Clinical trial NCT00653224: A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: levocetirizine
Xyzal
Seasonal Allergic Rhinitis
total symptom score
quality of life
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
timeFrame: Over the total treatment period (14 days)
Secondary outcomes:
measure: Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
timeFrame: Baseline and week 2
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
timeFrame: Baseline and week 2
measure: Total 5 Symptoms Score (T5SS) Over the First Week
timeFrame: Over week 1
measure: Total 5 Symptoms Score (T5SS) Over the Second Week
timeFrame: Over week 2
measure: Total 4 Symptoms Score (T4SS) Over the First Week
timeFrame: Over week 1
measure: Total 4 Symptoms Score (T4SS) Over the Second Week
timeFrame: Over week 2
measure: Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Total Nasal Symptom Score (TNSS) Over the First Week
timeFrame: Over week 1
measure: Total Nasal Symptom Score (TNSS) Over the Second Week
timeFrame: Over week 2
measure: Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Total Ocular Symptom Score (TOSS) Over the First Week
timeFrame: Over week 1
measure: Total Ocular Symptom Score (TOSS) Over the Second Week
timeFrame: Over week 2
measure: Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Sneezing Score Over the First Week
timeFrame: Over week 1
measure: Sneezing Score Over the Second Week
timeFrame: Over week 2
measure: Sneezing Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Rhinorrhea Score Over the First Week
timeFrame: Over week 1
measure: Rhinorrhea Score Over the Second Week
timeFrame: Over week 2
measure: Rhinorrhea Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Nasal Congestion Score Over the First Week
timeFrame: Over week 1
measure: Nasal Congestion Score Over the Second Week
timeFrame: Over week 2
measure: Nasal Congestion Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Nasal Pruritus Score Over the First Week
timeFrame: Over week 1
measure: Nasal Pruritus Score Over the Second Week
timeFrame: Over week 2
measure: Nasal Pruritus Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Post-nasal Drip Score Over the First Week
timeFrame: Over week 1
measure: Post-nasal Drip Score Over the Second Week
timeFrame: Over week 2
measure: Post-nasal Drip Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Ocular Pruritus Score Over the First Week
timeFrame: Over week 1
measure: Ocular Pruritus Score Over the Second Week
timeFrame: Over week 2
measure: Ocular Pruritus Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Ocular Itching/Burning Score Over the First Week
timeFrame: Over week 1
measure: Ocular Itching/Burning Score Over the Second Week
timeFrame: Over week 2
measure: Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Ocular Tearing/Watering Score Over the First Week
timeFrame: Over week 1
measure: Ocular Tearing/Watering Score Over the Second Week
timeFrame: Over week 2
measure: Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Ocular Redness Score Over the First Week
timeFrame: Over week 1
measure: Ocular Redness Score Over the Second Week
timeFrame: Over week 2
measure: Ocular Redness Score Over the Total Treatment Period (14 Days)
timeFrame: Over total treatment period (14 days)
measure: Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: 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
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: 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
timeFrame: Baseline and week 1
measure: 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
timeFrame: Baseline and week 2
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1
timeFrame: Baseline and week 1
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
timeFrame: Baseline and week 2
measure: Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period
timeFrame: Baseline and at endpoint of the 2 week treatment period
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Jose
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Lawrenceville
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Normal
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Harvard
country: United States
state: Massachusetts
city: North Dartmouth
country: United States
state: Massachusetts
city: Novi
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Berlin
country: United States
state: New Jersey
city: Skillman
country: United States
state: New Jersey
city: Verona
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Edmond
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Lincoln
country: United States
state: Rhode Island
city: Germantown
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: South Burlington
country: United States
state: Vermont
city: Arlington
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: