Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000115-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB-705498 | Experimental | Experimental |
|
| Fluticasone Propionate | Active Comparator | Active Comparator |
|
| Placebo | Placebo Comparator | Placebo Comparator |
|
| SB-705498+FP | Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-705498 | Drug | 12mg intranasal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 | Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC [tf-t1 hours]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS. | Day 8 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean TNSS and Its Individual Components From Day 4 to Day 8 | Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Mean of TNSS and its individual components is presented pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8. |
Not provided
Inclusion Criteria:
Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
TNSS score of >=4 following screening allergen challenge chamber.
Positive skin prick test for seasonal pollen
Positive RAST for seasonal pollen
Healthy as determined by responsible physician with the exception of mild asthma and AR
Male or female between 18 and 65 years of age inclusive.
A female subject is eligible to participate if she is of:
Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.
Body weight ≥ 50 kg (males) and ≥45kg (females) and BMI within the range 19 - 29.9 kg/m2 (inclusive).
Screening pre-challenge FEV1 greater than or equal to 80% and baselines FEV1/FVC greater than or equal to 70% of predicted value.
Capable of giving written informed consent.
Average QTcB, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
AST and ALT < 2xULN; alkaline phosphatase and bilirubin less than or equal to 1.5xULN
Exclusion Criteria:
Nasal abnormalities likely to affect the outcome of the study,
History of frequent nosebleeds.
Respiratory disease other than mild asthma
A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Positive pre-study drug/alcohol/smoking screen.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study defined as:
• An average weekly intake of >14 drinks for males or >7 drinks for females.
The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product prior to D1.
Exposure to more than four new chemical entities within 12 months prior to D1.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
History of sensitivity to any of the study medications, or components
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Lactating females.
Subject is mentally or legally incapacitated.
Urine cotinine levels indicative of smoking
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Vienna | A-1150 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23735181 | Background | Bareille P, Murdoch RD, Denyer J, Bentley J, Smart K, Yarnall K, Zieglmayer P, Zieglmayer R, Lemell P, Horak F. The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis. Int J Clin Pharmacol Ther. 2013 Jul;51(7):576-84. doi: 10.5414/CP201890. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111924 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
There were 3 study treatment periods each lasting 8 days separated by a washout of 14-20 days. Participants were randomized to 12 different sequences.
A total of 70 male and female participants with a history of allergic rhinitis (AR) were enrolled in this study. Study period was 14 April 2011 to 07 July 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A First, Then B, Then D | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG001 | Treatment B First, Then A, Then D | Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG002 | Treatment B, Then D, Then A | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods. |
| FG003 | Treatment A, Then D, Then B | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG004 | Treatment D, Then A, Then B | Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG005 | Treatment D, Then B, Then A | Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG006 | Treatment A, Then B, Then C | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG007 | Treatment B, Then A, Then C | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG008 | Treatment B, Then C, Then A | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG009 | Treatment A, Then C, Then B | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG010 | Treatment C, Then A, Then B | Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| FG011 | Treatment C, Then B, Then A | Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period-1 (8 Days) |
| |||||||||||||
| Washout Period-1 (14-20 Days) |
| |||||||||||||
| Period-2 (8 Days) |
| |||||||||||||
| Washout Period-2 (14-20 Days) |
| |||||||||||||
| Period-3 (8 Days) |
|
All subjects population comprised of all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A First, Then B, Then D | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered once-daily (OD) in morning for 8 days and 4 actuations per nostril of placebo matching Fluticasone propionate (FP) alone were administered OD in evening for 7 days). Participants received FP 200 microgram (μg) alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 milligrams (mg) SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 | Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC [tf-t1 hours]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS. | All subjects population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Score on scale | Day 8 of each treatment period |
Non-SAEs and SAEs were collected from start of the treatment up to Week 16.
