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

Phase 4

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: placebo
Drug: levocetirizine dihydrochloride

Registration Number: NCT00653224

Lead Sponsor: UCB Pharma

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 580

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matched placebo tablets
LCTZ	levocetirizine dihydrochloride	5 mg tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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 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 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.
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.