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Trial record 1 of 1 for:    NCT00653224
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A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00653224
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : November 17, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: levocetirizine dihydrochloride
Drug: placebo
Enrollment 580
Recruitment Details 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).
Pre-assignment Details  
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description Matching oral placebo tablet daily for 14 days Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Period Title: Overall Study
Started 293 287
Completed 286 280
Not Completed 7 7
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             1             2
Loss of efficacy             1             0
Lost to Follow-up             1             0
Other             2             4
Arm/Group Title Placebo Levocetirizine Total
Hide Arm/Group Description Matching oral placebo tablet daily for 14 days Levocetirizine (LCTZ) 5 mg tablet daily for 14 days Total of all reporting groups
Overall Number of Baseline Participants 293 287 580
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants 287 participants 580 participants
37.53  (11.68) 38.73  (11.50) 38.13  (11.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 287 participants 580 participants
Female
182
  62.1%
169
  58.9%
351
  60.5%
Male
111
  37.9%
118
  41.1%
229
  39.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 293 participants 287 participants 580 participants
293 287 580
1.Primary Outcome
Title Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
Hide Description 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.
Time Frame Over the total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
8.68  (3.44) 7.87  (3.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis for the primary endpoint is expressed as follows: ‘The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.89
Confidence Interval 95%
-1.33 to -0.45
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
2.Secondary Outcome
Title Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.93  (1.12) -1.31  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.52 to -0.17
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
3.Secondary Outcome
Title Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 288 282
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.60  (0.93) -0.94  (1.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval 95%
-0.47 to -0.15
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
4.Secondary Outcome
Title Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.95  (1.12) -1.34  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.52 to -0.17
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
5.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 241 233
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.28  (1.39) -1.55  (1.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval 95%
-0.49 to -0.01
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
6.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 231 243
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.80  (1.19) -1.13  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval 95%
-0.52 to -0.06
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
7.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 235 229
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.30  (1.40) -1.58  (1.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval 95%
-0.51 to -0.02
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
8.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.90  (1.38) -1.19  (1.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval 95%
-0.48 to -0.07
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
9.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 288 282
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.59  (1.29) -0.84  (1.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval 95%
-0.43 to -0.03
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
10.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.93  (1.37) -1.20  (1.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.25
Confidence Interval 95%
-0.45 to -0.04
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
11.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.71  (1.24) -1.05  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval 95%
-0.47 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
12.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 281
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.42  (1.08) -0.70  (1.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval 95%
-0.41 to -0.07
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
13.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 278
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.73  (1.25) -1.08  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval 95%
-0.47 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
14.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.22  (1.50) -1.62  (1.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval 95%
-0.61 to -0.18
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
15.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 288 282
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.76  (1.26) -1.14  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval 95%
-0.57 to -0.16
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
16.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 278
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.24  (1.51) -1.66  (1.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval 95%
-0.61 to -0.18
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
17.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.05  (1.45) -1.45  (1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval 95%
-0.59 to -0.18
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
18.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 288 282
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.68  (1.25) -1.05  (1.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval 95%
-0.55 to -0.16
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
19.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 278
Mean (Standard Deviation)
Unit of Measure: points on a scale
-1.08  (1.46) -1.49  (1.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval 95%
-0.59 to -0.17
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
20.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.88  (1.40) -1.36  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval 95%
-0.63 to -0.21
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
21.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 287 281
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.62  (1.27) -1.04  (1.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval 95%
-0.56 to -0.17
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
22.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.89  (1.41) -1.40  (1.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval 95%
-0.63 to -0.22
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
23.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period
Hide Description 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.
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.80  (1.36) -1.21  (1.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval 95%
-0.53 to -0.13
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
24.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
Hide Description 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.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 287 281
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.51  (1.17) -0.91  (1.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.52 to -0.15
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
25.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
-0.82  (1.37) -1.24  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.53 to -0.14
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
26.Secondary Outcome
Title Total 5 Symptoms Score (T5SS) Over the First Week
Hide Description 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.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available T5SS over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
9.04  (3.37) 8.24  (3.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.89
Confidence Interval 95%
-1.32 to -0.45
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
27.Secondary Outcome
Title Total 5 Symptoms Score (T5SS) Over the Second Week
Hide Description 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.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available T5SS over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
8.20  (3.80) 7.41  (3.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval 95%
-1.39 to -0.36
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
28.Secondary Outcome
Title Total 4 Symptoms Score (T4SS) Over the First Week
Hide Description 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.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available T4SS over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
7.07  (2.80) 6.32  (2.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.84
Confidence Interval 95%
-1.20 to -0.49
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
29.Secondary Outcome
Title Total 4 Symptoms Score (T4SS) Over the Second Week
Hide Description 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.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available T4SS over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
6.39  (3.13) 5.74  (2.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.76
Confidence Interval 95%
-1.18 to -0.35
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
30.Secondary Outcome
Title Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
Hide Description 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.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available T4SS over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
6.78  (2.84) 6.07  (2.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.81
Confidence Interval 95%
-1.17 to -0.45
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
31.Secondary Outcome
Title Total Nasal Symptom Score (TNSS) Over the First Week
Hide Description 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.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TNSS over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
9.11  (3.39) 8.34  (3.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval 95%
-1.17 to -0.31
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
32.Secondary Outcome
Title Total Nasal Symptom Score (TNSS) Over the Second Week
Hide Description 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.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TNSS over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
8.23  (3.82) 7.45  (3.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval 95%
-1.26 to -0.22
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
33.Secondary Outcome
Title Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
Hide Description 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.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TNSS over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
8.73  (3.45) 7.94  (3.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval 95%
-1.18 to -0.30
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
34.Secondary Outcome
Title Total Ocular Symptom Score (TOSS) Over the First Week
Hide Description 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.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TOSS over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
4.29  (2.54) 3.99  (2.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.59
Confidence Interval 95%
-0.87 to -0.30
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
35.Secondary Outcome
Title Total Ocular Symptom Score (TOSS) Over the Second Week
Hide Description 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.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TOSS over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
3.89  (2.64) 3.60  (2.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval 95%
-0.91 to -0.24
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
36.Secondary Outcome
Title Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
Hide Description 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.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available TOSS over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
4.13  (2.51) 3.82  (2.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval 95%
-0.86 to -0.28
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
37.Secondary Outcome
Title Sneezing Score Over the First Week
Hide Description The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available sneezing score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.80  (0.82) 1.57  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval 95%
-0.34 to -0.13
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
38.Secondary Outcome
Title Sneezing Score Over the Second Week
Hide Description The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available sneezing score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.62  (0.88) 1.41  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval 95%
-0.34 to -0.09
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
39.Secondary Outcome
Title Sneezing Score Over the Total Treatment Period (14 Days)
Hide Description The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available sneezing score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 292 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.72  (0.80) 1.50  (0.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval 95%
-0.33 to -0.12
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
40.Secondary Outcome
Title Rhinorrhea Score Over the First Week
Hide Description The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available rhinorrhea score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.81  (0.79) 1.59  (0.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval 95%
-0.32 to -0.11
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
41.Secondary Outcome
Title Rhinorrhea Score Over the Second Week
Hide Description The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available rhinorrhea score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.63  (0.91) 1.44  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval 95%
-0.30 to -0.05
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
42.Secondary Outcome
Title Rhinorrhea Score Over the Total Treatment Period (14 Days)
Hide Description The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.73  (0.80) 1.53  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval 95%
-0.30 to -0.09
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
43.Secondary Outcome
Title Nasal Congestion Score Over the First Week
Hide Description The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal congestion score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.98  (0.78) 1.92  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.384
Comments If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-0.15 to 0.06
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
44.Secondary Outcome
Title Nasal Congestion Score Over the Second Week
Hide Description The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal congestion score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.81  (0.89) 1.67  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval 95%