All subject population was used for collection of adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C512301 | SB 705498 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FP |
| Drug |
200ug intranasal |
|
| placebo | Drug | placebo intranasal |
|
| pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8 of each treatment period |
| Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR) | Total Nasal Airflow is calculated as the sum of the left nostril and the right nostril airflow values. AAR is a very sensitive method of assessing clinical parameters of nasal obstruction (nasal flow, nasal resistance and nasal flow increase). A participant was instructed to breathe through one nostril while a sensor in the other nostril measured the difference in pre-nasal and choanal pressure. The system was connected to a computer. Nasal flow and nasal resistance were observed at pressure levels of 75, 150 and 300 Pascal. The defined measuring range for the flow was +-1000 milliliter per second (mL/s). Weighted means for total nasal airflow Resistance was calculated by dividing the area under the curve between 1 and 4 hours (via the linear trapezoidal method) by the total duration that the participant took to complete the chamber challenge assessments. | Day 8 |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo | The RQLQ composed of 28 items covering 7 domains of health. Each question is scored on a scale of 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). 7 domains were: Activities (3 items):1, 2, 3;Sleep (3 items): 4, 5, 6; Non-nose/eye symptoms (7 items): 7, 8, 9, 10, 11, 12, 13; Practical Problems (3 items): 14, 15, 16; Nasal Symptoms (4 items): 17, 18, 19, 20; Eye Symptoms (4 items): 21, 22, 23, 24; Emotional (4 items): 25, 26, 27, 28 consisted of total 28 items. Domain activity score = total post-baseline score for individualized activity items answered on both visits divided by total Baseline score for individualized activity items answered on both visits multiplied by the Baseline score for item(s) missing post-baseline. The global RQLQ score was calculated by averaging all 28 item scores, which ranges from 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). Higher scores indicate worsening of symptoms. | Day 8 |
| Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8 | Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV. | Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h) |
| Maximum Observed Concentration (Cmax) for SB-705498 on Day 8 | Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as least squares geometric means with respective geometric coefficient of variation (% CV). | Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h) |
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) | Vital signs assessment included heart rate, blood pressure, and temperature. Criteria for vital sign values meeting potential clinical concern included: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mm Hg), diastolic blood pressure (DBP) < 45 and > 100 mm Hg, temperature <36 and >37.5 Degree Celsius and heart Rate <40 and >110 beats per minute. Only parameters with PCI values are reported. | Up to Week 16 |
| Change From Baseline in ECG Values: Heart Rate | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, and QTc intervals. Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. | Baseline and Day 8 of each treatment period |
| Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, QTc corrected by Bazett's formula (QTcB) and QTc corrected by Fridericia's formula (QTcF). Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. | Baseline and Day 8 of each treatment period |
| Number of Participants With Hematology Parameters of PCI | The PCC range for hematology parameters included white blood cell count, low: 0.67, high 1.82, neutrophil count, low: 0.83, Hemoglobin, male- high 1.03, female- high 1.13, hematocrit, male- high 1.02, female- high 1.17, Platelet Count, low: 0.67, high: 1.57, lymphocytes, low 0.81. Only parameters with PCI values are reported. | Up to Week 16 |
| Number of Participants With Clinical Biochemistry Parameters of PCI | The PCC range for clinical chemistry parameters included albumin, low: 0.86, millimole per liter (mmol)/L, calcium, low: 0.91, high: 1.06, glucose. Low: 0.71, high: 1.41, Potassium, low: 0.86, high: 1.10, Sodium, low: 0.96, high: 1.03, Total CO2, Low: 0.86, high: 1.14, Creatinine, in male, Low: <75 micromole per liter (μmol/L), high: >110 μmol/L, female, Low: <65 μmol/L, high: >95, Blood Urea Nitrogen (BUN), high: >1.5xULN mmol/L, Uric Acid, in male, Low: < 180 μmol/L, high: > 480 μmol/L, female, Low: < 120 μmol/L, high: > 420. Only parameters with PCI values are reported. | Up to Week 16 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111924 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment B First, Then A, Then D | Eligible participants received Participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG002 | Treatment B, Then D, Then A | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days).There was a 14-20 days washout between 2 treatment periods. |
