To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Phase 3

Completed

• Conditions: Allergic; Rhinitis; Seasonal

• Registration Number: NCT00525278
• Lead Sponsor: UCB Pharma

Brief Summary

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2003-10
• Study Completion: 2003-10
• 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: 67

Inclusion Criteria

• Male or female, 18 to 60 years old, inclusive
• two-year history of allergic rhinitis due to tree, grass or weed pollen
• sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Investigator rated T5SS (Total 5 symptom Score) over 2 weeks	2 weeks

Secondary Outcome Measures

Name	Time	Method
Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI).	2 weeks