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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
596
5mg daily (oral tablet) for 14 days
0mg (matching oral tablet)for 14 days
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Hot Springs, Arkansas, United States
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.
Time frame: Over the total treatment period (14 days)
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.
Time frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
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Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Mission Viejo, California, United States
Unnamed facility
Albany, Georgia, United States
Unnamed facility
Lilburn, Georgia, United States
Unnamed facility
Savannah, Georgia, United States
...and 16 more locations