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

This study has been completed.

First Received: August 24, 2007 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00520754

Purpose

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

Condition	Intervention	Phase
Cough	Drug: levocetirizine dihydrochloride	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cough

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Safety and pharmacokinetics at 90 days; skin reactivity

Enrollment:	15
Study Start Date:	December 2001
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520754

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Publications:

Cranswick N, Turzíkova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7.

Study ID Numbers:	A00315
Study First Received:	August 24, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00520754 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB, Inc.:

levocetirizine dihydrochloride Xyzal tablets

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiration Disorders
Cough
Histamine Agents
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions

Signs and Symptoms
Respiratory Tract Diseases
Histamine Antagonists
Levocetirizine
Therapeutic Uses
Signs and Symptoms, Respiratory
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on February 08, 2010