Trial Outcomes & Findings for A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen (NCT NCT00291642)

NCT ID: NCT00291642

Last Updated: 2018-09-11

Results Overview

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 551 participants
• Primary outcome timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
• Results posted on: 2018-09-11

Participant Flow

Participant Flow refers to the Randomized Set.

Participant milestones

Measure	Placebo (PBO) A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Study STARTED	78	116	119	119	119
Overall Study COMPLETED	76	116	117	119	118
Overall Study NOT COMPLETED	2	0	2	0	1

Reasons for withdrawal

Measure	Placebo (PBO) A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Study Adverse Event	1	0	1	0	1
Overall Study Patient missed visit	0	0	1	0	0
Overall Study Intake of prohibited medication	1	0	0	0	0

Baseline Characteristics

A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

Baseline characteristics by cohort

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.	Total Title n=551 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	15 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	113 Participants n=7 Participants	114 Participants n=5 Participants	113 Participants n=4 Participants	114 Participants n=21 Participants	530 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=8 Participants
Age, Continuous	33.71 years STANDARD_DEVIATION 12.46 • n=5 Participants	33.45 years STANDARD_DEVIATION 11.28 • n=7 Participants	34.36 years STANDARD_DEVIATION 12.84 • n=5 Participants	32.91 years STANDARD_DEVIATION 11.30 • n=4 Participants	34.33 years STANDARD_DEVIATION 11.65 • n=21 Participants	33.76 years STANDARD_DEVIATION 11.86 • n=8 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	65 Participants n=7 Participants	68 Participants n=5 Participants	65 Participants n=4 Participants	72 Participants n=21 Participants	312 Participants n=8 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants	54 Participants n=4 Participants	47 Participants n=21 Participants	239 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Population: Only patients with valid MSC scores in Period I were included in the analysis.

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I	-3.80 units on a scale Standard Error 0.495	-7.15 units on a scale Standard Error 0.406	-7.05 units on a scale Standard Error 0.401	-7.93 units on a scale Standard Error 0.401	-7.54 units on a scale Standard Error 0.401

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]

Population: Only patients with valid MSC scores in Period II were included in the analysis.

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=76 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=117 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=118 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the MSC Score Over Period II	-3.50 units on a scale Standard Error 0.604	-6.35 units on a scale Standard Error 0.489	-7.07 units on a scale Standard Error 0.487	-6.78 units on a scale Standard Error 0.483	-7.92 units on a scale Standard Error 0.485

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid MSC scores in Period I and II were included in the analysis.

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)	-3.61 units on a scale Standard Error 0.473	-6.80 units on a scale Standard Error 0.388	-7.10 units on a scale Standard Error 0.383	-7.43 units on a scale Standard Error 0.384	-7.72 units on a scale Standard Error 0.383

SECONDARY outcome

Timeframe: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Population: Only patients with valid TSC scores in Period I were included in the analysis.

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I	-6.55 units on a scale Standard Error 0.757	-11.33 units on a scale Standard Error 0.620	-11.27 units on a scale Standard Error 0.613	-12.71 units on a scale Standard Error 0.613	-11.74 units on a scale Standard Error 0.613

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]

Population: Only patients with valid TSC scores in Period II were included in the analysis.

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=76 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=117 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=118 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II	-5.73 units on a scale Standard Error 0.917	-10.25 units on a scale Standard Error 0.742	-11.03 units on a scale Standard Error 0.739	-10.73 units on a scale Standard Error 0.734	-12.14 units on a scale Standard Error 0.736

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid TSC scores in Period I and II were included in the analysis.

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)	-6.10 units on a scale Standard Error 0.729	-10.86 units on a scale Standard Error 0.598	-11.22 units on a scale Standard Error 0.591	-11.84 units on a scale Standard Error 0.591	-11.92 units on a scale Standard Error 0.591

SECONDARY outcome

Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Population: Only subjects with valid individual symptom scores in Period I were included in the analysis.

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Individual Symptom Scores Over Period I Runny Nose Score	-0.60 units on a scale Standard Error 0.095	-1.01 units on a scale Standard Error 0.078	-0.95 units on a scale Standard Error 0.077	-1.17 units on a scale Standard Error 0.077	-1.04 units on a scale Standard Error 0.077
Change From Baseline in the Individual Symptom Scores Over Period I Itchy Nose Score	-0.66 units on a scale Standard Error 0.099	-1.03 units on a scale Standard Error 0.082	-1.09 units on a scale Standard Error 0.081	-1.28 units on a scale Standard Error 0.081	-1.10 units on a scale Standard Error 0.081
Change From Baseline in the Individual Symptom Scores Over Period I Sniffles Score	-0.65 units on a scale Standard Error 0.100	-1.15 units on a scale Standard Error 0.082	-1.06 units on a scale Standard Error 0.081	-1.24 units on a scale Standard Error 0.081	-1.10 units on a scale Standard Error 0.081
Change From Baseline in the Individual Symptom Scores Over Period I Nose Blow Score	-0.98 units on a scale Standard Error 0.129	-1.87 units on a scale Standard Error 0.106	-1.82 units on a scale Standard Error 0.105	-1.92 units on a scale Standard Error 0.105	-1.96 units on a scale Standard Error 0.105
Change From Baseline in the Individual Symptom Scores Over Period I Sneezes Score	-0.37 units on a scale Standard Error 0.103	-1.15 units on a scale Standard Error 0.084	-1.07 units on a scale Standard Error 0.083	-1.22 units on a scale Standard Error 0.083	-1.23 units on a scale Standard Error 0.083
Change From Baseline in the Individual Symptom Scores Over Period I Watery Eyes Score	-0.56 units on a scale Standard Error 0.090	-0.94 units on a scale Standard Error 0.074	-1.08 units on a scale Standard Error 0.073	-1.13 units on a scale Standard Error 0.073	-1.07 units on a scale Standard Error 0.073

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]

Population: Only subjects with valid individual symptom scores in Period II were included in the analysis.

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=76 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=117 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=118 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Individual Symptom Scores Over Period II Runny Nose Score	-0.62 units on a scale Standard Error 0.122	-0.86 units on a scale Standard Error 0.098	-0.94 units on a scale Standard Error 0.098	-0.95 units on a scale Standard Error 0.097	-1.10 units on a scale Standard Error 0.098
Change From Baseline in the Individual Symptom Scores Over Period II Itchy Nose Score	-0.57 units on a scale Standard Error 0.120	-1.00 units on a scale Standard Error 0.097	-1.11 units on a scale Standard Error 0.097	-1.13 units on a scale Standard Error 0.096	-1.24 units on a scale Standard Error 0.096
Change From Baseline in the Individual Symptom Scores Over Period II Sniffles Score	-0.58 units on a scale Standard Error 0.127	-0.91 units on a scale Standard Error 0.103	-0.96 units on a scale Standard Error 0.102	-0.90 units on a scale Standard Error 0.101	-1.21 units on a scale Standard Error 0.102
Change From Baseline in the Individual Symptom Scores Over Period II Nose Blow Score	-1.00 units on a scale Standard Error 0.162	-1.61 units on a scale Standard Error 0.131	-1.84 units on a scale Standard Error 0.131	-1.78 units on a scale Standard Error 0.130	-2.02 units on a scale Standard Error 0.130
Change From Baseline in the Individual Symptom Scores Over Period II Sneezes Score	-0.48 units on a scale Standard Error 0.112	-1.18 units on a scale Standard Error 0.091	-1.33 units on a scale Standard Error 0.090	-1.19 units on a scale Standard Error 0.089	-1.38 units on a scale Standard Error 0.090
Change From Baseline in the Individual Symptom Scores Over Period II Watery Eyes Score	-0.30 units on a scale Standard Error 0.119	-0.78 units on a scale Standard Error 0.097	-0.91 units on a scale Standard Error 0.096	-0.83 units on a scale Standard Error 0.096	-0.93 units on a scale Standard Error 0.096

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only subjects with valid individual symptom scores in Period I and II were included in the analysis.

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Measure	Placebo (PBO) n=78 Participants A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 Participants A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 Participants A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 Participants A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 Participants A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Runny Nose Score	-0.59 units on a scale Standard Error 0.093	-0.94 units on a scale Standard Error 0.076	-0.95 units on a scale Standard Error 0.075	-1.07 units on a scale Standard Error 0.075	-1.06 units on a scale Standard Error 0.075
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Itchy Nose Score	-0.61 units on a scale Standard Error 0.097	-1.02 units on a scale Standard Error 0.080	-1.10 units on a scale Standard Error 0.079	-1.21 units on a scale Standard Error 0.079	-1.16 units on a scale Standard Error 0.079
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Sniffles Score	-0.60 units on a scale Standard Error 0.098	-1.05 units on a scale Standard Error 0.080	-1.02 units on a scale Standard Error 0.079	-1.09 units on a scale Standard Error 0.079	-1.15 units on a scale Standard Error 0.079
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Nose Blow Score	-0.98 units on a scale Standard Error 0.124	-1.75 units on a scale Standard Error 0.102	-1.83 units on a scale Standard Error 0.100	-1.86 units on a scale Standard Error 0.101	-1.99 units on a scale Standard Error 0.100
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Sneezes Score	-0.41 units on a scale Standard Error 0.090	-1.17 units on a scale Standard Error 0.074	-1.19 units on a scale Standard Error 0.073	-1.21 units on a scale Standard Error 0.073	-1.31 units on a scale Standard Error 0.073
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) Watery Eyes Score	-0.44 units on a scale Standard Error 0.089	-0.87 units on a scale Standard Error 0.073	-1.01 units on a scale Standard Error 0.072	-1.00 units on a scale Standard Error 0.073	-1.01 units on a scale Standard Error 0.072

Adverse Events

Placebo (PBO)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Levocetirizine (LCTZ) 2.5 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Levocetirizine (LCTZ) 5 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cetirizine (CTZ) 5 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Cetirizine (CTZ) 10 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo (PBO) n=78 participants at risk A single dose of placebo was administered orally on Day 1.	Levocetirizine (LCTZ) 2.5 mg n=116 participants at risk A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.	Levocetirizine (LCTZ) 5 mg n=119 participants at risk A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.	Cetirizine (CTZ) 5 mg n=119 participants at risk A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.	Cetirizine (CTZ) 10 mg n=119 participants at risk A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Cardiac disorders Palpitations	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Eye disorders Conjunctivitis	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Eye disorders Ocular hyperaemia	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Eye disorders Vision blurred	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Defaecation urgency	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Dry mouth	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	2.5% 3/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Flatulence	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Nausea	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Gastrointestinal disorders Vomiting	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
General disorders Fatigue	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
General disorders Pyrexia	1.3% 1/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Musculoskeletal and connective tissue disorders Neck pain	1.3% 1/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Dizziness	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Headache	2.6% 2/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Paraesthesia	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Somnolence	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Syncope vasovagal	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Psychiatric disorders Nervousness	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	1.7% 2/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Throat tightness	1.3% 1/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Periorbital oedema	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.84% 1/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/78 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.86% 1/116 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/119 • Adverse events were collected from Day 1 until up to 9 days after the study drug intake. Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.

Additional Information

UCB

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Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60