0.25 mg BID | 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 | 23.8 International unit per liter | Standard Deviation 5.42 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day14,pre-challenge | 5.18 Millimoles per liter | Standard Deviation 0.832 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day1,pre-dose | 5.10 Millimoles per liter | Standard Deviation 0.443 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day14,pre-challenge | 104.7 Millimoles per liter | Standard Deviation 2.42 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day14,pre-challenge | 140.2 Millimoles per liter | Standard Deviation 1.93 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day1,pre-dose | 103.8 Millimoles per liter | Standard Deviation 1.84 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day14,pre-challenge | 2.355 Millimoles per liter | Standard Deviation 0.0896 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day1,pre-dose | 2.354 Millimoles per liter | Standard Deviation 0.0618 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day1,pre-dose | 139.8 Millimoles per liter | Standard Deviation 2.04 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day14,pre-challenge | 4.35 Millimoles per liter | Standard Deviation 0.32 |
| Placebo | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day1,pre-dose | 4.38 Millimoles per liter | Standard Deviation 0.304 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day14,pre-challenge | 139.3 Millimoles per liter | Standard Deviation 2.19 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day1,pre-dose | 2.377 Millimoles per liter | Standard Deviation 0.0873 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day14,pre-challenge | 2.343 Millimoles per liter | Standard Deviation 0.0568 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day14,pre-challenge | 104.5 Millimoles per liter | Standard Deviation 1.68 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day1,pre-dose | 5.04 Millimoles per liter | Standard Deviation 0.425 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day14,pre-challenge | 5.09 Millimoles per liter | Standard Deviation 0.429 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day1,pre-dose | 4.35 Millimoles per liter | Standard Deviation 0.224 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day14,pre-challenge | 4.27 Millimoles per liter | Standard Deviation 0.257 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day1,pre-dose | 139.2 Millimoles per liter | Standard Deviation 2.17 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day1,pre-dose | 103.7 Millimoles per liter | Standard Deviation 2.02 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day1,pre-dose | 2.338 Millimoles per liter | Standard Deviation 0.0591 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day1,pre-dose | 139.1 Millimoles per liter | Standard Deviation 1.38 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day14,pre-challenge | 5.23 Millimoles per liter | Standard Deviation 1.052 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day14,pre-challenge | 2.327 Millimoles per liter | Standard Deviation 0.0627 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day14,pre-challenge | 4.20 Millimoles per liter | Standard Deviation 0.338 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day1,pre-dose | 5.51 Millimoles per liter | Standard Deviation 0.95 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day14,pre-challenge | 104.6 Millimoles per liter | Standard Deviation 1.73 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day14,pre-challenge | 140.4 Millimoles per liter | Standard Deviation 1.24 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day1,pre-dose | 103.8 Millimoles per liter | Standard Deviation 2.59 |
| GW870086 1 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day1,pre-dose | 4.28 Millimoles per liter | Standard Deviation 0.205 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day14,pre-challenge | 4.36 Millimoles per liter | Standard Deviation 0.239 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day1,pre-dose | 104.0 Millimoles per liter | Standard Deviation 1.21 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day14,pre-challenge | 4.98 Millimoles per liter | Standard Deviation 0.283 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day1,pre-dose | 4.32 Millimoles per liter | Standard Deviation 0.279 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day14,pre-challenge | 2.324 Millimoles per liter | Standard Deviation 0.0562 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day1,pre-dose | 4.87 Millimoles per liter | Standard Deviation 0.375 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day1,pre-dose | 2.358 Millimoles per liter | Standard Deviation 0.0618 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day1,pre-dose | 139.7 Millimoles per liter | Standard Deviation 1.83 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day14,pre-challenge | 139.6 Millimoles per liter | Standard Deviation 1.51 |
| GW870086 3 mg OD | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day14,pre-challenge | 104.9 Millimoles per liter | Standard Deviation 2.39 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day1,pre-dose | 103.8 Millimoles per liter | Standard Deviation 2.05 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day14,pre-challenge | 2.334 Millimoles per liter | Standard Deviation 0.0566 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Calcium,Day1,pre-dose | 2.364 Millimoles per liter | Standard Deviation 0.071 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day14,pre-challenge | 140.3 Millimoles per liter | Standard Deviation 2.14 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day14,pre-challenge | 5.32 Millimoles per liter | Standard Deviation 0.949 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Glucose,Day1,pre-dose | 5.15 Millimoles per liter | Standard Deviation 0.768 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day14,pre-challenge | 4.31 Millimoles per liter | Standard Deviation 0.375 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Sodium,Day1,pre-dose | 139.4 Millimoles per liter | Standard Deviation 1.83 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Chloride,Day14,pre-challenge | 104.4 Millimoles per liter | Standard Deviation 1.62 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium | Potassium,Day1,pre-dose | 4.39 Millimoles per liter | Standard Deviation 0.25 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Hematocrit | Hematocrit,Day14,pre-challenge | 0.4383 Ratio | Standard Deviation 0.02929 |
| Placebo | Mean Laboratory Values for Hematocrit | Hematocrit,Day1,pre-dose | 0.4445 Ratio | Standard Deviation 0.02631 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day14,pre-challenge | 0.4476 Ratio | Standard Deviation 0.0307 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day1,pre-dose | 0.4519 Ratio | Standard Deviation 0.02474 |
| GW870086 1 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day14,pre-challenge | 0.4396 Ratio | Standard Deviation 0.0295 |
| GW870086 1 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day1,pre-dose | 0.4369 Ratio | Standard Deviation 0.0285 |
| GW870086 3 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day1,pre-dose | 0.4341 Ratio | Standard Deviation 0.01919 |
| GW870086 3 mg OD | Mean Laboratory Values for Hematocrit | Hematocrit,Day14,pre-challenge | 0.4225 Ratio | Standard Deviation 0.02418 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hematocrit | Hematocrit,Day14,pre-challenge | 0.4391 Ratio | Standard Deviation 0.0288 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hematocrit | Hematocrit,Day1,pre-dose | 0.4376 Ratio | Standard Deviation 0.02114 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day14,pre-challenge | 335.7 Grams per liter | Standard Deviation 4.97 |
| Placebo | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day1,pre-dose | 149.0 Grams per liter | Standard Deviation 9.04 |
| Placebo | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day1,pre-dose | 335.0 Grams per liter | Standard Deviation 5.43 |
| Placebo | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day14,pre-challenge | 147.1 Grams per liter | Standard Deviation 10.16 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day1,pre-dose | 335.9 Grams per liter | Standard Deviation 6.04 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day14,pre-challenge | 150.3 Grams per liter | Standard Deviation 10.23 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day1,pre-dose | 151.8 Grams per liter | Standard Deviation 7.58 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day14,pre-challenge | 335.8 Grams per liter | Standard Deviation 5.8 |
| GW870086 1 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day1,pre-dose | 336.3 Grams per liter | Standard Deviation 5.74 |
| GW870086 1 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day1,pre-dose | 147.1 Grams per liter | Standard Deviation 10.01 |
| GW870086 1 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day14,pre-challenge | 148.6 Grams per liter | Standard Deviation 9.79 |
| GW870086 1 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day14,pre-challenge | 337.9 Grams per liter | Standard Deviation 5.73 |
| GW870086 3 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day1,pre-dose | 145.2 Grams per liter | Standard Deviation 6.52 |
| GW870086 3 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day14,pre-challenge | 140.8 Grams per liter | Standard Deviation 9.11 |
| GW870086 3 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day14,pre-challenge | 333.5 Grams per liter | Standard Deviation 5.57 |
| GW870086 3 mg OD | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day1,pre-dose | 334.6 Grams per liter | Standard Deviation 7.24 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day14,pre-challenge | 335.7 Grams per liter | Standard Deviation 6.64 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day1,pre-dose | 147.2 Grams per liter | Standard Deviation 6.01 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin,Day14,pre-challenge | 147.4 Grams per liter | Standard Deviation 8.14 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC,Day1,pre-dose | 336.3 Grams per liter | Standard Deviation 4.23 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day1,pre-dose | 30.84 Picograms | Standard Deviation 1.473 |
