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

Verified by: UCB, Inc., December 2009
First Received: April 1, 2008 | Last Updated: August 29, 2011 | Phase: Phase 4 | Start Date: April 2008
Overall Status: Completed | Estimated Enrollment: 580
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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...

Brief Summary

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”

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
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

  • Drug: levocetirizine dihydrochloride
    • 5 mg daily (oral tablet) for 14 days
  • Drug: placebo
    • 0 mg daily (matching oral tablet) for 14 days

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Placebo
    • Matched placebo tablets
  • Experimental: LCTZ
    • 5 mg tablet

Outcome Measures for this Clinical Trial

Primary 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)
      Safety Issue?: No

Secondary 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
      Safety Issue?: No
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • Total 5 Symptoms Score (T5SS) Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Total 5 Symptoms Score (T5SS) Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Total 4 Symptoms Score (T4SS) Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Total 4 Symptoms Score (T4SS) Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Total Nasal Symptom Score (TNSS) Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Total Nasal Symptom Score (TNSS) Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Total Ocular Symptom Score (TOSS) Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Total Ocular Symptom Score (TOSS) Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Sneezing Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Sneezing Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Sneezing Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Rhinorrhea Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Rhinorrhea Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Rhinorrhea Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Nasal Congestion Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Nasal Congestion Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Nasal Congestion Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Nasal Pruritus Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Nasal Pruritus Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Nasal Pruritus Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Post-nasal Drip Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Post-nasal Drip Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Post-nasal Drip Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Ocular Pruritus Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Ocular Pruritus Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Ocular Pruritus Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Ocular Itching/Burning Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Ocular Itching/Burning Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Ocular Tearing/Watering Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Ocular Tearing/Watering Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • Ocular Redness Score Over the First Week
    • Time Frame: Over week 1
      Safety Issue?: No
  • Ocular Redness Score Over the Second Week
    • Time Frame: Over week 2
      Safety Issue?: No
  • Ocular Redness Score Over the Total Treatment Period (14 Days)
    • Time Frame: Over total treatment period (14 days)
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1
    • Time Frame: Baseline and week 1
      Safety Issue?: No
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
    • Time Frame: Baseline and week 2
      Safety Issue?: No
  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653224

Study ID Number: A00431

ClinicalTrials.gov Identifier: NCT00653224

Health Authority: United States: Food and Drug Administration

FDA Safety Alerts and Recalls

Product Information

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