Allergic, Rhinitis, Seasonal
Conditions
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
Brief summary
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Interventions
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 60 years old, inclusive * two-year history of allergic rhinitis due to tree, grass or weed pollen * sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)
Exclusion criteria
* An ear, nose or throat (ENT) infection * asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn * atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment * an associated ENT disease * use of decongestants * nasal or ocular topical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator rated T5SS (Total 5 symptom Score) over 2 weeks | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI). | 2 weeks |
Outcome results
None listed