Official Title: “Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-Induced Asthma”

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Study Primary Completion Date: July 2004

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine dihydrochloride

Primary Measures

• T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
  • Time Frame: 12 weeks
    

Secondary Measures

• 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
  • Time Frame: 12 weeks
    

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 corticosteroiddependent asthma
• atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
• contraindication for salbutamol use

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521040

Study ID Number: A00306

ClinicalTrials.gov Identifier: NCT00521040

Health Authority: Belgium: Federal Agency for Medicines and Health Products