Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Not Applicable
Completed
- Conditions
- Rhinitis, Allergic, Seasonal
- Registration Number
- NCT00521040
- Lead Sponsor
- UCB Pharma
- Brief Summary
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 459
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus) 12 weeks
- Secondary Outcome Measures
Name Time Method 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