| Placebo | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day14,pre-challenge | 30.87 Picograms | Standard Deviation 1.512 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day1,pre-dose | 31.23 Picograms | Standard Deviation 1.577 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day14,pre-challenge | 31.19 Picograms | Standard Deviation 1.576 |
| GW870086 1 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day1,pre-dose | 30.93 Picograms | Standard Deviation 1.652 |
| GW870086 1 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day14,pre-challenge | 30.92 Picograms | Standard Deviation 1.634 |
| GW870086 3 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day14,pre-challenge | 30.89 Picograms | Standard Deviation 0.961 |
| GW870086 3 mg OD | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day1,pre-dose | 30.86 Picograms | Standard Deviation 1.053 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day1,pre-dose | 30.58 Picograms | Standard Deviation 1.652 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH) | MCH,Day14,pre-challenge | 30.57 Picograms | Standard Deviation 1.629 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day1,pre-dose | 92.1 Femtoliters | Standard Deviation 4.87 |
| Placebo | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day14,pre-challenge | 92.0 Femtoliters | Standard Deviation 4.53 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day14,pre-challenge | 93.0 Femtoliters | Standard Deviation 3.84 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day1,pre-dose | 93.0 Femtoliters | Standard Deviation 4.43 |
| GW870086 1 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day14,pre-challenge | 91.5 Femtoliters | Standard Deviation 4.42 |
| GW870086 1 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day1,pre-dose | 92.0 Femtoliters | Standard Deviation 4.57 |
| GW870086 3 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day1,pre-dose | 92.3 Femtoliters | Standard Deviation 2.96 |
| GW870086 3 mg OD | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day14,pre-challenge | 92.8 Femtoliters | Standard Deviation 2.89 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day1,pre-dose | 91.0 Femtoliters | Standard Deviation 5.39 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Mean Corpuscle Volume (MCV) | MCV,Day14,pre-challenge | 91.2 Femtoliters | Standard Deviation 5.52 |
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).
Time frame: Up to Day 14 of each treatment period (approximately 17 weeks)
Population: All subject population. All participants were present at the time of assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day14,pre-challenge | 1.676 Giga cells per liter | Standard Deviation 0.4461 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day14,pre-challenge | 0.516 Giga cells per liter | Standard Deviation 0.2579 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day1,pre-dose | 0.027 Giga cells per liter | Standard Deviation 0.0123 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day1,pre-dose | 1.792 Giga cells per liter | Standard Deviation 0.5462 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day14,pre-challenge | 230.3 Giga cells per liter | Standard Deviation 31.03 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day14,pre-challenge | 0.021 Giga cells per liter | Standard Deviation 0.0118 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day14,pre-challenge | 6.15 Giga cells per liter | Standard Deviation 1.865 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day1,pre-dose | 233.9 Giga cells per liter | Standard Deviation 35.2 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day14,pre-challenge | 3.572 Giga cells per liter | Standard Deviation 1.4247 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day1,pre-dose | 3.258 Giga cells per liter | Standard Deviation 1.1745 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day1,pre-dose | 0.417 Giga cells per liter | Standard Deviation 0.2395 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day1,pre-dose | 5.88 Giga cells per liter | Standard Deviation 1.598 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day14,pre-challenge | 0.362 Giga cells per liter | Standard Deviation 0.0909 |
| Placebo | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day1,pre-dose | 0.384 Giga cells per liter | Standard Deviation 0.1283 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 0.11 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day14,pre-challenge | 1.771 Giga cells per liter | Standard Deviation 0.4827 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day1,pre-dose | 0.340 Giga cells per liter | Standard Deviation 0.1041 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day1,pre-dose | 0.429 Giga cells per liter | Standard Deviation 0.293 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day1,pre-dose | 0.022 Giga cells per liter | Standard Deviation 0.0094 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day14,pre-challenge | 0.382 Giga cells per liter | Standard Deviation 0.1712 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day1,pre-dose | 2.966 Giga cells per liter | Standard Deviation 1.1941 