Rhinitis, Allergic, Seasonal
Conditions
Keywords
Proof of concept
Brief summary
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
Interventions
DRUGGSK835726 10mg
GSK835726 10mg tablet
DRUGGSK1004723 1000mcg
GSK1004723 1000mcg nasal spray solution
DRUGCetirizine 10mg
Cetirizine 10mg active comparator
DRUGplacebo
placebo to match actives
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. * Males or female using contraceptives * Aged 18 - 65 * Weight 50kg+, BMI 19-32 kg/m2 * Exhibit response to Challenge Chamber and skin prick test. * Non-smoker * Capable of giving informed consent * AST and ALT\<2xULN; alkaline phosphatase and bilirubin \<or=1.5xULN
Exclusion criteria
* No nasal structural abnornmality/polyposis, surgery, infection. * any respiratory disease, other than mild asthma or seasonal allergic rhinitis * participated in another clinical study within 30 days. * Subject has donated a unit of blood within 1 month * Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial. * History of sensitivty to drug * History of alcohol/drug abuse within 12 months. * Positive Hepatitis B antibody test * Positive HIV antibody test * Risk of non-compliance with study protocol * Pregnant or llactating females * Perenial allergic rhinitis * Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks. * Past or present disease that may affect outcome, as judge by investigator * Specific Immunotherapy within 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. |
| Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean. |
| Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean. |
| Mean Forced Expiratory Volume in 1 Second (FEV1) | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | approximately up to 63 days | 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 unfavorable 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 or is associated with liver injury and impaired liver function defined as: alanine aminotransferase \>=3 times upper limit of normal (ULN), and total bilirubin \>=2 times ULN or international normalized ratio more than 1.5. |
Countries
Germany
Participant flow
Recruitment details
From June-2009 to August-2009, total of 54 participants were randomized at one site in Germany.
Pre-assignment details
All participants had a diagnosis of seasonal allergic rhinitis and exhibited a moderate response to allergen challenge in the environmental challenge chamber (ECC) at Screening, defined as total nasal symptom score (TNSS) more than equal to (\>=) 6.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants randomized to receive once daily GSK1004723 1000 µg nasal spray solution for 3 days or oral tablet of GSK835726 10 mg or oral capsule of cetirizine 10 mg or matching placebo of these investigational products as per randomization schedule in the morning of each day. Each participant dosed at the same time each day relative to Day 1. Each treatment period was separated by at least 4 days washout period and there was at least 7 days between ECC days. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Investigator discretion | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 37.9 Years STANDARD_DEVIATION 10.92 |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 54 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 54 | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 15 / 52 | 53 / 54 | 13 / 53 | 17 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 54 | 0 / 53 | 0 / 52 |
Outcome results
Primary
Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.
Time frame: Day 3 of each treatment period (approximately up to 63 days)
Population: The all subjects population was used defined as all participants who receive 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 | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 4.9 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 4.2 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 3.6 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 3.5 Score on a scale |
95% CI: [-1.2, -0.1]
95% CI: [-1.8, -0.8]
95% CI: [-1.9, -0.8]
Secondary
Mean Forced Expiratory Volume in 1 Second (FEV1)
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes.
