Rhinitis, Allergic, Seasonal
Conditions
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
Brief summary
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
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 subjects ≥ 12 years * 2 year history of seasonal allergic rhinitis * documented hypersensitivity to local seasonal allergens (grass pollen) * documented pollen-induced asthma * without acute ongoing exacerbation of asthma or allergic rhinitis * no continuous ongoing treatment for rhinitis or asthma
Exclusion criteria
* non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity * symptomatic rhinitis or asthma due to tree pollens * currently treated by specific grass pollen immunotherapy * suffering from non-allergic asthma * chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma * atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids * contraindication for salbutamol use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season | 12 weeks |
Outcome results
None listed