Allergic, Perennial, Rhinitis
Conditions
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
Brief summary
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Interventions
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female ≥ 12 years * suffering from a perennial allergic rhinitis to house dust mites for at least 2 years * positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites * the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
Exclusion criteria
* seasonal allergic rhinitis likely to change significantly the symptoms of the subject * an ear, nose or throat (ENT) infection during the two weeks preceding initial visit * asthma requiring corticosteroid treatment * atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids * associated ENT disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of comfortable days, as assessed by the subject | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Sum of 4 and 5 rhinitis symptoms and safety | Week 1 and over 30 days |
Outcome results
None listed