Time frame: Day 3 of each treatment period (approximately up to 63 days)
Population: All Subjects 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). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,2 hour | 3.910 Liters | Standard Deviation 0.7161 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,5 hour | 3.858 Liters | Standard Deviation 0.7314 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,6 hour | 3.914 Liters | Standard Deviation 0.7099 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,1 hour | 3.949 Liters | Standard Deviation 0.7319 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,3 hour | 3.901 Liters | Standard Deviation 0.7134 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,4 hour | 3.881 Liters | Standard Deviation 0.7364 |
| Placebo | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1-Pre challenge | 3.908 Liters | Standard Deviation 0.7051 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,6 hour | 3.877 Liters | Standard Deviation 0.6381 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,4 hour | 3.913 Liters | Standard Deviation 0.7083 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,5 hour | 3.890 Liters | Standard Deviation 0.6868 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1-Pre challenge | 3.935 Liters | Standard Deviation 0.6515 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,2 hour | 3.948 Liters | Standard Deviation 0.6444 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,3 hour | 3.938 Liters | Standard Deviation 0.6774 |
| GSK1004723 1000 µg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,1 hour | 3.959 Liters | Standard Deviation 0.6804 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,5 hour | 3.890 Liters | Standard Deviation 0.6954 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,6 hour | 3.887 Liters | Standard Deviation 0.6894 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1-Pre challenge | 3.924 Liters | Standard Deviation 0.7055 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,2 hour | 3.936 Liters | Standard Deviation 0.7014 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,3 hour | 3.918 Liters | Standard Deviation 0.6941 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,4 hour | 3.903 Liters | Standard Deviation 0.7067 |
| GSK835726 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,1 hour | 3.948 Liters | Standard Deviation 0.7125 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,4 hour | 3.903 Liters | Standard Deviation 0.7124 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1-Pre challenge | 3.932 Liters | Standard Deviation 0.6654 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,1 hour | 3.958 Liters | Standard Deviation 0.6865 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,2 hour | 3.925 Liters | Standard Deviation 0.6829 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,3 hour | 3.899 Liters | Standard Deviation 0.7179 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,5 hour | 3.858 Liters | Standard Deviation 0.7406 |
| Cetirizine 10 mg Once Daily | Mean Forced Expiratory Volume in 1 Second (FEV1) | FEV1,6 hour | 3.868 Liters | Standard Deviation 0.7231 |
Secondary
Number of Participants With Adverse Events (AE) 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 unfavorable 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 or is associated with liver injury and impaired liver function defined as: alanine aminotransferase \>=3 times upper limit of normal (ULN), and total bilirubin \>=2 times ULN or international normalized ratio more than 1.5.
Time frame: approximately up to 63 days
Population: All Subjects population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 15 Participants |
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK1004723 1000 µg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| GSK1004723 1000 µg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 53 Participants |
| GSK835726 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 13 Participants |
| GSK835726 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Cetirizine 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 17 Participants |
| Cetirizine 10 mg Once Daily | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
Secondary
Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean.
Time frame: Day 3 of each treatment period (approximately up to 63 days)
Population: All Subjects population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 3.97 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 4.29 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 2.92 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 2.90 Score on a scale |
95% CI: [-0.28, 0.93]
95% CI: [-1.65, -0.45]
95% CI: [-1.68, -0.46]
Secondary
Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.
Time frame: Day 3 of each treatment period (approximately up to 63 days)
Population: All Subjects population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Blockage | 1.5 Score on a scale |
| Placebo | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Rhinorrhoea | 1.5 Score on a scale |
| Placebo | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Itching | 1.1 Score on a scale |
| Placebo | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Sneezing | 0.8 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Sneezing | 0.4 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Itching | 0.9 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Rhinorrhoea | 1.3 Score on a scale |
| GSK1004723 1000 µg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Blockage | 1.7 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Itching | 0.8 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Rhinorrhoea | 1.1 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Sneezing | 0.5 Score on a scale |
| GSK835726 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Blockage | 1.3 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Blockage | 1.3 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Rhinorrhoea | 1.0 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Sneezing | 0.5 Score on a scale |
| Cetirizine 10 mg Once Daily | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Nasal Itching | 0.8 Score on a scale |
95% CI: [0, 0.3]
95% CI: [-0.4, -0.1]
95% CI: [-0.4, -0.1]
95% CI: [-0.4, -0.1]
95% CI: [-0.6, -0.2]
95% CI: [-0.6, -0.3]
95% CI: [-0.4, -0.1]
95% CI: [-0.5, -0.2]
95% CI: [-0.5, -0.2]
95% CI: [-0.5, -0.2]
95% CI: [-0.4, -0.2]
95% CI: [-0.5, -0.2]
Secondary
Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean.
Time frame: Day 3 of each treatment period (approximately up to 63 days)
Population: All Subjects population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 6.251 Grams |
| GSK1004723 1000 µg Once Daily | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 5.210 Grams |
| GSK835726 10 mg Once Daily | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 4.491 Grams |
| Cetirizine 10 mg Once Daily | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | 3.459 Grams |
95% CI: [-1.87, -0.212]
95% CI: [-2.584, -0.936]
95% CI: [-3.626, -1.957]