Trial Outcomes & Findings for A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis (NCT NCT00653224)

NCT ID: NCT00653224

Last Updated: 2011-08-31

Results Overview

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 580 participants
• Primary outcome timeframe: Over the total treatment period (14 days)
• Results posted on: 2011-08-31

Participant Flow

A total of 580 patients has been recruited and randomized. Baseline Characteristics describe all randomized subjects. Out of the 580 randomized subjects (ITT population), 578 subjects have been treated at least once (Safety population).

Participant milestones

Measure	Placebo Matching oral placebo tablet daily for 14 days	Levocetirizine Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Study STARTED	293	287
Overall Study COMPLETED	286	280
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	Placebo Matching oral placebo tablet daily for 14 days	Levocetirizine Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	1	2
Overall Study Loss of efficacy	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Other	2	4

Baseline Characteristics

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=287 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days	Total n=580 Participants Total of all reporting groups
Age Continuous	37.53 years STANDARD_DEVIATION 11.68 • n=5 Participants	38.73 years STANDARD_DEVIATION 11.50 • n=7 Participants	38.13 years STANDARD_DEVIATION 11.60 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	169 Participants n=7 Participants	351 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	118 Participants n=7 Participants	229 Participants n=5 Participants
Region of Enrollment United States	293 participants n=5 Participants	287 participants n=7 Participants	580 participants n=5 Participants

PRIMARY outcome

Timeframe: Over the total treatment period (14 days)

Population: Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)	8.68 points on a scale Standard Deviation 3.44	7.87 points on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period	-0.93 points on a scale Standard Deviation 1.12	-1.31 points on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.

Outcome measures

Measure	Placebo n=288 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=282 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1	-0.60 points on a scale Standard Deviation 0.93	-0.94 points on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2	-0.95 points on a scale Standard Deviation 1.12	-1.34 points on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=241 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=233 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period	-1.28 points on a scale Standard Deviation 1.39	-1.55 points on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=231 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=243 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1	-0.80 points on a scale Standard Deviation 1.19	-1.13 points on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=235 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=229 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2	-1.30 points on a scale Standard Deviation 1.40	-1.58 points on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period	-0.90 points on a scale Standard Deviation 1.38	-1.19 points on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=288 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=282 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1	-0.59 points on a scale Standard Deviation 1.29	-0.84 points on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2	-0.93 points on a scale Standard Deviation 1.37	-1.20 points on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period	-0.71 points on a scale Standard Deviation 1.24	-1.05 points on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=281 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1	-0.42 points on a scale Standard Deviation 1.08	-0.70 points on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=278 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2	-0.73 points on a scale Standard Deviation 1.25	-1.08 points on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period	-1.22 points on a scale Standard Deviation 1.50	-1.62 points on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=288 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=282 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1	-0.76 points on a scale Standard Deviation 1.26	-1.14 points on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=278 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2	-1.24 points on a scale Standard Deviation 1.51	-1.66 points on a scale Standard Deviation 1.38

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period	-1.05 points on a scale Standard Deviation 1.45	-1.45 points on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=288 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=282 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1	-0.68 points on a scale Standard Deviation 1.25	-1.05 points on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=278 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2	-1.08 points on a scale Standard Deviation 1.46	-1.49 points on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period	-0.88 points on a scale Standard Deviation 1.40	-1.36 points on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=287 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=281 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1	-0.62 points on a scale Standard Deviation 1.27	-1.04 points on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2	-0.89 points on a scale Standard Deviation 1.41	-1.40 points on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period	-0.80 points on a scale Standard Deviation 1.36	-1.21 points on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=287 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=281 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1	-0.51 points on a scale Standard Deviation 1.17	-0.91 points on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2	-0.82 points on a scale Standard Deviation 1.37	-1.24 points on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available T5SS over Week 1

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total 5 Symptoms Score (T5SS) Over the First Week	9.04 points on a scale Standard Deviation 3.37	8.24 points on a scale Standard Deviation 3.21

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available T5SS over Week 2

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total 5 Symptoms Score (T5SS) Over the Second Week	8.20 points on a scale Standard Deviation 3.80	7.41 points on a scale Standard Deviation 3.50

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available T4SS over Week 1

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total 4 Symptoms Score (T4SS) Over the First Week	7.07 points on a scale Standard Deviation 2.80	6.32 points on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available T4SS over Week 2

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total 4 Symptoms Score (T4SS) Over the Second Week	6.39 points on a scale Standard Deviation 3.13	5.74 points on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available T4SS over the Total Treatment period

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)	6.78 points on a scale Standard Deviation 2.84	6.07 points on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available TNSS over Week 1

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Nasal Symptom Score (TNSS) Over the First Week	9.11 points on a scale Standard Deviation 3.39	8.34 points on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available TNSS over Week 2

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Nasal Symptom Score (TNSS) Over the Second Week	8.23 points on a scale Standard Deviation 3.82	7.45 points on a scale Standard Deviation 3.52

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available TNSS over the Total Treatment period

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)	8.73 points on a scale Standard Deviation 3.45	7.94 points on a scale Standard Deviation 3.14

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available TOSS over Week 1

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Ocular Symptom Score (TOSS) Over the First Week	4.29 points on a scale Standard Deviation 2.54	3.99 points on a scale Standard Deviation 2.44

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available TOSS over Week 2

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Ocular Symptom Score (TOSS) Over the Second Week	3.89 points on a scale Standard Deviation 2.64	3.60 points on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available TOSS over the Total Treatment period

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)	4.13 points on a scale Standard Deviation 2.51	3.82 points on a scale Standard Deviation 2.39

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available sneezing score over Week 1

The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Sneezing Score Over the First Week	1.80 points on a scale Standard Deviation 0.82	1.57 points on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available sneezing score over Week 2

The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Sneezing Score Over the Second Week	1.62 points on a scale Standard Deviation 0.88	1.41 points on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available sneezing score over the Total Treatment period

The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=292 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Sneezing Score Over the Total Treatment Period (14 Days)	1.72 points on a scale Standard Deviation 0.80	1.50 points on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available rhinorrhea score over Week 1

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Rhinorrhea Score Over the First Week	1.81 points on a scale Standard Deviation 0.79	1.59 points on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available rhinorrhea score over Week 2

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Rhinorrhea Score Over the Second Week	1.63 points on a scale Standard Deviation 0.91	1.44 points on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Rhinorrhea Score Over the Total Treatment Period (14 Days)	1.73 points on a scale Standard Deviation 0.80	1.53 points on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available nasal congestion score over Week 1

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Congestion Score Over the First Week	1.98 points on a scale Standard Deviation 0.78	1.92 points on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available nasal congestion score over Week 2

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Congestion Score Over the Second Week	1.81 points on a scale Standard Deviation 0.89	1.67 points on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available nasal congestion score over the Total Treatment period

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Congestion Score Over the Total Treatment Period (14 Days)	1.91 points on a scale Standard Deviation 0.79	1.80 points on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available nasal pruritus score over Week 1

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Pruritus Score Over the First Week	1.80 points on a scale Standard Deviation 0.81	1.61 points on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available nasal pruritus score over Week 2

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Pruritus Score Over the Second Week	1.63 points on a scale Standard Deviation 0.90	1.45 points on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nasal Pruritus Score Over the Total Treatment Period (14 Days)	1.73 points on a scale Standard Deviation 0.81	1.54 points on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available post-nasal drip score over Week 1

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Post-nasal Drip Score Over the First Week	1.72 points on a scale Standard Deviation 0.91	1.65 points on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available post-nasal drip score over Week 2

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Post-nasal Drip Score Over the Second Week	1.55 points on a scale Standard Deviation 0.99	1.48 points on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Post-nasal Drip Score Over the Total Treatment Period (14 Days)	1.64 points on a scale Standard Deviation 0.91	1.57 points on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available ocular pruritus score over Week 1

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Pruritus Score Over the First Week	1.65 points on a scale Standard Deviation 0.85	1.56 points on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available ocular pruritus score over Week 2

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=279 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Pruritus Score Over the Second Week	1.52 points on a scale Standard Deviation 0.92	1.44 points on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Pruritus Score Over the Total Treatment Period (14 Days)	1.59 points on a scale Standard Deviation 0.84	1.51 points on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available ocular itching/burning score over Week 1

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Itching/Burning Score Over the First Week	1.58 points on a scale Standard Deviation 0.90	1.53 points on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available ocular itching/burning score over Week 2

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Itching/Burning Score Over the Second Week	1.42 points on a scale Standard Deviation 0.95	1.39 points on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)	1.52 points on a scale Standard Deviation 0.89	1.47 points on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available ocular tearing/watering score over Week 1

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Tearing/Watering Score Over the First Week	1.40 points on a scale Standard Deviation 0.91	1.26 points on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available ocular tearing/watering score over Week 2

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Tearing/Watering Score Over the Second Week	1.27 points on a scale Standard Deviation 0.96	1.16 points on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)	1.34 points on a scale Standard Deviation 0.89	1.22 points on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Over week 1

Population: Number of participants from the ITT population with available ocular redness score over Week 1

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Redness Score Over the First Week	1.31 points on a scale Standard Deviation 0.91	1.21 points on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Over week 2

Population: Number of participants from the ITT population with available ocular redness score over Week 2

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.

Outcome measures

Measure	Placebo n=285 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Redness Score Over the Second Week	1.20 points on a scale Standard Deviation 0.93	1.05 points on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: Over total treatment period (14 days)

Population: Number of participants from the ITT population with available ocular redness score over the Total Treatment period

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Ocular Redness Score Over the Total Treatment Period (14 Days)	1.27 points on a scale Standard Deviation 0.89	1.14 points on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population

Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from "Marked worsening" to "Marked improvement".

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=287 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Marked Worsening	14 participants	6 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Moderate Worsening	16 participants	11 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Slight Worsening	21 participants	8 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period No Change	86 participants	69 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Slight Improvement	81 participants	95 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Moderate Improvement	52 participants	62 participants
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period Marked Improvement	22 participants	33 participants

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population

Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from "Marked worsening" to "Marked improvement".

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=287 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Marked Worsening	5 participants	5 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Moderate Worsening	13 participants	7 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Slight Worsening	18 participants	7 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period No Change	106 participants	70 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Slight Improvement	75 participants	92 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Moderate Improvement	50 participants	65 participants
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period Marked Improvement	25 participants	38 participants

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=225 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=214 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period	-1.01 percent change Standard Deviation 6.76	-2.68 percent change Standard Deviation 11.55

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=223 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=216 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1	-1.33 percent change Standard Deviation 9.02	-2.48 percent change Standard Deviation 13.79

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=218 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=210 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2	-0.93 percent change Standard Deviation 6.78	-2.83 percent change Standard Deviation 11.55

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=227 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=216 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period	-8.06 percent change Standard Deviation 23.76	-13.98 percent change Standard Deviation 24.61

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=225 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=219 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1	-5.64 percent change Standard Deviation 20.76	-11.23 percent change Standard Deviation 23.04

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=220 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=212 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2	-8.59 percent change Standard Deviation 23.57	-14.34 percent change Standard Deviation 24.65

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=223 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=214 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period	-8.61 percent change Standard Deviation 23.98	-14.49 percent change Standard Deviation 25.43

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=221 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=216 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1	-5.80 percent change Standard Deviation 20.94	-11.77 percent change Standard Deviation 24.00

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=216 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=210 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2	-9.14 percent change Standard Deviation 23.78	-14.89 percent change Standard Deviation 25.45

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=30 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period	0.25 percent change Standard Deviation 11.50	-3.64 percent change Standard Deviation 12.84

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=27 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=24 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1	-2.82 percent change Standard Deviation 9.16	-3.27 percent change Standard Deviation 14.04

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=29 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2	-0.03 percent change Standard Deviation 11.60	-3.64 percent change Standard Deviation 12.84

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=30 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period	-6.33 percent change Standard Deviation 22.05	-7.73 percent change Standard Deviation 24.09

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=28 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=25 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1	-2.86 percent change Standard Deviation 23.70	-6.00 percent change Standard Deviation 24.66

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=29 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2	-6.55 percent change Standard Deviation 22.40	-7.73 percent change Standard Deviation 24.09

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=30 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period	-5.22 percent change Standard Deviation 21.53	-8.65 percent change Standard Deviation 24.78

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=27 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=24 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1	-3.05 percent change Standard Deviation 24.92	-7.18 percent change Standard Deviation 26.96

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=29 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=22 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2	-5.52 percent change Standard Deviation 21.85	-8.65 percent change Standard Deviation 24.78

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=280 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=273 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period	-11.71 percent change Standard Deviation 23.40	-18.46 percent change Standard Deviation 24.43

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=279 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=273 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1	-6.85 percent change Standard Deviation 19.69	-14.29 percent change Standard Deviation 23.32

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.

Outcome measures

Measure	Placebo n=273 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=267 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2	-12.05 percent change Standard Deviation 23.53	-18.84 percent change Standard Deviation 24.43

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline

The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=284 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period	-1.02 points on a scale Standard Deviation 3.84	-1.79 points on a scale Standard Deviation 4.16

SECONDARY outcome

Timeframe: Baseline and week 1

Population: Number of participants from the ITT population with available ESS score at Week 1 and at Baseline

The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.

Outcome measures

Measure	Placebo n=288 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=280 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1	-0.67 points on a scale Standard Deviation 3.33	-0.91 points on a scale Standard Deviation 3.65

SECONDARY outcome

Timeframe: Baseline and week 2

Population: Number of participants from the ITT population with available ESS score at Week 2 and at Baseline

The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.

Outcome measures

Measure	Placebo n=286 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=278 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2	-1.05 points on a scale Standard Deviation 3.88	-1.78 points on a scale Standard Deviation 4.20

SECONDARY outcome

Timeframe: Baseline and at endpoint of the 2 week treatment period

Population: Number of participants from the ITT population

The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.

Outcome measures

Measure	Placebo n=293 Participants Matching oral placebo tablet daily for 14 days	Levocetirizine n=287 Participants Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period ESS score < 8 at Baseline and < 8 at Endpoint	66 participants	63 participants
Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period ESS score < 8 at Baseline and ≥ 8 at Endpoint	16 participants	13 participants
Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period ESS score ≥ 8 at Baseline and < 8 at Endpoint	46 participants	57 participants
Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period ESS score ≥ 8 at Baseline and ≥ 8 at Endpoint	165 participants	151 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Levocetirizine

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=293 participants at risk Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 participants at risk Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Infections and infestations Cellulitis	0.00% 0/293 • 14 days Safety population consists of all randomized subjects treated at least once during two week treatment period (578 subjects).	0.35% 1/285 • 14 days Safety population consists of all randomized subjects treated at least once during two week treatment period (578 subjects).

Other adverse events

Measure	Placebo n=293 participants at risk Matching oral placebo tablet daily for 14 days	Levocetirizine n=285 participants at risk Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Nervous system disorders Headache	4.1% 12/293 • 14 days Safety population consists of all randomized subjects treated at least once during two week treatment period (578 subjects).	4.6% 13/285 • 14 days Safety population consists of all randomized subjects treated at least once during two week treatment period (578 subjects).

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

• Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
• Publication restrictions are in place

Restriction type: OTHER