| BG003 | Treatment A, Then D, Then B | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG004 | Treatment D, Then A, Then B | Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG005 | Treatment D, Then B, Then A | Eligible participants received 12 mg SB-705498 co-administered with FP (Treatment D) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG006 | Treatment A, Then B, Then C | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG007 | Treatment B, Then A, Then C | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-3 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG008 | Treatment B, Then C, Then A | Eligible participants received FP 200 μg alone (Treatment B) in Period-1 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG009 | Treatment A, Then C, Then B | Eligible participants received Placebo alone (treatment A) in period-1 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received SB-705498 12 mg alone (Treatment C) in Period-2 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG010 | Treatment C, Then A, Then B | Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-2 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-3 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG011 | Treatment C, Then B, Then A | Eligible participants received SB-705498 12 mg alone (Treatment C) in Period-1 (4 actuations per nostril [each of 1.5mg] of 12 mg SB-705498 were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). Participants received FP 200 μg alone (Treatment B) in Period-2 (4 actuations per nostril of Placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril [each of 25μg] of FP 200 μg alone were administered OD in evening for 7 days). Participants received Placebo alone (treatment A) in period-3 (4 actuations per nostril of placebo matching SB-705498 alone were administered OD in morning for 8 days and 4 actuations per nostril of placebo matching FP alone were administered OD in evening for 7 days). There was a 14-20 days washout between 2 treatment periods. |
| BG012 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. |
| OG001 | FP 200 μg | Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation. |
| OG002 | SB-705498 12 mg | Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. |
| OG003 | SB-705498 + FP 12 mg | Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. |
|
|
|
| Secondary | Mean TNSS and Its Individual Components From Day 4 to Day 8 | Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Mean of TNSS and its individual components is presented pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8 of each treatment period |
|
|
|
| Secondary | Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR) | Total Nasal Airflow is calculated as the sum of the left nostril and the right nostril airflow values. AAR is a very sensitive method of assessing clinical parameters of nasal obstruction (nasal flow, nasal resistance and nasal flow increase). A participant was instructed to breathe through one nostril while a sensor in the other nostril measured the difference in pre-nasal and choanal pressure. The system was connected to a computer. Nasal flow and nasal resistance were observed at pressure levels of 75, 150 and 300 Pascal. The defined measuring range for the flow was +-1000 milliliter per second (mL/s). Weighted means for total nasal airflow Resistance was calculated by dividing the area under the curve between 1 and 4 hours (via the linear trapezoidal method) by the total duration that the participant took to complete the chamber challenge assessments. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Milliliters per second (mL/s) | Day 8 |
|
|
|
|
| Secondary | Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo | The RQLQ composed of 28 items covering 7 domains of health. Each question is scored on a scale of 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). 7 domains were: Activities (3 items):1, 2, 3;Sleep (3 items): 4, 5, 6; Non-nose/eye symptoms (7 items): 7, 8, 9, 10, 11, 12, 13; Practical Problems (3 items): 14, 15, 16; Nasal Symptoms (4 items): 17, 18, 19, 20; Eye Symptoms (4 items): 21, 22, 23, 24; Emotional (4 items): 25, 26, 27, 28 consisted of total 28 items. Domain activity score = total post-baseline score for individualized activity items answered on both visits divided by total Baseline score for individualized activity items answered on both visits multiplied by the Baseline score for item(s) missing post-baseline. The global RQLQ score was calculated by averaging all 28 item scores, which ranges from 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). Higher scores indicate worsening of symptoms. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Score on a scale | Day 8 |
|
|
|
|
| Secondary | Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8 | Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV. | The 'Pharmacokinetic Population' is defined as participants in the 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per mililiter (ng.h/mL) | Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h) |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) for SB-705498 on Day 8 | Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as least squares geometric means with respective geometric coefficient of variation (% CV). | Pharmacokinetic Population. Only those participants available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per mililiter (ng/mL) | Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h) |
|
|
|
