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Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
This study has been completed.
Sponsored by: UCB
Information provided by: UCB
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

MedlinePlus related topics: Cough
Drug Information available for: Levocetirizine dihydrochloride Levocetirizine
U.S. FDA Resources
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.

Further study details as provided by UCB:

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
Investigators
Study Director: Isabelle Campine UCB
  More Information

Publications of Results:
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: April 16, 2008
ClinicalTrials.gov Identifier: NCT00520754  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB:
levocetirizine dihydrochloride Xyzal tablets

Study placed in the following topic categories:
Signs and Symptoms
Respiratory Tract Diseases
Levocetirizine
Respiration Disorders
Histamine phosphate
 Signs and Symptoms, Respiratory
Cough
Cetirizine
Recurrence
Histamine

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Therapeutic Uses
Physiological Effects of Drugs
 Histamine Agents
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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