Evaluation of a treatment with levocetirizine in children allergic to mites suffering for recurrent respiratory infections with or without concomitant asthma symptoms - ND

• Conditions: persistent allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10039085Term: Rhinitis allergic

• Registration Number: EUCTR2006-006379-19-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

males and females 2-6 years old children with persistent rhinitis allergic to mites
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. Acute respiratory infections in the last 30 month before the enrolment . Persistent asthma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of a trimestrial treatment with levocetirizine versus placebo on allergic nasal symtomps;Secondary Objective: To compare the efficacy of a monthly treatment with levocetirizine versus placebo on allergic nasal symtomps;Primary end point(s): To compare the efficacy of a trimestrial treatment with levocetirizine versus placebo on allergic nasal symtomps