Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

UCB

Status and phase: Completed; Phase 2

Conditions: Cough

Treatments: Drug: levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520754

A00315

Details and patient eligibility

About

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Enrollment: 15 patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infants from 2 to 24 months both inclusive
• suffering from recurrent cough associated with other allergic symptoms
• hospitalized for respiratory or allergy related problems
• laboratory results within normal ranges
• height and weight between percentile 5 and 95

Exclusion criteria

• having taken any of the disallowed medication
• suffering form any disorder
• history of sleep apnea
• having concomitant chronic disease
• known relevant renal, hepatic, cardiac or metabolism dysfunction
• known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)