Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: levocetirizine dihydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Marie-Etienne Pinelli, MD, Study Director, Affiliation: UCB
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.
Clinical Details
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).
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
Secondary outcome: Mean change from baseline in MSC score over each 2-hour interval.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2004
Ending date: July 2004
Last updated: March 6, 2008
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