- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653224
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
August 29, 2011 updated by: UCB Pharma
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
580
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States
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California
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Los Angeles, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Florida
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Miami, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Stockbridge, Georgia, United States
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Illinois
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Normal, Illinois, United States
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Kentucky
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Louisville, Kentucky, United States
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Massachusetts
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Harvard, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Michigan
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Novi, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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New Jersey
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Berlin, New Jersey, United States
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Skillman, New Jersey, United States
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Verona, New Jersey, United States
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New York
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Rochester, New York, United States
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North Carolina
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Oklahoma
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Rhode Island
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Lincoln, Rhode Island, United States
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Tennessee
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Germantown, Tennessee, United States
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Texas
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San Antonio, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Vermont
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South Burlington, Vermont, United States
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Virginia
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Arlington, Virginia, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matched placebo tablets
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0 mg daily (matching oral tablet) for 14 days
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Experimental: LCTZ
5 mg tablet
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5 mg daily (oral tablet) for 14 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
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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 at Endpoint During the Two-week Treatment Period
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
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 and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
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Baseline and at endpoint of the 2 week treatment period
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
Time Frame: Baseline and week 1
|
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 and ranges from 0 to 6.
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Baseline and week 1
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
Time Frame: Baseline and week 2
|
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 and ranges from 0 to 6.
|
Baseline and week 2
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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
|
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.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
Baseline and week 2
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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
|
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.
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
|
Baseline and at endpoint of the 2 week treatment period
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
Baseline and week 2
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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
|
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.
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
|
Baseline and at endpoint of the 2 week treatment period
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
Baseline and week 2
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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
|
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.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
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.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
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.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
Baseline and week 2
|
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
|
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.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
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.
|
Baseline and week 1
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
Time Frame: Baseline and week 2
|
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.
|
Baseline and week 2
|
Total 5 Symptoms Score (T5SS) Over the First Week
Time Frame: Over week 1
|
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).
T5SS ranges from 0 to 15.
An average over the first week is provided.
|
Over week 1
|
Total 5 Symptoms Score (T5SS) Over the Second Week
Time Frame: Over week 2
|
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).
T5SS ranges from 0 to 15.
An average over the second week of treatment is provided.
|
Over week 2
|
Total 4 Symptoms Score (T4SS) Over the First Week
Time Frame: Over week 1
|
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
T4SS ranges from 0 to 12.
An average over the first week of treatment is provided.
|
Over week 1
|
Total 4 Symptoms Score (T4SS) Over the Second Week
Time Frame: Over week 2
|
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
T4SS ranges from 0 to 12.
An average over the second week of treatment is provided.
|
Over week 2
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Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
T4SS ranges from 0 to 12.
An average over the total treatment period of 14 days is provided.
|
Over total treatment period (14 days)
|
Total Nasal Symptom Score (TNSS) Over the First Week
Time Frame: Over week 1
|
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TNSS ranges from 0 to 15.
An average over the first week of treatment is provided.
|
Over week 1
|
Total Nasal Symptom Score (TNSS) Over the Second Week
Time Frame: Over week 2
|
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TNSS ranges from 0 to 15.
An average over the second week of treatment is provided.
|
Over week 2
|
Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TNSS ranges from 0 to 15.
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Total Ocular Symptom Score (TOSS) Over the First Week
Time Frame: Over week 1
|
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TOSS ranges from 0 to 9.
An average over the first week of treatment is provided.
|
Over week 1
|
Total Ocular Symptom Score (TOSS) Over the Second Week
Time Frame: Over week 2
|
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TOSS ranges from 0 to 9.
An average over the second week of treatment is provided.
|
Over week 2
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Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores.
Each individual symptom was scored from 0 (none) to 3 (severe).
TOSS ranges from 0 to 9.
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Sneezing Score Over the First Week
Time Frame: Over week 1
|
The sneezing score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
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Sneezing Score Over the Second Week
Time Frame: Over week 2
|
The sneezing score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Sneezing Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The sneezing score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Rhinorrhea Score Over the First Week
Time Frame: Over week 1
|
The rhinorrhea score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
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Rhinorrhea Score Over the Second Week
Time Frame: Over week 2
|
The rhinorrhea score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Rhinorrhea Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The rhinorrhea score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Nasal Congestion Score Over the First Week
Time Frame: Over week 1
|
The nasal congestion score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Nasal Congestion Score Over the Second Week
Time Frame: Over week 2
|
The nasal congestion score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Nasal Congestion Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The nasal congestion score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Nasal Pruritus Score Over the First Week
Time Frame: Over week 1
|
The nasal pruritus score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Nasal Pruritus Score Over the Second Week
Time Frame: Over week 2
|
The nasal pruritus score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Nasal Pruritus Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The nasal pruritus score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Post-nasal Drip Score Over the First Week
Time Frame: Over week 1
|
The post-nasal drip score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Post-nasal Drip Score Over the Second Week
Time Frame: Over week 2
|
The post-nasal drip score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Post-nasal Drip Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The post-nasal drip score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Ocular Pruritus Score Over the First Week
Time Frame: Over week 1
|
The ocular pruritus score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Ocular Pruritus Score Over the Second Week
Time Frame: Over week 2
|
The ocular pruritus score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Ocular Pruritus Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The ocular pruritus score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Ocular Itching/Burning Score Over the First Week
Time Frame: Over week 1
|
The ocular itching/burning score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Ocular Itching/Burning Score Over the Second Week
Time Frame: Over week 2
|
The ocular itching/burning score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The ocular itching/burning score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Ocular Tearing/Watering Score Over the First Week
Time Frame: Over week 1
|
The ocular tearing/watering score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Ocular Tearing/Watering Score Over the Second Week
Time Frame: Over week 2
|
The ocular tearing/watering score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The ocular tearing/watering score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
Ocular Redness Score Over the First Week
Time Frame: Over week 1
|
The ocular redness score ranges from 0 (none) to 3 (severe).
An average over the first week of treatment is provided.
|
Over week 1
|
Ocular Redness Score Over the Second Week
Time Frame: Over week 2
|
The ocular redness score ranges from 0 (none) to 3 (severe).
An average over the second week of treatment is provided.
|
Over week 2
|
Ocular Redness Score Over the Total Treatment Period (14 Days)
Time Frame: Over total treatment period (14 days)
|
The ocular redness score ranges from 0 (none) to 3 (severe).
An average over the total treatment period is provided.
|
Over total treatment period (14 days)
|
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
|
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from "Marked worsening" to "Marked improvement".
|
Baseline and at endpoint of the 2 week treatment period
|
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
|
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from "Marked worsening" to "Marked improvement".
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and at endpoint of the 2 week treatment period
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
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
Time Frame: Baseline and week 2
|
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity.
Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.
|
Baseline and week 2
|
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
|
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults.
Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24.
A score >= 8 indicates sleepiness.
Endpoint is defined as the last available postbaseline measurement 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
Time Frame: Baseline and week 1
|
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults.
Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24.
A score >= 8 indicates sleepiness.
|
Baseline and week 1
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
Time Frame: Baseline and week 2
|
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults.
Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24.
A score >= 8 indicates sleepiness.
|
Baseline and week 2
|
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
|
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults.
Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24.
A score >= 8 indicates sleepiness.
Endpoint is defined as the last available postbaseline measurement during the two week treatment period.
|
Baseline and at endpoint of the 2 week treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 3, 2008
First Posted (Estimate)
April 4, 2008
Study Record Updates
Last Update Posted (Estimate)
August 31, 2011
Last Update Submitted That Met QC Criteria
August 29, 2011
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Levocetirizine
Other Study ID Numbers
- A00431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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