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Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: October 15, 2007
Last updated: December 13, 2013
Last verified: September 2009
Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: levocetirizine dihydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary Outcome Measures:
  • Mean change from baseline in MSC score over each 2-hour interval.

Enrollment: 570
Study Start Date: April 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male/Female, aged >= 16 years
  • seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
  • documented seasonal allergy to ragweed pollen
  • total symptom score of at least 18 points.

Exclusion Criteria:

  • nasal anatomic deformities ? 50% obstruction
  • acute sinusitis within 30 days of Period 2
  • initiated or advanced an immunotherapy regimen
  • immunotherapy injections within 48 hours of pollen exposure
  • impaired hepatic function
  • history of malignancy
  • intolerance to histamines
  • asthma requiring medication more than occasionally
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Please refer to this study by its identifier: NCT00544388

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

Additional Information: Identifier: NCT00544388     History of Changes
Other Study ID Numbers: A00379
Study First Received: October 15, 2007
Last Updated: December 13, 2013

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablet

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 April 28, 2017