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

Rhinitis, Allergic, Seasonal Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544388
• Other study ID #: A00379
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2007
• Last updated: December 13, 2013
• Start date: April 2004
• Est. completion date: July 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• levocetirizine dihydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
Secondary	Mean change from baseline in MSC score over each 2-hour interval.

External Links

•   Clinical Study Summary on UCB.com