LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)
Phase 4
Completed
- Conditions
- Rhinitis, Allergic, Perennial
- Registration Number
- NCT00160589
- Lead Sponsor
- UCB Pharma
- Brief Summary
Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 729
Inclusion Criteria
- At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season.
- A skin test for grass pollens positive:
- Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6.
Exclusion Criteria
- Have an associated asthma requiring corticosteroid treatment,
- Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment
- Secondary Outcome Measures
Name Time Method Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety