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

Phase 4

Completed

• Conditions: Rhinitis; Allergic; Perennial

• Registration Number: NCT00521131
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of comfortable days, as assessed by the subject	30 days

Secondary Outcome Measures

Name	Time	Method
Sum of 4 and 5 rhinitis symptoms and safety	Week 1 and over 30 days