Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Phase 4
Completed
- Conditions
- Rhinitis, Allergic, Seasonal
- Registration Number
- NCT00542607
- Lead Sponsor
- UCB Pharma
- Brief Summary
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
Inclusion Criteria
- adults 18 to 55 years both inclusive
- suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
- positive RAST and/or positive skin prick test
- comply with study restrictions
Exclusion Criteria
- known alcohol or drug addiction or abuse
- known allergy/intolerance to lactose, cellulose, cornstarch
- presence of nasal anatomical deformities leading to > 50% obstruction
- ENT infection within 30 days of the study
- use of disallowed medication
- ongoing desensitization
- known cardiac, renal or hepatic dysfunction
- presenting allergic bronchial asthma
- use of cimetidine
- intending to donate blood during the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
- Secondary Outcome Measures
Name Time Method The change from baseline of the mean MSC score over time interval 3 the change from baseline of the mean MSC score over time intervals 1 and 4.