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

Phase 3

Completed

• Conditions: Rhinitis; Allergic; Perennial

• Registration Number: NCT00524836
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total 5 Symptom Score (T5SS) rated by the investigator	2 weeks

Secondary Outcome Measures

Name	Time	Method
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).	2 weeks