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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

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

Primary Measures

• Mean 24-hr reflective T5SS (the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes)
  • Time Frame: over the total treatment period
    Safety Issue?: No

Secondary Measures

• Change from baseline in overall RQLQ score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in overall RQLQ score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in overall RQLQ score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ activities score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ activities score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ activities score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ sleep score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ sleep score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ sleep score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ non-nose/eye symptoms score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ non-nose/eye symptoms score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ non-nose/eye symptoms score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ practical problems score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ practical problems score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ practical problems score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ nasal symptoms score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ nasal symptoms score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ nasal symptoms score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ eye symptoms score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ eye symptoms score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ eye symptoms score
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in RQLQ emotional score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in RQLQ emotional score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in RQLQ emotional score
  • Time Frame: At week 2
    Safety Issue?: No
• T5SS
  • Time Frame: Over week 1
    Safety Issue?: No
• T5SS
  • Time Frame: Over week 2
    Safety Issue?: No
• T4SS (sum of rhinorrhea, sneezing, itchy nose and itchy eyes)
  • Time Frame: Over week 1
    Safety Issue?: No
• T4SS (sum of rhinorrhea, sneezing, itchy nose and itchy eyes)
  • Time Frame: Over week 2
    Safety Issue?: No
• T4SS (sum of rhinorrhea, sneezing, itchy nose and itchy eyes)
  • Time Frame: Over total treatment period
    Safety Issue?: No
• TNSS (sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip)
  • Time Frame: Over week 1
    Safety Issue?: No
• TNSS (sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip)
  • Time Frame: Over week 2
    Safety Issue?: No
• TNSS (sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip)
  • Time Frame: Over total treatment period
    Safety Issue?: No
• TOSS (sum of ocular itching/burning, ocular tearing/watering and ocular redness)
  • Time Frame: Over week 1
    Safety Issue?: No
• TOSS (sum of ocular itching/burning, ocular tearing/watering and ocular redness)
  • Time Frame: Over week 2
    Safety Issue?: No
• TOSS (sum of ocular itching/burning, ocular tearing/watering and ocular redness)
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Sneezing score
  • Time Frame: Over week 1
    Safety Issue?: No
• Sneezing score
  • Time Frame: Over week 2
    Safety Issue?: No
• Sneezing score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Rhinorrhea score
  • Time Frame: Over week 1
    Safety Issue?: No
• Rhinorrhea score
  • Time Frame: Over week 2
    Safety Issue?: No
• Rhinorrhea score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Nasal Congestion score
  • Time Frame: Over week 1
    Safety Issue?: No
• Nasal congestion score
  • Time Frame: Over week 2
    Safety Issue?: No
• Nasal congestion score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Nasal pruritus score
  • Time Frame: Over week 1
    Safety Issue?: No
• Nasal pruritus score
  • Time Frame: Over week 2
    Safety Issue?: No
• Nasal pruritus score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Post-nasal drip score
  • Time Frame: Over week 1
    Safety Issue?: No
• Post-nasal drip score
  • Time Frame: Over week 2
    Safety Issue?: No
• Post-nasal drip score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Ocular pruritus score
  • Time Frame: Over week 1
    Safety Issue?: No
• Ocular pruritus score
  • Time Frame: Over week 2
    Safety Issue?: No
• Ocular pruritus score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Ocular itching/burning score
  • Time Frame: Over week 1
    Safety Issue?: No
• Ocular itching/burning score
  • Time Frame: Over week 2
    Safety Issue?: No
• Ocular itching/burning score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Ocular tearing/watering score
  • Time Frame: Over week 1
    Safety Issue?: No
• Ocular tearing/watering score
  • Time Frame: Over week 2
    Safety Issue?: No
• Ocular tearing/watering score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Ocular redness score
  • Time Frame: Over week 1
    Safety Issue?: No
• Ocular redness score
  • Time Frame: Over week 2
    Safety Issue?: No
• Ocular redness score
  • Time Frame: Over total treatment period
    Safety Issue?: No
• Global Patient's rating of efficacy
  • Time Frame: At the final visit (V4/EDV)
    Safety Issue?: No
• Global Physician's rating of efficacy
  • Time Frame: At the final visit (V4/EDV)
    Safety Issue?: No
• Change from baseline in the dimension 1 WPAI-AS score: percentage of work time missed due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 1 WPAI-AS score: percentage of work time missed due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 1 WPAI-AS score: percentage of work time missed due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 2 WPAI-AS score: percentage of impairment while working due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 2 WPAI-AS score: percentage of impairment while working due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 2 WPAI-AS score: percentage of impairment while working due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 3 WPAI-AS score: percentage of overall work impairment due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 3 WPAI-AS score: percentage of overall work impairment due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 3 WPAI-AS score: percentage of overall work impairment due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 4 WPAI-AS score: percentage of class time missed due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 4 WPAI-AS score: percentage of class time missed due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 4 WPAI-AS score: percentage of class time missed due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 5 WPAI-AS score: percentage of impairment in the classroom due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 5 WPAI-AS score: percentage of impairment in the classroom due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 5 WPAI-AS score: percentage of impairment in the classroom due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 6 WPAI-AS score: percentage of overall classroom impairment due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 6 WPAI-AS score: percentage of overall classroom impairment due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 6 WPAI-AS score: percentage of overall classroom impairment due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in the dimension 7 WPAI-AS score: percentage of activity impairment due to allergy
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in the dimension 7 WPAI-AS score: percentage of activity impairment due to allergy
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in the dimension 7 WPAI-AS score: percentage of activity impairment due to allergy
  • Time Frame: At week 2
    Safety Issue?: No
• Change from baseline in ESS score
  • Time Frame: At endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Change from baseline in ESS score
  • Time Frame: At week 1
    Safety Issue?: No
• Change from baseline in ESS score
  • Time Frame: At week 2
    Safety Issue?: No
• Percentage of subjects with an ESS score < 8 at Baseline and ESS score < 8 at Endpoint
  • Time Frame: Endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Percentage of subjects with an ESS score < 8 at Baseline and ESS score ≥ 8 at Endpoint
  • Time Frame: Endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Percentage of subjects with an ESS score ≥ 8 at Baseline and ESS score < 8 at Endpoint
  • Time Frame: Endpoint, defined as the last available post-baseline observation
    Safety Issue?: No
• Percentage of subjects with an ESS score ≥ 8 at Baseline and ESS score ≥ 8 at Endpoint
  • Time Frame: Endpoint, defined as the last available post-baseline observation
    Safety Issue?: No

Inclusion Criteria:

• Subjects with a history of SAR symptoms
• A positive skin prick test at least one grass allergen
• Moderate - severe SAR symptoms at baseline
• Women of childbearing potential must use a medically acceptable form of contraception
• 80% compliance on run in study medication and 80% compliance on completing the diary

Exclusion Criteria:

• The presence of any clinically significant comorbid disease which may interfere with the study assessments
• The presence of renal disease
• Pregnant or breastfeeding
• Subject is currently participating in another clinical trial
• Known hypersensitivity to piperazines or any of the excipients
• Intake of medications prohibited before the start of the trial
• Subjects who started or changed the dose of immunotherapy
• Rhinitis medicamentosa
• Subjects with a recent history (within the last 2 years) of drug or alcohol abuse

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

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

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