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

Official Title: “The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.”

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

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride

Primary Measures

• The efficacy based on daily record cards recordings
  • Time Frame: 90 days
    

Secondary Measures

• Safety and pharmacokinetics at 90 days; skin reactivity

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Months

Maximum Age for this Clinical Trial: 24 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director UCB, Inc.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520754

Study ID Number: A00315

ClinicalTrials.gov Identifier: NCT00520754

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration