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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
580
5 mg daily (oral tablet) for 14 days
0 mg daily (matching oral tablet) for 14 days
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)
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
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
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.
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Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
San Jose, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Gainesville, Georgia, United States
...and 28 more locations
Time frame: Baseline and week 2
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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