Official Title: “A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.”

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Study Primary Completion Date: February 2004

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride

Primary Measures

• Total 5 Symptom Score (T5SS) rated by the investigator
  • Time Frame: 2 weeks
    

Secondary Measures

• Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI).
  • Time Frame: 2 weeks
    

Inclusion Criteria:

• Male ore female, 16 to 60 years old (inclusive)
• two-year history of allergic rhinitis due to house dust mite

Exclusion Criteria:

• An ear, nose or throat (ENT) infection
• asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
• atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
• an associated ENT disease
• use of decongestants
• nasal or ocular topical treatment
• desensitivation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

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/NCT00524836

Study ID Number: A00349

ClinicalTrials.gov Identifier: NCT00524836

Health Authority: China: Ministry of Health