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day14,pre-challenge | 3.557 Giga cells per liter | Standard Deviation 1.3102 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day14,pre-challenge | 0.027 Giga cells per liter | Standard Deviation 0.0107 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day14,pre-challenge | 6.22 Giga cells per liter | Standard Deviation 1.681 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day1,pre-dose | 247.3 Giga cells per liter | Standard Deviation 47.1 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day14,pre-challenge | 230.4 Giga cells per liter | Standard Deviation 24.21 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day14,pre-challenge | 0.482 Giga cells per liter | Standard Deviation 0.2291 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day1,pre-dose | 5.86 Giga cells per liter | Standard Deviation 1.405 |
| GW870086 1 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day1,pre-dose | 2.100 Giga cells per liter | Standard Deviation 0.6834 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day1,pre-dose | 2.811 Giga cells per liter | Standard Deviation 0.4711 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day14,pre-challenge | 0.018 Giga cells per liter | Standard Deviation 0.0094 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day14,pre-challenge | 3.182 Giga cells per liter | Standard Deviation 0.7059 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day1,pre-dose | 5.15 Giga cells per liter | Standard Deviation 0.672 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day14,pre-challenge | 1.599 Giga cells per liter | Standard Deviation 0.5361 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day1,pre-dose | 1.688 Giga cells per liter | Standard Deviation 0.435 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day1,pre-dose | 229.6 Giga cells per liter | Standard Deviation 28.27 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day14,pre-challenge | 5.48 Giga cells per liter | Standard Deviation 1.008 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day14,pre-challenge | 229.0 Giga cells per liter | Standard Deviation 30.64 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day1,pre-dose | 0.308 Giga cells per liter | Standard Deviation 0.1579 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day1,pre-dose | 0.329 Giga cells per liter | Standard Deviation 0.0598 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day1,pre-dose | 0.016 Giga cells per liter | Standard Deviation 0.009 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day14,pre-challenge | 0.320 Giga cells per liter | Standard Deviation 0.1587 |
| GW870086 3 mg OD | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day14,pre-challenge | 0.355 Giga cells per liter | Standard Deviation 0.1313 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day14,pre-challenge | 5.64 Giga cells per liter | Standard Deviation 1.158 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day14,pre-challenge | 1.619 Giga cells per liter | Standard Deviation 0.3474 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day14,pre-challenge | 0.346 Giga cells per liter | Standard Deviation 0.2143 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Eosinophils,Day1,pre-dose | 0.459 Giga cells per liter | Standard Deviation 0.3528 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day14,pre-challenge | 0.023 Giga cells per liter | Standard Deviation 0.0089 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day14,pre-challenge | 3.288 Giga cells per liter | Standard Deviation 1.0353 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | WBC,Day1,pre-dose | 5.64 Giga cells per liter | Standard Deviation 1.439 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day14,pre-challenge | 220.8 Giga cells per liter | Standard Deviation 33.76 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Neutrophils,Day1,pre-dose | 3.251 Giga cells per liter | Standard Deviation 1.1947 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day1,pre-dose | 0.338 Giga cells per liter | Standard Deviation 0.1024 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Platelet,Day1,pre-dose | 238.8 Giga cells per liter | Standard Deviation 51.34 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Basophils,Day1,pre-dose | 0.021 Giga cells per liter | Standard Deviation 0.0079 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Monocytes,Day14,pre-challenge | 0.364 Giga cells per liter | Standard Deviation 0.1125 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Lymphocytes,Day1,pre-dose | 1.574 Giga cells per liter | Standard Deviation 0.3542 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day1,pre-dose | 0.04626 Trillion cells per liter | Standard Deviation 0.027363 |
| Placebo | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day14,pre-challenge | 0.04574 Trillion cells per liter | Standard Deviation 0.016707 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day14,pre-challenge | 0.05613 Trillion cells per liter | Standard Deviation 0.026415 |
| GW870086 0.25 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day1,pre-dose | 0.04708 Trillion cells per liter | Standard Deviation 0.026433 |
| GW870086 1 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day1,pre-dose | 0.04941 Trillion cells per liter | Standard Deviation 0.027213 |
| GW870086 1 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day14,pre-challenge | 0.04720 Trillion cells per liter | Standard Deviation 0.020698 |
| GW870086 3 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day1,pre-dose | 0.05176 Trillion cells per liter | Standard Deviation 0.016041 |
| GW870086 3 mg OD | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day14,pre-challenge | 0.04565 Trillion cells per liter | Standard Deviation 0.017335 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day14,pre-challenge | 0.05543 Trillion cells per liter | Standard Deviation 0.029142 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Reticulocytes | Reticulocytes,Day1,pre-dose | 0.05268 Trillion cells per liter | Standard Deviation 0.01756 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day1,pre-dose,n=24,12,12,12,12 | 90.7 Micromoles per liter | Standard Deviation 9.73 |
| Placebo | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day14,pre-challenge,n=24,12,12,12,12 | 87.3 Micromoles per liter | Standard Deviation 9.46 |
| Placebo | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day1,pre-dose,n=24,12,12,12,12 | 13.7 Micromoles per liter | Standard Deviation 7.06 |
| Placebo | 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 3.7 |
| Placebo | 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 1.44 |
| Placebo | 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 1.34 |
| Placebo | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day7,pre-dose,n=23,12,12,12,12 | 11.3 Micromoles per liter | Standard Deviation 5.18 |
| Placebo | 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 0.86 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day1,pre-dose,n=24,12,12,12,12 | 2.3 Micromoles per liter | Standard Deviation 0.97 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day1,pre-dose,n=24,12,12,12,12 | 12.6 Micromoles per liter | Standard Deviation 5.5 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day14,pre-challenge,n=24,12,12,12,12 | 84.3 Micromoles per liter | Standard Deviation 13.47 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day1,pre-dose,n=24,12,12,12,12 | 85.8 Micromoles per liter | Standard Deviation 10.38 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day7,pre-dose,n=23,12,12,12,12 | 11.8 Micromoles per liter | Standard Deviation 5.24 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day14,pre-challenge,n=24,12,12,12,12 | 12.7 Micromoles per liter | Standard Deviation 5.99 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day7,pre-dose,n=23,12,12,12,12 | 1.9 Micromoles per liter | Standard Deviation 0.9 |
| GW870086 1 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day14,pre-challenge,n=24,12,12,12,12 | 1.9 Micromoles per liter | Standard Deviation 1.16 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day1,pre-dose,n=24,12,12,12,12 | 11.8 Micromoles per liter | Standard Deviation 2.9 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day14,pre-challenge,n=24,12,12,12,12 | 89.6 Micromoles per liter | Standard Deviation 11.91 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day1,pre-dose,n=24,12,12,12,12 | 2.0 Micromoles per liter | Standard Deviation 0.74 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day7,pre-dose,n=23,12,12,12,12 | 10.3 Micromoles per liter | Standard Deviation 4.29 |
| GW870086 3 mg OD | 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 0.85 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day7,pre-dose,n=23,12,12,12,12 | 1.9 Micromoles per liter | Standard Deviation 1 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day1,pre-dose,n=24,12,12,12,12 | 89.3 Micromoles per liter | Standard Deviation 11.83 |
| GW870086 3 mg OD | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day14,pre-challenge,n=24,12,12,12,12 | 11.5 Micromoles per liter | Standard Deviation 4.54 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day14,pre-challenge,n=24,12,12,12,12 | 86.8 Micromoles per liter | Standard Deviation 10.06 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day1,pre-dose,n=24,12,12,12,12 | 14.7 Micromoles per liter | Standard Deviation 5.5 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day7,pre-dose,n=23,12,12,12,12 | 12.6 Micromoles per liter | Standard Deviation 5.43 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | TB,Day14,pre-challenge,n=24,12,12,12,12 | 11.7 Micromoles per liter | Standard Deviation 4.87 |
| Fluticasone Propionate 0.25 mg BID | 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 1.17 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day7,pre-dose,n=23,12,12,12,12 | 2.5 Micromoles per liter | Standard Deviation 1.09 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | DB,Day14,pre-challenge,n=24,12,12,12,12 | 2.3 Micromoles per liter | Standard Deviation 0.87 |
| Fluticasone Propionate 0.25 mg BID | Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine | Creatinine,Day1,pre-dose,n=24,12,12,12,12 | 86.5 Micromoles per liter | Standard Deviation 9.89 |
