Seasonal Allergic Rhinitis
Conditions
Keywords
levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life
Brief summary
The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.
Interventions
5 mg daily (oral tablet) for 14 days
DRUGplacebo
0 mg daily (matching oral tablet) for 14 days
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with a history of SAR symptoms * A positive skin prick test at least one grass allergen * Moderate - severe SAR symptoms at baseline * Women of childbearing potential must use a medically acceptable form of contraception * 80% compliance on run in study medication and 80% compliance on completing the diary
Exclusion criteria
* The presence of any clinically significant comorbid disease which may interfere with the study assessments * The presence of renal disease * Pregnant or breastfeeding * Subject is currently participating in another clinical trial * Known hypersensitivity to piperazines or any of the excipients * Intake of medications prohibited before the start of the trial * Subjects who started or changed the dose of immunotherapy * Rhinitis medicamentosa * Subjects with a recent history (within the last 2 years) of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | Over the total treatment period (14 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 | Baseline and week 1 | 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. |
| Total 4 Symptoms Score (T4SS) Over the Second Week | Over week 2 | Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 | Baseline and week 2 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 | Baseline and week 1 | 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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 | Baseline and week 2 | 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. |
| Total 5 Symptoms Score (T5SS) Over the First Week | Over week 1 | Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided. |
| Total 5 Symptoms Score (T5SS) Over the Second Week | Over week 2 | Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided. |
| Total 4 Symptoms Score (T4SS) Over the First Week | Over week 1 | Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided. |
| Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | 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. |
| Total Nasal Symptom Score (TNSS) Over the First Week | Over week 1 | Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided. |
| Total Nasal Symptom Score (TNSS) Over the Second Week | Over week 2 | Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided. |
| Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | 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. |
| Total Ocular Symptom Score (TOSS) Over the First Week | Over week 1 | Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided. |
| Total Ocular Symptom Score (TOSS) Over the Second Week | Over week 2 | Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided. |
| Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | 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. |
| Sneezing Score Over the First Week | Over week 1 | The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Sneezing Score Over the Second Week | Over week 2 | The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Sneezing Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Rhinorrhea Score Over the First Week | Over week 1 | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Rhinorrhea Score Over the Second Week | Over week 2 | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Rhinorrhea Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Nasal Congestion Score Over the First Week | Over week 1 | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Nasal Congestion Score Over the Second Week | Over week 2 | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Nasal Congestion Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Nasal Pruritus Score Over the First Week | Over week 1 | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Nasal Pruritus Score Over the Second Week | Over week 2 | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Nasal Pruritus Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Post-nasal Drip Score Over the First Week | Over week 1 | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Post-nasal Drip Score Over the Second Week | Over week 2 | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Post-nasal Drip Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Ocular Pruritus Score Over the First Week | Over week 1 | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Ocular Pruritus Score Over the Second Week | Over week 2 | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Ocular Pruritus Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Ocular Itching/Burning Score Over the First Week | Over week 1 | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Ocular Itching/Burning Score Over the Second Week | Over week 2 | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Ocular Tearing/Watering Score Over the First Week | Over week 1 | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Ocular Tearing/Watering Score Over the Second Week | Over week 2 | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Ocular Redness Score Over the First Week | Over week 1 | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. |
| Ocular Redness Score Over the Second Week | Over week 2 | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. |
| Ocular Redness Score Over the Total Treatment Period (14 Days) | Over total treatment period (14 days) | The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. |
| Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Baseline and at endpoint of the 2 week treatment period | Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement. |
| Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | 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. |
| Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 | Baseline and week 1 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 | Baseline and week 1 | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. |
| Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 | Baseline and week 2 | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. |
| Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | Baseline and at endpoint of the 2 week treatment period | The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. |
| Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 | Baseline and week 2 | The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching oral placebo tablet daily for 14 days | 293 |
| Levocetirizine Levocetirizine (LCTZ) 5 mg tablet daily for 14 days | 287 |
| Total | 580 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Loss of efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other | 2 | 4 |
Baseline characteristics
| Characteristic | Placebo | Levocetirizine | Total |
|---|---|---|---|
| Age Continuous | 37.53 years STANDARD_DEVIATION 11.68 | 38.73 years STANDARD_DEVIATION 11.5 | 38.13 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 293 participants | 287 participants | 580 participants |
| Sex: Female, Male Female | 182 Participants | 169 Participants | 351 Participants |
| Sex: Female, Male Male | 111 Participants | 118 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 293 | 13 / 285 |
| serious Total, serious adverse events | 0 / 293 | 1 / 285 |
Outcome results
Primary
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | 8.68 points on a scale | Standard Deviation 3.44 |
| Levocetirizine | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) | 7.87 points on a scale | Standard Deviation 3.17 |
Comparison: 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.'p-value: <0.00195% CI: [-1.33, -0.45]ANCOVA
Secondary
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period | -1.02 points on a scale | Standard Deviation 3.84 |
| Levocetirizine | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period | -1.79 points on a scale | Standard Deviation 4.16 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.02795% CI: [-1.29, -0.08]ANCOVA
Secondary
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available ESS score at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 | -0.67 points on a scale | Standard Deviation 3.33 |
| Levocetirizine | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 | -0.91 points on a scale | Standard Deviation 3.65 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.53595% CI: [-0.7, 0.37]ANCOVA
Secondary
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available ESS score at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 | -1.05 points on a scale | Standard Deviation 3.88 |
| Levocetirizine | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 | -1.78 points on a scale | Standard Deviation 4.2 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.04295% CI: [-1.26, -0.02]ANCOVA
Secondary
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | -0.93 points on a scale | Standard Deviation 1.12 |
| Levocetirizine | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period | -1.31 points on a scale | Standard Deviation 1.15 |
Comparison: 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.'p-value: <0.00195% CI: [-0.52, -0.17]ANCOVA
Secondary
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | -0.60 points on a scale | Standard Deviation 0.93 |
| Levocetirizine | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 | -0.94 points on a scale | Standard Deviation 1.09 |
Comparison: 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.'p-value: <0.00195% CI: [-0.47, -0.15]ANCOVA
Secondary
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
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
Population: Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | -0.95 points on a scale | Standard Deviation 1.12 |
| Levocetirizine | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 | -1.34 points on a scale | Standard Deviation 1.15 |
Comparison: 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.'p-value: <0.00195% CI: [-0.52, -0.17]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | -1.28 points on a scale | Standard Deviation 1.39 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period | -1.55 points on a scale | Standard Deviation 1.48 |
Comparison: 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.'p-value: 0.04295% CI: [-0.49, -0.01]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | -0.80 points on a scale | Standard Deviation 1.19 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 | -1.13 points on a scale | Standard Deviation 1.41 |
Comparison: 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.'p-value: 0.01495% CI: [-0.52, -0.06]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | -1.30 points on a scale | Standard Deviation 1.4 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 | -1.58 points on a scale | Standard Deviation 1.48 |
Comparison: 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.'p-value: 0.03695% CI: [-0.51, -0.02]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period | -0.80 points on a scale | Standard Deviation 1.36 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period | -1.21 points on a scale | Standard Deviation 1.37 |
Comparison: 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.'p-value: <0.00195% CI: [-0.53, -0.13]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 | -0.51 points on a scale | Standard Deviation 1.17 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 | -0.91 points on a scale | Standard Deviation 1.29 |
Comparison: 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.'p-value: <0.00195% CI: [-0.52, -0.15]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 | -0.82 points on a scale | Standard Deviation 1.37 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 | -1.24 points on a scale | Standard Deviation 1.35 |
Comparison: 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.'p-value: <0.00195% CI: [-0.53, -0.14]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period | -0.88 points on a scale | Standard Deviation 1.4 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period | -1.36 points on a scale | Standard Deviation 1.41 |
Comparison: 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.'p-value: <0.00195% CI: [-0.63, -0.21]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 | -0.62 points on a scale | Standard Deviation 1.27 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 | -1.04 points on a scale | Standard Deviation 1.32 |
Comparison: 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.'p-value: <0.00195% CI: [-0.56, -0.17]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 | -0.89 points on a scale | Standard Deviation 1.41 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 | -1.40 points on a scale | Standard Deviation 1.4 |
Comparison: 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.'p-value: <0.00195% CI: [-0.63, -0.22]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period | -1.05 points on a scale | Standard Deviation 1.45 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period | -1.45 points on a scale | Standard Deviation 1.33 |
Comparison: 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.'p-value: <0.00195% CI: [-0.59, -0.18]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 | -0.68 points on a scale | Standard Deviation 1.25 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 | -1.05 points on a scale | Standard Deviation 1.25 |
Comparison: 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.'p-value: <0.00195% CI: [-0.55, -0.16]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 | -1.08 points on a scale | Standard Deviation 1.46 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 | -1.49 points on a scale | Standard Deviation 1.31 |
Comparison: 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.'p-value: <0.00195% CI: [-0.59, -0.17]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period | -0.71 points on a scale | Standard Deviation 1.24 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period | -1.05 points on a scale | Standard Deviation 1.26 |
Comparison: 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.'p-value: 0.00295% CI: [-0.47, -0.1]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 | -0.42 points on a scale | Standard Deviation 1.08 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 | -0.70 points on a scale | Standard Deviation 1.14 |
Comparison: 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.'p-value: 0.00695% CI: [-0.41, -0.07]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 | -0.73 points on a scale | Standard Deviation 1.25 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 | -1.08 points on a scale | Standard Deviation 1.26 |
Comparison: 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.'p-value: 0.00395% CI: [-0.47, -0.1]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period | -1.22 points on a scale | Standard Deviation 1.5 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period | -1.62 points on a scale | Standard Deviation 1.4 |
Comparison: 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.'p-value: <0.00195% CI: [-0.61, -0.18]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 | -0.76 points on a scale | Standard Deviation 1.26 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 | -1.14 points on a scale | Standard Deviation 1.41 |
Comparison: 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.'p-value: <0.00195% CI: [-0.57, -0.16]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 | -1.24 points on a scale | Standard Deviation 1.51 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 | -1.66 points on a scale | Standard Deviation 1.38 |
Comparison: 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.'p-value: <0.00195% CI: [-0.61, -0.18]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period
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
Population: Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | -0.90 points on a scale | Standard Deviation 1.38 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period | -1.19 points on a scale | Standard Deviation 1.4 |
Comparison: 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.'p-value: 0.0195% CI: [-0.48, -0.07]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
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
Population: Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | -0.59 points on a scale | Standard Deviation 1.29 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 | -0.84 points on a scale | Standard Deviation 1.32 |
Comparison: 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.'p-value: 0.02695% CI: [-0.43, -0.03]ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
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
Population: Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | -0.93 points on a scale | Standard Deviation 1.37 |
| Levocetirizine | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 | -1.20 points on a scale | Standard Deviation 1.4 |
Comparison: 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.'p-value: 0.01895% CI: [-0.45, -0.04]ANCOVA
Secondary
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | -1.01 percent change | Standard Deviation 6.76 |
| Levocetirizine | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | -2.68 percent change | Standard Deviation 11.55 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.02795% CI: [-2.56, -0.16]ANCOVA
Secondary
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 | -1.33 percent change | Standard Deviation 9.02 |
| Levocetirizine | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 | -2.48 percent change | Standard Deviation 13.79 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.55495% CI: [-1.56, 0.84]ANCOVA
Secondary
Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 | -0.93 percent change | Standard Deviation 6.78 |
| Levocetirizine | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 | -2.83 percent change | Standard Deviation 11.55 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.01595% CI: [-2.72, -0.29]ANCOVA
Secondary
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period | -8.06 percent change | Standard Deviation 23.76 |
| Levocetirizine | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period | -13.98 percent change | Standard Deviation 24.61 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.01695% CI: [-8.34, -0.86]ANCOVA
Secondary
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 | -5.64 percent change | Standard Deviation 20.76 |
| Levocetirizine | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 | -11.23 percent change | Standard Deviation 23.04 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.01795% CI: [-7.88, -0.79]ANCOVA
Secondary
Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 | -8.59 percent change | Standard Deviation 23.57 |
| Levocetirizine | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 | -14.34 percent change | Standard Deviation 24.65 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.02795% CI: [-8.02, -0.47]ANCOVA
Secondary
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -8.61 percent change | Standard Deviation 23.98 |
| Levocetirizine | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -14.49 percent change | Standard Deviation 25.43 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.02395% CI: [-8.25, -0.63]ANCOVA
Secondary
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 | -5.80 percent change | Standard Deviation 20.94 |
| Levocetirizine | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 | -11.77 percent change | Standard Deviation 24 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.01595% CI: [-8.23, -0.89]ANCOVA
Secondary
Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 | -9.14 percent change | Standard Deviation 23.78 |
| Levocetirizine | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 | -14.89 percent change | Standard Deviation 25.45 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.03695% CI: [-7.95, -0.27]ANCOVA
Secondary
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | 0.25 percent change | Standard Deviation 11.5 |
| Levocetirizine | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period | -3.64 percent change | Standard Deviation 12.84 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.10295% CI: [-9.95, 0.93]ANCOVA
Secondary
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 | -2.82 percent change | Standard Deviation 9.16 |
| Levocetirizine | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 | -3.27 percent change | Standard Deviation 14.04 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.49395% CI: [-5.66, 2.78]ANCOVA
Secondary
Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 | -0.03 percent change | Standard Deviation 11.6 |
| Levocetirizine | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 | -3.64 percent change | Standard Deviation 12.84 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.11795% CI: [-9.91, 1.15]ANCOVA
Secondary
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period | -6.33 percent change | Standard Deviation 22.05 |
| Levocetirizine | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period | -7.73 percent change | Standard Deviation 24.09 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.40995% CI: [-15.65, 6.49]ANCOVA
Secondary
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 | -2.86 percent change | Standard Deviation 23.7 |
| Levocetirizine | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 | -6.00 percent change | Standard Deviation 24.66 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.43295% CI: [-16.1, 7.01]ANCOVA
Secondary
Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 | -6.55 percent change | Standard Deviation 22.4 |
| Levocetirizine | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 | -7.73 percent change | Standard Deviation 24.09 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.4595% CI: [-15.46, 6.99]ANCOVA
Secondary
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -5.22 percent change | Standard Deviation 21.53 |
| Levocetirizine | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -8.65 percent change | Standard Deviation 24.78 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.25195% CI: [-17.4, 4.67]ANCOVA
Secondary
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 | -3.05 percent change | Standard Deviation 24.92 |
| Levocetirizine | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 | -7.18 percent change | Standard Deviation 26.96 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.25895% CI: [-19.48, 5.36]ANCOVA
Secondary
Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 | -5.52 percent change | Standard Deviation 21.85 |
| Levocetirizine | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 | -8.65 percent change | Standard Deviation 24.78 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.28895% CI: [-17.13, 5.22]ANCOVA
Secondary
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -11.71 percent change | Standard Deviation 23.4 |
| Levocetirizine | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period | -18.46 percent change | Standard Deviation 24.43 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: <0.00195% CI: [-9.34, -2.47]ANCOVA
Secondary
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 1
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 | -6.85 percent change | Standard Deviation 19.69 |
| Levocetirizine | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 | -14.29 percent change | Standard Deviation 23.32 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: <0.00195% CI: [-9.88, -3.35]ANCOVA
Secondary
Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Time frame: Baseline and week 2
Population: Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 | -12.05 percent change | Standard Deviation 23.53 |
| Levocetirizine | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 | -18.84 percent change | Standard Deviation 24.43 |
Comparison: The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.00195% CI: [-9.16, -2.21]ANCOVA
Secondary
Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period
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
Population: Number of participants from the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Slight Worsening | 21 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Slight Improvement | 81 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Moderate Worsening | 16 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Moderate Improvement | 52 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | No Change | 86 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Marked Improvement | 22 participants |
| Placebo | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Marked Worsening | 14 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Marked Improvement | 33 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Marked Worsening | 6 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Moderate Worsening | 11 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Slight Worsening | 8 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | No Change | 69 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Slight Improvement | 95 participants |
| Levocetirizine | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period | Moderate Improvement | 62 participants |
Comparison: 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.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | No Change | 106 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Slight Improvement | 75 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Marked Worsening | 5 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Moderate Improvement | 50 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Slight Worsening | 18 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Marked Improvement | 25 participants |
| Placebo | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Moderate Worsening | 13 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Marked Improvement | 38 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Marked Worsening | 5 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Moderate Worsening | 7 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Slight Worsening | 7 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Slight Improvement | 92 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | Moderate Improvement | 65 participants |
| Levocetirizine | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period | No Change | 70 participants |
Comparison: The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) 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.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Nasal Congestion Score Over the First Week
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
Population: Number of participants from the ITT population with available nasal congestion score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Congestion Score Over the First Week | 1.98 points on a scale | Standard Deviation 0.78 |
| Levocetirizine | Nasal Congestion Score Over the First Week | 1.92 points on a scale | Standard Deviation 0.76 |
Comparison: 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.'p-value: 0.38495% CI: [-0.15, 0.06]ANCOVA
Secondary
Nasal Congestion Score Over the Second Week
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
Population: Number of participants from the ITT population with available nasal congestion score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Congestion Score Over the Second Week | 1.81 points on a scale | Standard Deviation 0.89 |
| Levocetirizine | Nasal Congestion Score Over the Second Week | 1.67 points on a scale | Standard Deviation 0.84 |
Comparison: 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.'p-value: 0.06395% CI: [-0.24, 0.01]ANCOVA
Secondary
Nasal Congestion Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available nasal congestion score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Congestion Score Over the Total Treatment Period (14 Days) | 1.91 points on a scale | Standard Deviation 0.79 |
| Levocetirizine | Nasal Congestion Score Over the Total Treatment Period (14 Days) | 1.80 points on a scale | Standard Deviation 0.75 |
Comparison: 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.'p-value: 0.12495% CI: [-0.19, 0.02]ANCOVA
Secondary
Nasal Pruritus Score Over the First Week
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
Population: Number of participants from the ITT population with available nasal pruritus score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Pruritus Score Over the First Week | 1.80 points on a scale | Standard Deviation 0.81 |
| Levocetirizine | Nasal Pruritus Score Over the First Week | 1.61 points on a scale | Standard Deviation 0.79 |
Comparison: 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.'p-value: 0.00295% CI: [-0.28, -0.06]ANCOVA
Secondary
Nasal Pruritus Score Over the Second Week
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
Population: Number of participants from the ITT population with available nasal pruritus score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Pruritus Score Over the Second Week | 1.63 points on a scale | Standard Deviation 0.9 |
| Levocetirizine | Nasal Pruritus Score Over the Second Week | 1.45 points on a scale | Standard Deviation 0.84 |
Comparison: 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.'p-value: 0.01695% CI: [-0.28, -0.03]ANCOVA
Secondary
Nasal Pruritus Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nasal Pruritus Score Over the Total Treatment Period (14 Days) | 1.73 points on a scale | Standard Deviation 0.81 |
| Levocetirizine | Nasal Pruritus Score Over the Total Treatment Period (14 Days) | 1.54 points on a scale | Standard Deviation 0.76 |
Comparison: 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.'p-value: 0.00395% CI: [-0.27, -0.06]ANCOVA
Secondary
Ocular Itching/Burning Score Over the First Week
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
Population: Number of participants from the ITT population with available ocular itching/burning score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Itching/Burning Score Over the First Week | 1.58 points on a scale | Standard Deviation 0.9 |
| Levocetirizine | Ocular Itching/Burning Score Over the First Week | 1.53 points on a scale | Standard Deviation 0.86 |
Comparison: 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.'p-value: <0.00195% CI: [-0.3, -0.08]ANCOVA
Secondary
Ocular Itching/Burning Score Over the Second Week
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
Population: Number of participants from the ITT population with available ocular itching/burning score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Itching/Burning Score Over the Second Week | 1.42 points on a scale | Standard Deviation 0.95 |
| Levocetirizine | Ocular Itching/Burning Score Over the Second Week | 1.39 points on a scale | Standard Deviation 0.9 |
Comparison: 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.'p-value: 0.00695% CI: [-0.29, -0.05]ANCOVA
Secondary
Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) | 1.52 points on a scale | Standard Deviation 0.89 |
| Levocetirizine | Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) | 1.47 points on a scale | Standard Deviation 0.84 |
Comparison: 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.'p-value: <0.00195% CI: [-0.29, -0.08]ANCOVA
Secondary
Ocular Pruritus Score Over the First Week
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
Population: Number of participants from the ITT population with available ocular pruritus score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Pruritus Score Over the First Week | 1.65 points on a scale | Standard Deviation 0.85 |
| Levocetirizine | Ocular Pruritus Score Over the First Week | 1.56 points on a scale | Standard Deviation 0.82 |
Comparison: 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.'p-value: <0.00195% CI: [-0.32, -0.1]ANCOVA
Secondary
Ocular Pruritus Score Over the Second Week
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
Population: Number of participants from the ITT population with available ocular pruritus score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Pruritus Score Over the Second Week | 1.52 points on a scale | Standard Deviation 0.92 |
| Levocetirizine | Ocular Pruritus Score Over the Second Week | 1.44 points on a scale | Standard Deviation 0.84 |
Comparison: 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.'p-value: 0.00295% CI: [-0.33, -0.08]ANCOVA
Secondary
Ocular Pruritus Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Pruritus Score Over the Total Treatment Period (14 Days) | 1.59 points on a scale | Standard Deviation 0.84 |
| Levocetirizine | Ocular Pruritus Score Over the Total Treatment Period (14 Days) | 1.51 points on a scale | Standard Deviation 0.79 |
Comparison: 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.'p-value: <0.00195% CI: [-0.32, -0.1]ANCOVA
Secondary
Ocular Redness Score Over the First Week
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
Population: Number of participants from the ITT population with available ocular redness score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Redness Score Over the First Week | 1.31 points on a scale | Standard Deviation 0.91 |
| Levocetirizine | Ocular Redness Score Over the First Week | 1.21 points on a scale | Standard Deviation 0.93 |
Comparison: 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.'p-value: 0.00495% CI: [-0.27, -0.05]ANCOVA
Secondary
Ocular Redness Score Over the Second Week
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
Population: Number of participants from the ITT population with available ocular redness score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Redness Score Over the Second Week | 1.20 points on a scale | Standard Deviation 0.93 |
| Levocetirizine | Ocular Redness Score Over the Second Week | 1.05 points on a scale | Standard Deviation 0.93 |
Comparison: 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.'p-value: <0.00195% CI: [-0.34, -0.1]ANCOVA
Secondary
Ocular Redness Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available ocular redness score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Redness Score Over the Total Treatment Period (14 Days) | 1.27 points on a scale | Standard Deviation 0.89 |
| Levocetirizine | Ocular Redness Score Over the Total Treatment Period (14 Days) | 1.14 points on a scale | Standard Deviation 0.9 |
Comparison: 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.'p-value: <0.00195% CI: [-0.29, -0.08]ANCOVA
Secondary
Ocular Tearing/Watering Score Over the First Week
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
Population: Number of participants from the ITT population with available ocular tearing/watering score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Tearing/Watering Score Over the First Week | 1.40 points on a scale | Standard Deviation 0.91 |
| Levocetirizine | Ocular Tearing/Watering Score Over the First Week | 1.26 points on a scale | Standard Deviation 0.88 |
Comparison: 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.'p-value: <0.00195% CI: [-0.31, -0.1]ANCOVA
Secondary
Ocular Tearing/Watering Score Over the Second Week
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
Population: Number of participants from the ITT population with available ocular tearing/watering score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Tearing/Watering Score Over the Second Week | 1.27 points on a scale | Standard Deviation 0.96 |
| Levocetirizine | Ocular Tearing/Watering Score Over the Second Week | 1.16 points on a scale | Standard Deviation 0.91 |
Comparison: 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.'p-value: 0.01195% CI: [-0.29, -0.04]ANCOVA
Secondary
Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) | 1.34 points on a scale | Standard Deviation 0.89 |
| Levocetirizine | Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) | 1.22 points on a scale | Standard Deviation 0.85 |
Comparison: 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.'p-value: <0.00195% CI: [-0.29, -0.08]ANCOVA
Secondary
Post-nasal Drip Score Over the First Week
