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

Last updated: December 13, 2013
Sponsor: UCB Pharma
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT00544388
A00379
  • Ages > 16
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male/Female, aged >= 16 years

  • seasonal allergic rhinitis that required pharmacologic therapy each year during thelast 2 ragweed pollen seasons

  • documented seasonal allergy to ragweed pollen

  • total symptom score of at least 18 points.

Exclusion

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

Study Design

Total Participants: 570
Study Start date:
April 01, 2004
Estimated Completion Date:
July 31, 2004