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临床试验/NCT00653224
NCT00653224已完成4 期

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

UCB Pharma0 个研究点目标入组 580 人开始时间: 2008年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
UCB Pharma
入组人数
580
主要终点
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

Matched placebo tablets

干预措施: placebo (Drug)

LCTZ

Experimental

5 mg tablet

干预措施: levocetirizine dihydrochloride (Drug)

结局指标

主要结局

Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)

时间窗: 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.

次要结局

  • Post-nasal Drip Score Over the First Week(Over week 1)
  • 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)
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1(Baseline and week 1)
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2(Baseline and week 2)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2(Baseline and week 2)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2(Baseline and week 2)
  • Sneezing Score Over the Second Week(Over week 2)
  • Rhinorrhea Score Over the First Week(Over week 1)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2(Baseline and week 2)
  • Post-nasal Drip Score Over the Second Week(Over week 2)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2(Baseline and week 2)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2(Baseline and week 2)
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2(Baseline and week 2)
  • Sneezing Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • 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)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1(Baseline and week 1)
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2(Baseline and week 2)
  • Total 5 Symptoms Score (T5SS) Over the First Week(Over week 1)
  • Total 5 Symptoms Score (T5SS) Over the Second Week(Over week 2)
  • Post-nasal Drip Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Total 4 Symptoms Score (T4SS) Over the First Week(Over week 1)
  • Total 4 Symptoms Score (T4SS) Over the Second Week(Over week 2)
  • Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Total Nasal Symptom Score (TNSS) Over the First Week(Over week 1)
  • Total Nasal Symptom Score (TNSS) Over the Second Week(Over week 2)
  • Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Total Ocular Symptom Score (TOSS) Over the First Week(Over week 1)
  • Total Ocular Symptom Score (TOSS) Over the Second Week(Over week 2)
  • Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Sneezing Score Over the First Week(Over week 1)
  • Rhinorrhea Score Over the Second Week(Over week 2)
  • Rhinorrhea Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Nasal Congestion Score Over the First Week(Over week 1)
  • Nasal Congestion Score Over the Second Week(Over week 2)
  • Nasal Congestion Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Nasal Pruritus Score Over the First Week(Over week 1)
  • Nasal Pruritus Score Over the Second Week(Over week 2)
  • Nasal Pruritus Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Ocular Pruritus Score Over the First Week(Over week 1)
  • Ocular Pruritus Score Over the Second Week(Over week 2)
  • Ocular Pruritus Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Ocular Itching/Burning Score Over the First Week(Over week 1)
  • Ocular Itching/Burning Score Over the Second Week(Over week 2)
  • Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Ocular Tearing/Watering Score Over the First Week(Over week 1)
  • Ocular Tearing/Watering Score Over the Second Week(Over week 2)
  • Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Ocular Redness Score Over the First Week(Over week 1)
  • Ocular Redness Score Over the Second Week(Over week 2)
  • Ocular Redness Score Over the Total Treatment Period (14 Days)(Over total treatment period (14 days))
  • Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period(Baseline and at endpoint of the 2 week treatment period)
  • Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period(Baseline and at endpoint of the 2 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 Endpoint During the Two-week Treatment Period(Baseline and at endpoint of the 2 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1(Baseline and week 1)
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2(Baseline and week 2)
  • 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)

研究者

发起方
UCB Pharma
申办方类型
Industry
责任方
Sponsor

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