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
Population: Number of participants from the ITT population with available post-nasal drip score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-nasal Drip Score Over the First Week | 1.72 points on a scale | Standard Deviation 0.91 |
| Levocetirizine | Post-nasal Drip Score Over the First Week | 1.65 points on a scale | Standard Deviation 0.87 |
Comparison: 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.'p-value: 0.08895% CI: [-0.2, 0.01]ANCOVA
Secondary
Post-nasal Drip Score Over the Second Week
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
Population: Number of participants from the ITT population with available post-nasal drip score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-nasal Drip Score Over the Second Week | 1.55 points on a scale | Standard Deviation 0.99 |
| Levocetirizine | Post-nasal Drip Score Over the Second Week | 1.48 points on a scale | Standard Deviation 0.94 |
Comparison: 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.'p-value: 0.11795% CI: [-0.23, 0.03]ANCOVA
Secondary
Post-nasal Drip Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post-nasal Drip Score Over the Total Treatment Period (14 Days) | 1.64 points on a scale | Standard Deviation 0.91 |
| Levocetirizine | Post-nasal Drip Score Over the Total Treatment Period (14 Days) | 1.57 points on a scale | Standard Deviation 0.85 |
Comparison: 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.'p-value: 0.06595% CI: [-0.21, 0.01]ANCOVA
Secondary
Rhinorrhea Score Over the First Week
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
Population: Number of participants from the ITT population with available rhinorrhea score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Rhinorrhea Score Over the First Week | 1.81 points on a scale | Standard Deviation 0.79 |
| Levocetirizine | Rhinorrhea Score Over the First Week | 1.59 points on a scale | Standard Deviation 0.79 |
Comparison: 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.'p-value: <0.00195% CI: [-0.32, -0.11]ANCOVA
Secondary
Rhinorrhea Score Over the Second Week
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
Population: Number of participants from the ITT population with available rhinorrhea score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Rhinorrhea Score Over the Second Week | 1.63 points on a scale | Standard Deviation 0.91 |
| Levocetirizine | Rhinorrhea Score Over the Second Week | 1.44 points on a scale | Standard Deviation 0.84 |
Comparison: 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.'p-value: 0.00895% CI: [-0.3, -0.05]ANCOVA
Secondary
Rhinorrhea Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Rhinorrhea Score Over the Total Treatment Period (14 Days) | 1.73 points on a scale | Standard Deviation 0.8 |
| Levocetirizine | Rhinorrhea Score Over the Total Treatment Period (14 Days) | 1.53 points on a scale | Standard Deviation 0.76 |
Comparison: 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.'p-value: <0.00195% CI: [-0.3, -0.09]ANCOVA
Secondary
Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score \>= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
Time frame: Baseline and at endpoint of the 2 week treatment period
Population: Number of participants from the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score < 8 at Baseline and < 8 at Endpoint | 66 participants |
| Placebo | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score < 8 at Baseline and ≥ 8 at Endpoint | 16 participants |
| Placebo | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score ≥ 8 at Baseline and < 8 at Endpoint | 46 participants |
| Placebo | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score ≥ 8 at Baseline and ≥ 8 at Endpoint | 165 participants |
| Levocetirizine | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score ≥ 8 at Baseline and ≥ 8 at Endpoint | 151 participants |
| Levocetirizine | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score < 8 at Baseline and < 8 at Endpoint | 63 participants |
| Levocetirizine | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score ≥ 8 at Baseline and < 8 at Endpoint | 57 participants |
| Levocetirizine | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period | ESS score < 8 at Baseline and ≥ 8 at Endpoint | 13 participants |
Comparison: The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'p-value: 0.171Repeated measure analysis (CATMOD)
Secondary
Sneezing Score Over the First Week
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
Population: Number of participants from the ITT population with available sneezing score over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sneezing Score Over the First Week | 1.80 points on a scale | Standard Deviation 0.82 |
| Levocetirizine | Sneezing Score Over the First Week | 1.57 points on a scale | Standard Deviation 0.76 |
Comparison: 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.'p-value: <0.00195% CI: [-0.34, -0.13]ANCOVA
Secondary
Sneezing Score Over the Second Week
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
Population: Number of participants from the ITT population with available sneezing score over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sneezing Score Over the Second Week | 1.62 points on a scale | Standard Deviation 0.88 |
| Levocetirizine | Sneezing Score Over the Second Week | 1.41 points on a scale | Standard Deviation 0.82 |
Comparison: 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.'p-value: <0.00195% CI: [-0.34, -0.09]ANCOVA
Secondary
Sneezing Score Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available sneezing score over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sneezing Score Over the Total Treatment Period (14 Days) | 1.72 points on a scale | Standard Deviation 0.8 |
| Levocetirizine | Sneezing Score Over the Total Treatment Period (14 Days) | 1.50 points on a scale | Standard Deviation 0.73 |
Comparison: 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.'p-value: <0.00195% CI: [-0.33, -0.12]ANCOVA
Secondary
Total 4 Symptoms Score (T4SS) Over the First Week
