Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00653224
First received: April 1, 2008
Last updated: August 29, 2011
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: levocetirizine dihydrochloride
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) [ Time Frame: Over the total treatment period (14 days) ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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.

  • Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
    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.


Enrollment: 580
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched placebo tablets
 Drug: placebo
0 mg daily (matching oral tablet) for 14 days
Experimental: LCTZ
5 mg tablet
 Drug: levocetirizine dihydrochloride
5 mg daily (oral tablet) for 14 days
Other Name: Xyzal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653224

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Lawrenceville, Georgia, United States
Stockbridge, Georgia, United States
United States, Illinois
Normal, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Massachusetts
Harvard, Massachusetts, United States
North Dartmouth, Massachusetts, United States
United States, Michigan
Novi, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New Jersey
Berlin, New Jersey, United States
Skillman, New Jersey, United States
Verona, New Jersey, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Edmond, Oklahoma, United States
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Upland, Pennsylvania, United States
United States, Rhode Island
Lincoln, Rhode Island, United States
United States, Tennessee
Germantown, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
South Burlington, Vermont, United States
United States, Virginia
Arlington, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
Product Information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00653224     History of Changes
Other Study ID Numbers: A00431
Study First Received: April 1, 2008
Results First Received: July 28, 2009
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
levocetirizine
Xyzal
Seasonal Allergic Rhinitis
total symptom score
quality of life

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Levocetirizine
 Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013