Trial Outcomes & Findings for 723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover (NCT NCT00972504)
NCT ID: NCT00972504
Last Updated: 2017-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Day 3 of each treatment period (approximately up to 63 days)
Results posted on
2017-08-02
Participant Flow
From June-2009 to August-2009, total of 54 participants were randomized at one site in Germany.
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.
Participant milestones
| Measure |
Overall Study
Participants randomized to receive once daily GSK1004723 (1000 micrograms \[µg\]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram \[mg\]) 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.
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|---|---|
|
Overall Study
STARTED
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54
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study
Participants randomized to receive once daily GSK1004723 (1000 micrograms \[µg\]) nasal spray solution for 3 days or oral tablet of GSK835726 (10 milligram \[mg\]) 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.
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Investigator discretion
|
1
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Baseline Characteristics
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Baseline characteristics by cohort
| Measure |
Overall Study
n=54 Participants
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.
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|---|---|
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Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=53 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=51 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
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|---|---|---|---|---|
|
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
Interval 4.4 to 5.4
|
4.2 Score on a scale
Interval 3.7 to 4.8
|
3.6 Score on a scale
Interval 3.1 to 4.1
|
3.5 Score on a scale
Interval 3.0 to 4.1
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=53 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=51 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
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
Interval 1.3 to 1.7
|
1.7 Score on a scale
Interval 1.5 to 1.8
|
1.3 Score on a scale
Interval 1.1 to 1.4
|
1.3 Score on a scale
Interval 1.1 to 1.4
|
|
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
Interval 1.3 to 1.7
|
1.3 Score on a scale
Interval 1.1 to 1.4
|
1.1 Score on a scale
Interval 0.9 to 1.3
|
1.0 Score on a scale
Interval 0.9 to 1.2
|
|
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
Interval 0.9 to 1.3
|
0.9 Score on a scale
Interval 0.7 to 1.0
|
0.8 Score on a scale
Interval 0.6 to 1.0
|
0.8 Score on a scale
Interval 0.6 to 1.0
|
|
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
Interval 0.7 to 0.9
|
0.4 Score on a scale
Interval 0.3 to 0.6
|
0.5 Score on a scale
Interval 0.4 to 0.6
|
0.5 Score on a scale
Interval 0.3 to 0.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=53 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=51 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
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
Interval 5.198 to 7.304
|
5.210 Grams
Interval 4.167 to 6.254
|
4.491 Grams
Interval 3.446 to 5.536
|
3.459 Grams
Interval 2.406 to 4.512
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=53 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=51 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
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
Interval 3.36 to 4.57
|
4.29 Score on a scale
Interval 3.69 to 4.89
|
2.92 Score on a scale
Interval 2.32 to 3.52
|
2.90 Score on a scale
Interval 2.29 to 3.51
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=54 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=52 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1-Pre challenge
|
3.908 Liters
Standard Deviation 0.7051
|
3.935 Liters
Standard Deviation 0.6515
|
3.924 Liters
Standard Deviation 0.7055
|
3.932 Liters
Standard Deviation 0.6654
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,1 hour
|
3.949 Liters
Standard Deviation 0.7319
|
3.959 Liters
Standard Deviation 0.6804
|
3.948 Liters
Standard Deviation 0.7125
|
3.958 Liters
Standard Deviation 0.6865
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,2 hour
|
3.910 Liters
Standard Deviation 0.7161
|
3.948 Liters
Standard Deviation 0.6444
|
3.936 Liters
Standard Deviation 0.7014
|
3.925 Liters
Standard Deviation 0.6829
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,3 hour
|
3.901 Liters
Standard Deviation 0.7134
|
3.938 Liters
Standard Deviation 0.6774
|
3.918 Liters
Standard Deviation 0.6941
|
3.899 Liters
Standard Deviation 0.7179
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,4 hour
|
3.881 Liters
Standard Deviation 0.7364
|
3.913 Liters
Standard Deviation 0.7083
|
3.903 Liters
Standard Deviation 0.7067
|
3.903 Liters
Standard Deviation 0.7124
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,5 hour
|
3.858 Liters
Standard Deviation 0.7314
|
3.890 Liters
Standard Deviation 0.6868
|
3.890 Liters
Standard Deviation 0.6954
|
3.858 Liters
Standard Deviation 0.7406
|
|
Mean Forced Expiratory Volume in 1 Second (FEV1)
FEV1,6 hour
|
3.914 Liters
Standard Deviation 0.7099
|
3.877 Liters
Standard Deviation 0.6381
|
3.887 Liters
Standard Deviation 0.6894
|
3.868 Liters
Standard Deviation 0.7231
|
SECONDARY outcome
Timeframe: approximately up to 63 daysPopulation: All Subjects population.
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any 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.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=54 Participants
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 Participants
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=52 Participants
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
15 Participants
|
53 Participants
|
13 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
GSK1004723 1000 µg Once Daily
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
GSK835726 10 mg Once Daily
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cetirizine 10 mg Once Daily
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=52 participants at risk
Participants randomized to this arm received placebo once daily for 3 days (to match GSK1004723, GSK835726 and cetirizine) 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.
|
GSK1004723 1000 µg Once Daily
n=54 participants at risk
Participants randomized to this arm received once daily GSK1004723 1000 µg nasal spray solution for 3 days, plus placebos to match both GSK835726 and cetirizine 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.
|
GSK835726 10 mg Once Daily
n=53 participants at risk
Participants randomized to this arm received once daily oral tablet of GSK835726 10 mg for 3 days, plus placebos to match both GSK1004723 and cetirizine 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.
|
Cetirizine 10 mg Once Daily
n=52 participants at risk
Participants randomized to this arm received once daily oral capsule of cetirizine 10 mg for 3 days, plus placebos to match both GSK1004723 and GSK835726 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.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
87.0%
47/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
7.4%
4/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.8%
2/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
7.4%
4/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
3.8%
2/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
3.8%
2/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
5.6%
3/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
5.6%
3/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Headache
|
15.4%
8/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
13.0%
7/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
11.3%
6/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
21.2%
11/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Migraine
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Nervous system disorders
Tremor
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
General disorders
Fatigue
|
3.8%
2/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
7.4%
4/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
5.7%
3/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
7.7%
4/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
General disorders
Pyrexia
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
9.3%
5/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Eye disorders
Eye irritation
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Infections and infestations
Herpes simplex
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
3.7%
2/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Vascular disorders
Hot flush
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Vascular disorders
Hypertension
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Investigations
Forced expiratory volume decreased
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/54 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
0.00%
0/53 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
1.9%
1/52 • AEs and SAEs were reported throughout the study (approximately up to 63 days).
All subject population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER