Official Title: “Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites”

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Study Type: Interventional

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

Study Primary Completion Date: May 2003

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine dihydrochloride

Primary Measures

• Number of confortable days, as assessed by the subject
  • Time Frame: 30 days
    

Secondary Measures

• Sum of 4 and 5 rhinitis symptoms and safety
  • Time Frame: Week 1 and over 30 days
    

Inclusion Criteria:

• male or female ≥ 12 years
• suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
• positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
• the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion Criteria:

• seasonal allergic rhinitis likely to change significantly the symptoms of the subject
• an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
• asthma requiring corticosteroid treatment
• atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
• associated ENT disease

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 September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521131

Study ID Number: A00333

ClinicalTrials.gov Identifier: NCT00521131

Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences