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...
Date First Received: October 15, 2007
Last Updated: March 6, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 3 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 570
Brief Summary
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).”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Study Primary Completion Date: July 2004
Intervention(s) in this Clinical Trial
- Drug: levocetirizine dihydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
Secondary Measures
- Mean change from baseline in MSC score over each 2-hour interval.
Criteria for Participation in this Clinical Trial
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 sinusitus within 30 days of Period 2
- initiatedor advanced an immunotherapy regimen
- immunotherapy injections within 48 hours of pollen exposure
- impaired hepatic function
- history of malignancy
- intolerance to histamines
- astma requiring medication more than occasional
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Marie-Etienne Pinelli, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00544388
Study ID Number: A00379
ClinicalTrials.gov Identifier: NCT00544388
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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