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Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: October 10, 2007
Last updated: December 11, 2013
Last verified: September 2009
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Drug: levocetirizine dihydrochloride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcome Measures:
  • The change from baseline of the mean MSC score over time interval 3
  • the change from baseline of the mean MSC score over time intervals 1 and 4.

Enrollment: 94
Study Start Date: September 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults 18 to 55 years both inclusive
  • suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
  • positive RAST and/or positive skin prick test
  • comply with study restrictions

Exclusion Criteria:

  • known alcohol or drug addiction or abuse
  • known allergy/intolerance to lactose, cellulose, cornstarch
  • presence of nasal anatomical deformities leading to > 50% obstruction
  • ENT infection within 30 days of the study
  • use of disallowed medication
  • ongoing desensitization
  • known cardiac, renal or hepatic dysfunction
  • presenting allergic bronchial asthma
  • use of cimetidine
  • intending to donate blood during the trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT00542607

Sponsors and Collaborators
UCB Pharma
Study Director: UCb Clinical Trial Call Center UCB Pharma
  More Information

Additional Information: Identifier: NCT00542607     History of Changes
Other Study ID Numbers: A00324
Study First Received: October 10, 2007
Last Updated: December 11, 2013

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents processed this record on September 25, 2017