Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 4
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 tablets
Eligibility Criteria
Inclusion Criteria:
- adults 18 to 55 years both inclusive
- suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
- positive RAST and/or positive skin prick test
- comply with study restrictions
Exclusion Criteria:
- known alcohol or drug addiction or abuse
- known allergy/intolerance to lactose, cellulose, cornstarch
- presence of nasal anatomical deformities leading to > 50% obstruction
- ENT infection within 30 days of the study
- use of disallowed medication
- ongoing desensitization
- known cardiac, renal or hepatic dysfunction
- presenting allergic bronchial asthma
- use of cimetidine
- intending to donate blood during the trial
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
Secondary Outcome Measures
The change from baseline of the mean MSC score over time interval 3
the change from baseline of the mean MSC score over time intervals 1 and 4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542607
Brief Title
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Official Title
Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.
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 tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levocetirizine dihydrochloride
Primary Outcome Measure Information:
Title
Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
Secondary Outcome Measure Information:
Title
The change from baseline of the mean MSC score over time interval 3
Title
the change from baseline of the mean MSC score over time intervals 1 and 4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults 18 to 55 years both inclusive
suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
positive RAST and/or positive skin prick test
comply with study restrictions
Exclusion Criteria:
known alcohol or drug addiction or abuse
known allergy/intolerance to lactose, cellulose, cornstarch
presence of nasal anatomical deformities leading to > 50% obstruction
ENT infection within 30 days of the study
use of disallowed medication
ongoing desensitization
known cardiac, renal or hepatic dysfunction
presenting allergic bronchial asthma
use of cimetidine
intending to donate blood during the trial
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 and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
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