-0.24 to 0.01
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
45.Secondary Outcome
Title Nasal Congestion Score Over the Total Treatment Period (14 Days)
Hide Description The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal congestion score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.91  (0.79) 1.80  (0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 95%
-0.19 to 0.02
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
46.Secondary Outcome
Title Nasal Pruritus Score Over the First Week
Hide Description The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal pruritus score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.80  (0.81) 1.61  (0.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval 95%
-0.28 to -0.06
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
47.Secondary Outcome
Title Nasal Pruritus Score Over the Second Week
Hide Description The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal pruritus score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.63  (0.90) 1.45  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval 95%
-0.28 to -0.03
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
48.Secondary Outcome
Title Nasal Pruritus Score Over the Total Treatment Period (14 Days)
Hide Description The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.73  (0.81) 1.54  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval 95%
-0.27 to -0.06
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
49.Secondary Outcome
Title Post-nasal Drip Score Over the First Week
Hide Description The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available post-nasal drip score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.72  (0.91) 1.65  (0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval 95%
-0.20 to 0.01
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
50.Secondary Outcome
Title Post-nasal Drip Score Over the Second Week
Hide Description The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available post-nasal drip score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.55  (0.99) 1.48  (0.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval 95%
-0.23 to 0.03
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
51.Secondary Outcome
Title Post-nasal Drip Score Over the Total Treatment Period (14 Days)
Hide Description The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.64  (0.91) 1.57  (0.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval 95%
-0.21 to 0.01
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
52.Secondary Outcome
Title Ocular Pruritus Score Over the First Week
Hide Description The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular pruritus score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 284
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.65  (0.85) 1.56  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval 95%
-0.32 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
53.Secondary Outcome
Title Ocular Pruritus Score Over the Second Week
Hide Description The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular pruritus score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 286 279
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.52  (0.92) 1.44  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval 95%
-0.33 to -0.08
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
54.Secondary Outcome
Title Ocular Pruritus Score Over the Total Treatment Period (14 Days)
Hide Description The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.59  (0.84) 1.51  (0.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval 95%
-0.32 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
55.Secondary Outcome
Title Ocular Itching/Burning Score Over the First Week
Hide Description The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular itching/burning score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.58  (0.90) 1.53  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval 95%
-0.30 to -0.08
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
56.Secondary Outcome
Title Ocular Itching/Burning Score Over the Second Week
Hide Description The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular itching/burning score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.42  (0.95) 1.39  (0.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval 95%
-0.29 to -0.05
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
57.Secondary Outcome
Title Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
Hide Description The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.52  (0.89) 1.47  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval 95%
-0.29 to -0.08
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
58.Secondary Outcome
Title Ocular Tearing/Watering Score Over the First Week
Hide Description The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular tearing/watering score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.40  (0.91) 1.26  (0.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval 95%
-0.31 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
59.Secondary Outcome
Title Ocular Tearing/Watering Score Over the Second Week
Hide Description The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular tearing/watering score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.27  (0.96) 1.16  (0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval 95%
-0.29 to -0.04
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
60.Secondary Outcome
Title Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
Hide Description The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.34  (0.89) 1.22  (0.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval 95%
-0.29 to -0.08
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
61.Secondary Outcome
Title Ocular Redness Score Over the First Week
Hide Description The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.
Time Frame Over week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular redness score over Week 1
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.31  (0.91) 1.21  (0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval 95%
-0.27 to -0.05
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
62.Secondary Outcome
Title Ocular Redness Score Over the Second Week
Hide Description The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.
Time Frame Over week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular redness score over Week 2
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 285 280
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.20  (0.93) 1.05  (0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval 95%
-0.34 to -0.10
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
63.Secondary Outcome
Title Ocular Redness Score Over the Total Treatment Period (14 Days)
Hide Description The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.
Time Frame Over total treatment period (14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population with available ocular redness score over the Total Treatment period
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 285
Mean (Standard Deviation)
Unit of Measure: points on a scale
1.27  (0.89) 1.14  (0.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.
Method ANCOVA
Comments ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval 95%
-0.29 to -0.08
Estimation Comments The difference presented is 'Levocetirizine 5 mg - Placebo'
64.Secondary Outcome
Title Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period
Hide Description 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".
Time Frame Baseline and at endpoint of the 2 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants from the ITT population
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Matching oral placebo tablet daily for 14 days
Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
Overall Number of Participants Analyzed 293 287
Measure Type: Number
Unit of Measure: participants
Marked Worsening 14 6
Moderate Worsening 16 11
Slight Worsening 21 8
No Change 86 69
Slight Improvement 81 95
Moderate Improvement 52 62
Marked Improvement 22 33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levocetirizine
Comments The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect ‘shift alternatives’. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]