Trial Outcomes & Findings for Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects (NCT NCT00295022)

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

PHASE4

Target enrollment

418 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

Participant milestones
Measure	Placebo (PBO) Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Study STARTED	105	157	156
Overall Study COMPLETED	104	156	151
Overall Study NOT COMPLETED	1	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (PBO) Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Study Adverse Event	1	1	2
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	0	0	2

Baseline Characteristics

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.	Total Title n=418 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=5 Participants	155 Participants n=7 Participants	156 Participants n=5 Participants	415 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	35.41 years STANDARD_DEVIATION 11.74 • n=5 Participants	34.95 years STANDARD_DEVIATION 11.98 • n=7 Participants	32.98 years STANDARD_DEVIATION 11.72 • n=5 Participants	34.33 years STANDARD_DEVIATION 11.85 • n=4 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	101 Participants n=7 Participants	89 Participants n=5 Participants	250 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	56 Participants n=7 Participants	67 Participants n=5 Participants	168 Participants n=4 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: Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication.

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

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I	-3.46 units on a scale Standard Error 0.49	-6.58 units on a scale Standard Error 0.40	-5.65 units on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

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

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the MSC Score Over Period II	-1.22 units on a scale Standard Error 0.52	-6.35 units on a scale Standard Error 0.42	-3.24 units on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Population: Only patients with valid MSC scores in Period III 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

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=151 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the MSC Score Over Period III	-3.50 units on a scale Standard Error 0.58	-8.62 units on a scale Standard Error 0.47	-6.19 units on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid MSC scores during the Total Treatment Period 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

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)	-3.16 units on a scale Standard Error 0.46	-7.37 units on a scale Standard Error 0.38	-5.48 units on a scale Standard Error 0.38

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 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

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I	-6.16 units on a scale Standard Error 0.75	-10.53 units on a scale Standard Error 0.61	-9.01 units on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

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

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II	-2.45 units on a scale Standard Error 0.76	-9.54 units on a scale Standard Error 0.62	-5.12 units on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Population: Only patients with valid TSC scores in Period III 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

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III	-5.91 units on a scale Standard Error 0.88	-13.39 units on a scale Standard Error 0.72	-9.73 units on a scale Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid TSC scores during the Total Treatment Period 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

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)	-5.53 units on a scale Standard Error 0.72	-11.54 units on a scale Standard Error 0.59	-8.68 units on a scale Standard Error 0.59

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 patients with valid TSC score + Nasal congestion score 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I	-6.57 units on a scale Standard Error 0.80	-11.15 units on a scale Standard Error 0.66	-9.65 units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

Population: Only patients with valid TSC score + Nasal congestion score 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II	-2.65 units on a scale Standard Error 0.80	-9.97 units on a scale Standard Error 0.65	-5.47 units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Population: Only patients with valid TSC score + Nasal congestion score in Period III 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III	-6.35 units on a scale Standard Error 0.94	-14.18 units on a scale Standard Error 0.77	-10.39 units on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid TSC score + Nasal congestion score during the Total Treatment Period 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)	-5.92 units on a scale Standard Error 0.77	-12.21 units on a scale Standard Error 0.63	-9.28 units on a scale Standard Error 0.63

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 patients 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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Individual Symptom Scores Over Period I Runny Nose Score	-0.55 units on a scale Standard Error 0.09	-0.89 units on a scale Standard Error 0.07	-0.86 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over Period I Itchy Nose Score	-0.52 units on a scale Standard Error 0.09	-0.93 units on a scale Standard Error 0.08	-0.85 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period I Sniffles Score	-0.53 units on a scale Standard Error 0.09	-0.93 units on a scale Standard Error 0.08	-0.87 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period I Postnasal Drip Score	-0.65 units on a scale Standard Error 0.10	-0.99 units on a scale Standard Error 0.08	-0.89 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period I Watery Eyes Score	-0.58 units on a scale Standard Error 0.09	-0.94 units on a scale Standard Error 0.07	-0.82 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over Period I Itchy Eyes/Ears Score	-0.69 units on a scale Standard Error 0.09	-1.14 units on a scale Standard Error 0.08	-0.90 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period I Itchy Throat Score	-0.66 units on a scale Standard Error 0.09	-1.00 units on a scale Standard Error 0.07	-0.85 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over Period I Cough Score	-0.71 units on a scale Standard Error 0.06	-0.81 units on a scale Standard Error 0.05	-0.71 units on a scale Standard Error 0.05
Change From Baseline in the Individual Symptom Scores Over Period I Sneezes Score	-0.28 units on a scale Standard Error 0.11	-1.07 units on a scale Standard Error 0.09	-0.68 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period I Nose Blows Score	-1.03 units on a scale Standard Error 0.13	-1.77 units on a scale Standard Error 0.10	-1.59 units on a scale Standard Error 0.10
Change From Baseline in the Individual Symptom Scores Over Period I Nasal Congestion Score	-0.41 units on a scale Standard Error 0.07	-0.62 units on a scale Standard Error 0.06	-0.64 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

Population: Only patients 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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Individual Symptom Scores Over Period II Runny Nose Score	-0.18 units on a scale Standard Error 0.09	-0.85 units on a scale Standard Error 0.08	-0.53 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period II Itchy Nose Score	-0.22 units on a scale Standard Error 0.09	-0.84 units on a scale Standard Error 0.07	-0.40 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period II Sniffles Score	-0.10 units on a scale Standard Error 0.09	-0.83 units on a scale Standard Error 0.08	-0.48 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period II Postnasal Drip Score	-0.37 units on a scale Standard Error 0.09	-0.90 units on a scale Standard Error 0.08	-0.52 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over Period II Watery Eyes Score	-0.20 units on a scale Standard Error 0.11	-0.66 units on a scale Standard Error 0.09	-0.46 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period II Itchy Eyes/Ears Score	-0.18 units on a scale Standard Error 0.10	-0.81 units on a scale Standard Error 0.08	-0.40 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period II Itchy Throat Score	-0.19 units on a scale Standard Error 0.10	-0.78 units on a scale Standard Error 0.08	-0.39 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period II Cough Score	-0.49 units on a scale Standard Error 0.08	-0.70 units on a scale Standard Error 0.06	-0.58 units on a scale Standard Error 0.06
Change From Baseline in the Individual Symptom Scores Over Period II Sneezes Score	-0.19 units on a scale Standard Error 0.14	-1.28 units on a scale Standard Error 0.11	-0.40 units on a scale Standard Error 0.12
Change From Baseline in the Individual Symptom Scores Over Period II Nose Blows Score	-0.38 units on a scale Standard Error 0.15	-1.84 units on a scale Standard Error 0.13	-0.99 units on a scale Standard Error 0.13
Change From Baseline in the Individual Symptom Scores Over Period II Nasal Congestion Score	-0.19 units on a scale Standard Error 0.07	-0.43 units on a scale Standard Error 0.05	-0.35 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Population: Only patients with valid individual symptom scores in Period III were included in the analysis.

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=151 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Individual Symptom Scores Over Period III Runny Nose Score	-0.52 units on a scale Standard Error 0.11	-1.23 units on a scale Standard Error 0.09	-0.93 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Itchy Nose Score	-0.47 units on a scale Standard Error 0.11	-1.25 units on a scale Standard Error 0.09	-0.89 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Sniffles Score	-0.50 units on a scale Standard Error 0.11	-1.26 units on a scale Standard Error 0.09	-0.96 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Postnasal Drip Score	-0.67 units on a scale Standard Error 0.11	-1.32 units on a scale Standard Error 0.09	-0.97 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Watery Eyes Score	-0.36 units on a scale Standard Error 0.11	-1.11 units on a scale Standard Error 0.09	-0.84 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Itchy Eyes/Ears Score	-0.42 units on a scale Standard Error 0.12	-1.34 units on a scale Standard Error 0.10	-0.87 units on a scale Standard Error 0.10
Change From Baseline in the Individual Symptom Scores Over Period III Itchy Throat Score	-0.54 units on a scale Standard Error 0.11	-1.15 units on a scale Standard Error 0.09	-0.86 units on a scale Standard Error 0.09
Change From Baseline in the Individual Symptom Scores Over Period III Cough Score	-0.78 units on a scale Standard Error 0.07	-0.97 units on a scale Standard Error 0.06	-0.84 units on a scale Standard Error 0.06
Change From Baseline in the Individual Symptom Scores Over Period III Sneezes Score	-0.48 units on a scale Standard Error 0.12	-1.40 units on a scale Standard Error 0.10	-0.78 units on a scale Standard Error 0.10
Change From Baseline in the Individual Symptom Scores Over Period III Nose Blows Score	-1.22 units on a scale Standard Error 0.15	-2.32 units on a scale Standard Error 0.12	-1.82 units on a scale Standard Error 0.13
Change From Baseline in the Individual Symptom Scores Over Period III Nasal Congestion Score	-0.43 units on a scale Standard Error 0.08	-0.79 units on a scale Standard Error 0.06	-0.67 units on a scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline to Day 2