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
Population: Number of participants from the ITT population with available T4SS over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total 4 Symptoms Score (T4SS) Over the First Week | 7.07 points on a scale | Standard Deviation 2.8 |
| Levocetirizine | Total 4 Symptoms Score (T4SS) Over the First Week | 6.32 points on a scale | Standard Deviation 2.65 |
Comparison: 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.'p-value: <0.00195% CI: [-1.2, -0.49]ANCOVA
Secondary
Total 4 Symptoms Score (T4SS) Over the Second Week
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
Population: Number of participants from the ITT population with available T4SS over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total 4 Symptoms Score (T4SS) Over the Second Week | 6.39 points on a scale | Standard Deviation 3.13 |
| Levocetirizine | Total 4 Symptoms Score (T4SS) Over the Second Week | 5.74 points on a scale | Standard Deviation 2.83 |
Comparison: 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.'p-value: <0.00195% CI: [-1.18, -0.35]ANCOVA
Secondary
Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available T4SS over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) | 6.78 points on a scale | Standard Deviation 2.84 |
| Levocetirizine | Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) | 6.07 points on a scale | Standard Deviation 2.59 |
Comparison: 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.'p-value: <0.00195% CI: [-1.17, -0.45]ANCOVA
Secondary
Total 5 Symptoms Score (T5SS) Over the First Week
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
Population: Number of participants from the ITT population with available T5SS over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total 5 Symptoms Score (T5SS) Over the First Week | 9.04 points on a scale | Standard Deviation 3.37 |
| Levocetirizine | Total 5 Symptoms Score (T5SS) Over the First Week | 8.24 points on a scale | Standard Deviation 3.21 |
Comparison: 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.'p-value: <0.00195% CI: [-1.32, -0.45]ANCOVA
Secondary
Total 5 Symptoms Score (T5SS) Over the Second Week
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
Population: Number of participants from the ITT population with available T5SS over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total 5 Symptoms Score (T5SS) Over the Second Week | 8.20 points on a scale | Standard Deviation 3.8 |
| Levocetirizine | Total 5 Symptoms Score (T5SS) Over the Second Week | 7.41 points on a scale | Standard Deviation 3.5 |
Comparison: 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.'p-value: <0.00195% CI: [-1.39, -0.36]ANCOVA
Secondary
Total Nasal Symptom Score (TNSS) Over the First Week
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
Population: Number of participants from the ITT population with available TNSS over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Nasal Symptom Score (TNSS) Over the First Week | 9.11 points on a scale | Standard Deviation 3.39 |
| Levocetirizine | Total Nasal Symptom Score (TNSS) Over the First Week | 8.34 points on a scale | Standard Deviation 3.17 |
Comparison: 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.'p-value: <0.00195% CI: [-1.17, -0.31]ANCOVA
Secondary
Total Nasal Symptom Score (TNSS) Over the Second Week
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
Population: Number of participants from the ITT population with available TNSS over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Nasal Symptom Score (TNSS) Over the Second Week | 8.23 points on a scale | Standard Deviation 3.82 |
| Levocetirizine | Total Nasal Symptom Score (TNSS) Over the Second Week | 7.45 points on a scale | Standard Deviation 3.52 |
Comparison: 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.'p-value: 0.00595% CI: [-1.26, -0.22]ANCOVA
Secondary
Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available TNSS over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) | 8.73 points on a scale | Standard Deviation 3.45 |
| Levocetirizine | Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) | 7.94 points on a scale | Standard Deviation 3.14 |
Comparison: 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.'p-value: <0.00195% CI: [-1.18, -0.3]ANCOVA
Secondary
Total Ocular Symptom Score (TOSS) Over the First Week
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
Population: Number of participants from the ITT population with available TOSS over Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Ocular Symptom Score (TOSS) Over the First Week | 4.29 points on a scale | Standard Deviation 2.54 |
| Levocetirizine | Total Ocular Symptom Score (TOSS) Over the First Week | 3.99 points on a scale | Standard Deviation 2.44 |
Comparison: 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.'p-value: <0.00195% CI: [-0.87, -0.3]ANCOVA
Secondary
Total Ocular Symptom Score (TOSS) Over the Second Week
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
Population: Number of participants from the ITT population with available TOSS over Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Ocular Symptom Score (TOSS) Over the Second Week | 3.89 points on a scale | Standard Deviation 2.64 |
| Levocetirizine | Total Ocular Symptom Score (TOSS) Over the Second Week | 3.60 points on a scale | Standard Deviation 2.5 |
Comparison: 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.'p-value: <0.00195% CI: [-0.91, -0.24]ANCOVA
Secondary
Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
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)
Population: Number of participants from the ITT population with available TOSS over the Total Treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) | 4.13 points on a scale | Standard Deviation 2.51 |
| Levocetirizine | Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) | 3.82 points on a scale | Standard Deviation 2.39 |
Comparison: 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.'p-value: <0.00195% CI: [-0.86, -0.28]ANCOVA