| Secondary | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) | Vital signs assessment included heart rate, blood pressure, and temperature. Criteria for vital sign values meeting potential clinical concern included: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mm Hg), diastolic blood pressure (DBP) < 45 and > 100 mm Hg, temperature <36 and >37.5 Degree Celsius and heart Rate <40 and >110 beats per minute. Only parameters with PCI values are reported. | All Subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 16 |
|
|
|
| Secondary | Change From Baseline in ECG Values: Heart Rate | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, and QTc intervals. Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline and Day 8 of each treatment period |
|
|
|
| Secondary | Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, QTc corrected by Bazett's formula (QTcB) and QTc corrected by Fridericia's formula (QTcF). Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds (msec) | Baseline and Day 8 of each treatment period |
|
|
|
| Secondary | Number of Participants With Hematology Parameters of PCI | The PCC range for hematology parameters included white blood cell count, low: 0.67, high 1.82, neutrophil count, low: 0.83, Hemoglobin, male- high 1.03, female- high 1.13, hematocrit, male- high 1.02, female- high 1.17, Platelet Count, low: 0.67, high: 1.57, lymphocytes, low 0.81. Only parameters with PCI values are reported. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 16 |
|
|
|
| Secondary | Number of Participants With Clinical Biochemistry Parameters of PCI | The PCC range for clinical chemistry parameters included albumin, low: 0.86, millimole per liter (mmol)/L, calcium, low: 0.91, high: 1.06, glucose. Low: 0.71, high: 1.41, Potassium, low: 0.86, high: 1.10, Sodium, low: 0.96, high: 1.03, Total CO2, Low: 0.86, high: 1.14, Creatinine, in male, Low: <75 micromole per liter (μmol/L), high: >110 μmol/L, female, Low: <65 μmol/L, high: >95, Blood Urea Nitrogen (BUN), high: >1.5xULN mmol/L, Uric Acid, in male, Low: < 180 μmol/L, high: > 480 μmol/L, female, Low: < 120 μmol/L, high: > 420. Only parameters with PCI values are reported. | All subjects population. Only those participants available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 16 |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 24 |
| 68 |
| EG001 | FP 200 μg | Participants administered matching placebo for SB-705498 once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. Each spray of FP delivered approximately 25μg per actuation. | 0 | 69 | 0 | 69 | 28 | 69 |
| EG002 | SB-705498 12 mg | Participants administered SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and matching placebo for FP once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. | 0 | 23 | 0 | 23 | 13 | 23 |
| EG003 | SB-705498 + FP 12 mg | Participants received SB-705498 12 mg once-daily in the form of Intranasal suspension four actuations in each nostril for 8 days in morning using Device A and FP 200 μg once-daily in the form of Intranasal spray four actuations in each nostril in evening for 7 days using Device B. | 0 | 47 | 0 | 47 | 19 | 47 |
| Food allergy | Immune system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D010038 |
| Otorhinolaryngologic Diseases |
|
| TNSS,Day 5, pre-pm dose |
|
|
| TNSS,Day 6, pre-pm dose |
|
|
| TNSS,Day 7, pre-pm dose |
|
|
| TNSS,Day 8, pre-challenge (1hr) |
|
|
| Nasal congestion score code,Day 4, pre-pm dose |
|
|
| Nasal congestion score code,Day 5, pre-pm dose |
|
|
| Nasal congestion score code,Day 6, pre-pm dose |
|
|
| Nasal congestion score code,Day 7, pre-pm dose |
|
|
| Nasal congestion score code,Day 8, pre-challenge |
|
|
| Rhinorrhoea score code,Day 4, pre-pm dose |
|
|
| Rhinorrhoea score code,Day 5, pre-pm dose |
|
|
| Rhinorrhoea score code,Day 6, pre-pm dose |
|
|
| Rhinorrhoea score code,Day 7, pre-pm dose |
|
|
| Rhinorrhoea score code,Day 8, pre-challenge (1hr) |
|
|
| Nasal itching score code,Day 4, pre-pm dose |
|
|
| Nasal itching score code,Day 5, pre-pm dose |
|
|
| Nasal itching score code,Day 6, pre-pm dose |
|
|
| Nasal itching score code,Day 7, pre-pm dose |
|
|
| Nasal itching score code,Day 8, pre-challenge (1hr |
|
|
| Sneezing score code,Day 4, pre-pm dose |
|
|
| Sneezing score code,Day 5, pre-pm dose |
|
|
| Sneezing score code,Day 6, pre-pm dose |
|
|
| Sneezing score code,Day 7, pre-pm dose |
|
|
| Sneezing score code,Day 8, pre-challenge (1hr) |
|
|
| Mean Difference (Net) |
| -7.31 |
| Standard Error of the Mean |
| 19.548 |
| 2-Sided |
| 90 |
| -39.7 |
| 25.05 |
| Superiority or Other |
| Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr | Mean Difference (Net) | 72.40 | Standard Error of the Mean | 14.567 | 2-Sided | 90 | 48.28 | 96.52 | Superiority or Other |
| FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr | Mean Difference (Net) | -8.95 | Standard Error of the Mean | 14.592 | 2-Sided | 90 | -33.1 | 15.22 | Superiority or Other |
| Mean Difference (Net) |
| -0.01 |
| Standard Error of the Mean |
| 0.173 |
| 2-Sided |
| 90 |
| -0.30 |
| 0.27 |
| Superiority or Other |
| Mean Difference (Net) | -0.52 | Standard Error of the Mean | 0.130 | 2-Sided | 90 | -0.74 | -0.31 | Superiority or Other |
| Mean Difference (Net) | 0.15 | Standard Error of the Mean | 0.130 | 2-Sided | 90 | -0.06 | 0.37 | Superiority or Other |
| Temperature,Low,Follow up |
|
| QRS Duration |
|
| QT Interval |
|
| QTcB |
|
| QTcF |
|
| Hematocrit,high |
|
| Hemoglobin,high |
|
| Creatinine,High |
|
| Aspartate Amino Transferase,High |
|
| Potassium,High |
|
| Uric acid,High |
|
| Gamma Glutamyl Transferase,High |
|
| Total Bilirubin,High |
|
| Alanine Amino Transferase,High |
|