Population: Only patients with valid individual symptom scores during the Total Treatment Period were included in the analysis.

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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. The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Runny Nose Score	-0.48 units on a scale Standard Error 0.09	-1.02 units on a scale Standard Error 0.07	-0.84 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Itchy Nose Score	-0.46 units on a scale Standard Error 0.09	-1.05 units on a scale Standard Error 0.07	-0.79 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Sniffles Score	-0.45 units on a scale Standard Error 0.09	-1.05 units on a scale Standard Error 0.07	-0.85 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Postnasal Drip Score	-0.62 units on a scale Standard Error 0.09	-1.11 units on a scale Standard Error 0.07	-0.87 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Watery Eyes Score	-0.44 units on a scale Standard Error 0.09	-0.97 units on a scale Standard Error 0.07	-0.77 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Itchy Eyes/Ears Score	-0.51 units on a scale Standard Error 0.10	-1.17 units on a scale Standard Error 0.08	-0.81 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Itchy Throat Score	-0.54 units on a scale Standard Error 0.09	-1.03 units on a scale Standard Error 0.07	-0.78 units on a scale Standard Error 0.07
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Cough Score	-0.71 units on a scale Standard Error 0.06	-0.86 units on a scale Standard Error 0.05	-0.74 units on a scale Standard Error 0.05
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Sneezes Score	-0.35 units on a scale Standard Error 0.10	-1.23 units on a scale Standard Error 0.08	-0.67 units on a scale Standard Error 0.08
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Nose Blows Score	-1.02 units on a scale Standard Error 0.12	-2.00 units on a scale Standard Error 0.10	-1.58 units on a scale Standard Error 0.10
Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) Nasal Congestion Score	-0.38 units on a scale Standard Error 0.07	-0.67 units on a scale Standard Error 0.05	-0.61 units on a scale Standard Error 0.05

SECONDARY outcome

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

Population: Subjects with no first feeling of improvement were censored at 300 minutes.

During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=66 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=135 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=127 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Time to First Feeling of Improvement During Period I	101.02 minutes Interval 73.02 to 178.02	70.02 minutes Interval 59.02 to 77.02	63.02 minutes Interval 60.02 to 73.02

SECONDARY outcome

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

The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Onset of Action During Period I	NA hours Not applicable for this arm.	1.5 hours	1.5 hours

SECONDARY outcome

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

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Intensity of Action From Baseline in the MSC Score Over Period I < 20%	54.3 percentage of participants	21.0 percentage of participants	32.7 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period I >= 20%	45.7 percentage of participants	79.0 percentage of participants	67.3 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period I < 50%	80.0 percentage of participants	68.8 percentage of participants	67.9 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period I >= 50%	20.0 percentage of participants	31.2 percentage of participants	32.1 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period I < 70%	95.2 percentage of participants	87.9 percentage of participants	92.3 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period I >= 70%	4.8 percentage of participants	12.1 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Intensity of Action From Baseline in the MSC Score Over Period II < 20%	67.3 percentage of participants	32.1 percentage of participants	53.6 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period II >= 20%	32.7 percentage of participants	67.9 percentage of participants	46.4 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period II < 50%	93.3 percentage of participants	63.5 percentage of participants	87.4 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period II >= 50%	6.7 percentage of participants	36.5 percentage of participants	12.6 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period II < 70%	98.1 percentage of participants	83.3 percentage of participants	95.4 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period II >= 70%	1.9 percentage of participants	16.7 percentage of participants	4.6 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: \< 20%, \>=20%, \< 50%, \>=50%, \< 70%, \>=70% change from Baseline.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Intensity of Action From Baseline in the MSC Score Over Period III < 20%	48.1 percentage of participants	16.7 percentage of participants	31.8 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period III >= 20%	51.9 percentage of participants	83.3 percentage of participants	68.2 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period III < 50%	84.6 percentage of participants	48.1 percentage of participants	63.6 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period III >= 50%	15.4 percentage of participants	51.9 percentage of participants	36.4 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period III < 70%	89.4 percentage of participants	69.9 percentage of participants	86.1 percentage of participants
Intensity of Action From Baseline in the MSC Score Over Period III >= 70%	10.6 percentage of participants	30.1 percentage of participants	13.9 percentage of participants

SECONDARY outcome

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

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Variability of Action From Baseline in the MSC Score Over Period I < 20%	54.3 percentage of participants	21.0 percentage of participants	32.7 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period I 20%-35%	15.2 percentage of participants	22.9 percentage of participants	19.2 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period I 35%-50%	10.5 percentage of participants	24.8 percentage of participants	16.0 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period I 50%-65%	12.4 percentage of participants	12.7 percentage of participants	20.5 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period I 65%-80%	4.8 percentage of participants	15.3 percentage of participants	8.3 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period I >=80%	2.9 percentage of participants	3.2 percentage of participants	3.2 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Variability of Action From Baseline in the MSC Score Over Period II < 20%	67.3 percentage of participants	32.1 percentage of participants	53.6 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period II 20%-35%	17.3 percentage of participants	19.2 percentage of participants	16.6 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period II 35%-50%	8.7 percentage of participants	12.2 percentage of participants	17.2 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period II 50%-65%	3.8 percentage of participants	17.3 percentage of participants	6.6 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period II 65%-80%	1.9 percentage of participants	10.3 percentage of participants	3.3 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period II >=80%	1.0 percentage of participants	9.0 percentage of participants	2.6 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following: \< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, \>=80%.

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=105 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=157 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=156 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Variability of Action From Baseline in the MSC Score Over Period III < 20%	48.1 percentage of participants	16.7 percentage of participants	31.8 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period III 20%-35%	21.2 percentage of participants	17.9 percentage of participants	14.6 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period III 35%-50%	15.4 percentage of participants	13.5 percentage of participants	17.2 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period III 50%-65%	3.8 percentage of participants	14.1 percentage of participants	17.2 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period III 65%-80%	8.7 percentage of participants	17.9 percentage of participants	14.6 percentage of participants
Variability of Action From Baseline in the MSC Score Over Period III >=80%	2.9 percentage of participants	19.9 percentage of participants	4.6 percentage of participants

SECONDARY outcome

Timeframe: At the end of Period III (Day 2)

Population: Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis.

Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=152 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Global Satisfaction of the Subjects at the End of Period III	32.42 units on a scale Standard Deviation 31.05	53.94 units on a scale Standard Deviation 32.95	41.80 units on a scale Standard Deviation 32.10

SECONDARY outcome

Timeframe: At the end of Period III (Day 2)

Population: Only subjects with valid data were included in the analysis.

At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no).

Outcome measures

Outcome measures
Measure	Placebo (PBO) n=104 Participants Placebo was administered orally on Days 1 and 2.	Levocetirizine (LCTZ) n=156 Participants 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.	Montelukast (MLKT) n=152 Participants 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season	23.1 percentage of participants	49.4 percentage of participants	32.9 percentage of participants

Adverse Events

Placebo (PBO)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Levocetirizine (LCTZ)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Montelukast (MLKT)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60