Back to resultsEfficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
levocetirizine dihydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Levocetirizine dihydrochloride, Xyzal tablet
Eligibility 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 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
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544388
Brief Title
Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Levocetirizine dihydrochloride, Xyzal tablet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levocetirizine dihydrochloride
Primary Outcome Measure Information:
Title
Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
Secondary Outcome Measure Information:
Title
Mean change from baseline in MSC score over each 2-hour interval.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
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