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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: levocetirizine dihydrochloride
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matched placebo tablets once daily | Drug: placebo<br>* 0mg (matching oral tablet)for 14 days<br>|
| Experimental: LCTZ<br>5 mg levocetirizine dihydrochloride tablet | Drug: levocetirizine dihydrochloride<br>* 5mg daily (oral tablet) for 14 days<br>* Other names: Xyzal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) | 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). The total score varies from 0 to 15. | Over the total treatment period (14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score | 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. The overall RQLQ score varies from 0 to 6. | Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life