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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: March 2003

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 Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine Study Director UCB  

Information obtained from ClinicalTrials.gov on September 05, 2008

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