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Heart Rate | HR-Day 1, Pre dose, n=24,12,12,12,12 | 64.5 Beats per minute | Standard Deviation 8.15 |
| Placebo | Mean Values for Heart Rate | HR-Day 1, 1h Post dose, n=24,12,12,12,12 | 66.3 Beats per minute | Standard Deviation 8.87 |
| Placebo | Mean Values for Heart Rate | HR-Day 7, Post dose, n=23,11,12,12,12 | 63.3 Beats per minute | Standard Deviation 9.52 |
| Placebo | Mean Values for Heart Rate | HR-Day 13, Pre saline, n=24,12,12,12,12 | 62.5 Beats per minute | Standard Deviation 7.17 |
| Placebo | Mean Values for Heart Rate | HR-Day 14, Pre challenge, n=23,12,12,12,12 | 63.7 Beats per minute | Standard Deviation 7.83 |
| Placebo | Mean Values for Heart Rate | HR-Day 14, 1h Post challenge, n=21,11,11,12,12 | 67.9 Beats per minute | Standard Deviation 8.4 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | Mean Values for Heart Rate | HR-Day 14, 1h Post challenge, n=21,11,11,12,12 | 71.2 Beats per minute | Standard Deviation 8.3 |
| GW870086 0.25 mg OD | Mean Values for Heart Rate | HR-Day 1, Pre dose, n=24,12,12,12,12 | 61.7 Beats per minute | Standard Deviation 8.5 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | Mean Values for Heart Rate | HR-Day 13, Pre saline, n=24,12,12,12,12 | 62.3 Beats per minute | Standard Deviation 6.4 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 13, Pre saline, n=24,12,12,12,12 | 64.9 Beats per minute | Standard Deviation 7.96 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 14, Pre challenge, n=23,12,12,12,12 | 64.9 Beats per minute | Standard Deviation 5.12 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 1, Pre dose, n=24,12,12,12,12 | 62.8 Beats per minute | Standard Deviation 8.68 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 7, Post dose, n=23,11,12,12,12 | 64.0 Beats per minute | Standard Deviation 9.73 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 1, 1h Post dose, n=24,12,12,12,12 | 62.7 Beats per minute | Standard Deviation 9.33 |
| GW870086 1 mg OD | Mean Values for Heart Rate | HR-Day 14, 1h Post challenge, n=21,11,11,12,12 | 69.7 Beats per minute | Standard Deviation 8.22 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 13, Pre saline, n=24,12,12,12,12 | 62.3 Beats per minute | Standard Deviation 8.54 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 1, 1h Post dose, n=24,12,12,12,12 | 60.1 Beats per minute | Standard Deviation 6.71 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 7, Post dose, n=23,11,12,12,12 | 62.2 Beats per minute | Standard Deviation 7.88 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 14, 1h Post challenge, n=21,11,11,12,12 | 66.1 Beats per minute | Standard Deviation 8.94 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 14, Pre challenge, n=23,12,12,12,12 | 63.1 Beats per minute | Standard Deviation 9.76 |
| GW870086 3 mg OD | Mean Values for Heart Rate | HR-Day 1, Pre dose, n=24,12,12,12,12 | 60.5 Beats per minute | Standard Deviation 6.63 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 14, Pre challenge, n=23,12,12,12,12 | 62.1 Beats per minute | Standard Deviation 6.58 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 7, Post dose, n=23,11,12,12,12 | 63.7 Beats per minute | Standard Deviation 8.16 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 1, 1h Post dose, n=24,12,12,12,12 | 62.1 Beats per minute | Standard Deviation 6.69 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 14, 1h Post challenge, n=21,11,11,12,12 | 67.6 Beats per minute | Standard Deviation 5.6 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 13, Pre saline, n=24,12,12,12,12 | 64.0 Beats per minute | Standard Deviation 6.93 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Heart Rate | HR-Day 1, Pre dose, n=24,12,12,12,12 | 58.3 Beats per minute | Standard Deviation 6.37 |
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 123.8 Millimeters of mercury | Standard Deviation 10.34 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, Pre challenge, n=23,12,12,12,12 | 119.7 Millimeters of mercury | Standard Deviation 11.94 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, Pre dose, n=24,12,12,12,12 | 76.1 Millimeters of mercury | Standard Deviation 8.63 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 13, Pre saline, n=24,12,12,12,12 | 76.4 Millimeters of mercury | Standard Deviation 7.93 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 123.8 Millimeters of mercury | Standard Deviation 9.5 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, Pre challenge, n=23,12,12,12,12 | 75.6 Millimeters of mercury | Standard Deviation 8.04 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 7, Post dose, n=23,11,12,12,12 | 118.3 Millimeters of mercury | Standard Deviation 11.53 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 7, Post dose, n=23,11,12,12,12 | 74.0 Millimeters of mercury | Standard Deviation 7.91 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 73.8 Millimeters of mercury | Standard Deviation 7.42 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 13, Pre saline, n=24,12,12,12,12 | 121.9 Millimeters of mercury | Standard Deviation 9.21 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, Pre dose, n=24,12,12,12,12 | 120.8 Millimeters of mercury | Standard Deviation 12.11 |
| Placebo | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 74.3 Millimeters of mercury | Standard Deviation 5.59 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 10.3 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 0.25 mg OD | 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 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 13, Pre saline, n=24,12,12,12,12 | 118.8 Millimeters of mercury | Standard Deviation 9.26 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, Pre dose, n=24,12,12,12,12 | 74.7 Millimeters of mercury | Standard Deviation 6.75 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 72.1 Millimeters of mercury | Standard Deviation 5.84 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 7, Post dose, n=23,11,12,12,12 | 77.3 Millimeters of mercury | Standard Deviation 5.71 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 13, Pre saline, n=24,12,12,12,12 | 75.0 Millimeters of mercury | Standard Deviation 7.47 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, Pre challenge, n=23,12,12,12,12 | 77.0 Millimeters of mercury | Standard Deviation 5.01 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 73.5 Millimeters of mercury | Standard Deviation 6.53 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, Pre dose, n=24,12,12,12,12 | 121.3 Millimeters of mercury | Standard Deviation 6.53 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 121.5 Millimeters of mercury | Standard Deviation 6.75 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 7, Post dose, n=23,11,12,12,12 | 119.4 Millimeters of mercury | Standard Deviation 7.81 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, Pre challenge, n=23,12,12,12,12 | 124.5 Millimeters of mercury | Standard Deviation 10.08 |
| GW870086 1 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 123.7 Millimeters of mercury | Standard Deviation 7.81 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 118.6 Millimeters of mercury | Standard Deviation 9.26 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 71.3 Millimeters of mercury | Standard Deviation 7.32 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 7, Post dose, n=23,11,12,12,12 | 113.2 Millimeters of mercury | Standard Deviation 8.77 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, Pre challenge, n=23,12,12,12,12 | 76.0 Millimeters of mercury | Standard Deviation 8.8 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 13, Pre saline, n=24,12,12,12,12 | 74.2 Millimeters of mercury | Standard Deviation 7.36 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 13, Pre saline, n=24,12,12,12,12 | 120.0 Millimeters of mercury | Standard Deviation 11.8 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 7, Post dose, n=23,11,12,12,12 | 74.8 Millimeters of mercury | Standard Deviation 6.48 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, Pre challenge, n=23,12,12,12,12 | 116.8 Millimeters of mercury | Standard Deviation 9.69 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 74.5 Millimeters of mercury | Standard Deviation 4.81 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, Pre dose, n=24,12,12,12,12 | 76.6 Millimeters of mercury | Standard Deviation 6.58 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 117.1 Millimeters of mercury | Standard Deviation 8.8 |
| GW870086 3 mg OD | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, Pre dose, n=24,12,12,12,12 | 115.8 Millimeters of mercury | Standard Deviation 8.67 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 119.6 Millimeters of mercury | Standard Deviation 14.22 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 119.3 Millimeters of mercury | Standard Deviation 10.75 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, 1h Post dose, n=24,12,12,12,12 | 73.5 Millimeters of mercury | Standard Deviation 7.5 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, Pre challenge, n=23,12,12,12,12 | 74.8 Millimeters of mercury | Standard Deviation 6.36 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 13, Pre saline, n=24,12,12,12,12 | 73.5 Millimeters of mercury | Standard Deviation 7.74 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 1, Pre dose, n=24,12,12,12,12 | 73.7 Millimeters of mercury | Standard Deviation 6.27 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 7, Post dose, n=23,11,12,12,12 | 118.7 Millimeters of mercury | Standard Deviation 5.02 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 14, 1h Post challenge, n=21,11,11,12,12 | 72.9 Millimeters of mercury | Standard Deviation 7.33 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 14, Pre challenge, n=23,12,12,12,12 | 119.0 Millimeters of mercury | Standard Deviation 8.61 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP-Day 7, Post dose, n=23,11,12,12,12 | 73.8 Millimeters of mercury | Standard Deviation 7.31 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 1, Pre dose, n=24,12,12,12,12 | 117.1 Millimeters of mercury | Standard Deviation 7.54 |
| Fluticasone Propionate 0.25 mg BID | Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP-Day 13, Pre saline, n=24,12,12,12,12 | 119.2 Millimeters of mercury | Standard Deviation 11.92 |
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.
Time frame: Up to 17 weeks
Population: All subject population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | TEAE | 4 Participants |
| Placebo | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Placebo | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any AE | 8 Participants |
| GW870086 0.25 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any AE | 4 Participants |
| GW870086 0.25 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | TEAE | 3 Participants |
| GW870086 0.25 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GW870086 1 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any AE | 7 Participants |
| GW870086 1 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | TEAE | 5 Participants |
| GW870086 1 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | TEAE | 1 Participants |
| GW870086 3 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any AE | 4 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any AE | 3 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | TEAE | 2 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
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.
Time frame: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ANCS,n=24,12,12,12,12 | 5 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ANCS,n=21,11,11,12,12 | 2 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,Nr,n=24,12,12,12,12 | 20 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,Nr,n=23,12,12,12,12 | 16 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ACS,n=23,12,12,12,12 | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ACS,n=21,11,11,12,12 | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,Nr,n=21,11,11,12,12 | 19 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ACS,n=24,12,12,12,12 | 0 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ANCS,n=23,12,12,12,12 | 7 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,Nr,n=24,12,12,12,12 | 19 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ANCS,n=24,12,12,12,12 | 4 Participants |
| Placebo | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ACS,n=21,11,11,12,12 | 0 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ACS,n=23,12,12,12,12 | 0 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ANCS,n=24,12,12,12,12 | 3 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,Nr,n=24,12,12,12,12 | 10 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,Nr,n=24,12,12,12,12 | 9 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ANCS,n=21,11,11,12,12 | 1 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ANCS,n=24,12,12,12,12 | 2 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,Nr,n=21,11,11,12,12 | 10 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,Nr,n=23,12,12,12,12 | 7 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 0.25 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ANCS,n=23,12,12,12,12 | 5 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ANCS,n=21,11,11,12,12 | 1 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,Nr,n=24,12,12,12,12 | 10 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ANCS,n=24,12,12,12,12 | 2 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,Nr,n=23,12,12,12,12 | 8 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ANCS,n=23,12,12,12,12 | 4 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ACS,n=23,12,12,12,12 | 0 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,Nr,n=24,12,12,12,12 | 10 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ANCS,n=24,12,12,12,12 | 2 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,Nr,n=21,11,11,12,12 | 10 Participants |
| GW870086 1 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ACS,n=21,11,11,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ACS,n=23,12,12,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,Nr,n=24,12,12,12,12 | 11 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ANCS,n=24,12,12,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ANCS,n=23,12,12,12,12 | 1 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,Nr,n=23,12,12,12,12 | 11 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ACS,n=21,11,11,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,Nr,n=21,11,11,12,12 | 11 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ACS,n=24,12,12,12,12 | 0 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ANCS,n=24,12,12,12,12 | 1 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ANCS,n=21,11,11,12,12 | 1 Participants |
| GW870086 3 mg OD | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,Nr,n=24,12,12,12,12 | 12 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ACS,n=23,12,12,12,12 | 0 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,Nr,n=21,11,11,12,12 | 11 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,Nr,n=24,12,12,12,12 | 8 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ANCS,n=24,12,12,12,12 | 1 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ANCS,n=24,12,12,12,12 | 4 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,Nr,n=23,12,12,12,12 | 9 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ACS,n=21,11,11,12,12 | 0 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,1h Post dose,ANCS,n=23,12,12,12,12 | 3 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,ACS,n=24,12,12,12,12 | 0 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,Pre challenge,Nr,n=24,12,12,12,12 | 11 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D1,Pre dose,ACS,n=24,12,12,12,12 | 0 Participants |
| Fluticasone Propionate 0.25 mg BID | Number of Participants With Electrocardiogram (ECG) Findings | D14,1h Post challenge,ANCS,n=21,11,11,12,12 | 1 Participants |
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.
Time frame: 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.
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 0.27 milligrams per milliliter |
| GW870086 0.25 mg OD | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 0.22 milligrams per milliliter |
| GW870086 1 mg OD | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 0.33 milligrams per milliliter |
| GW870086 3 mg OD | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 0.66 milligrams per milliliter |
| Fluticasone Propionate 0.25 mg BID | Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period. | 0.95 milligrams per milliliter |
95% CI: [-1.3, 0.66]
95% CI: [-0.73, 1.28]
95% CI: [0.36, 2.19]
95% CI: [0.84, 2.75]