Back to resultsEvaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Primary Purpose
Rhinitis, Allergic, Perennial
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 focused on measuring Levocetirizine dihydrochloride, Xyzal tablets
Eligibility Criteria
Inclusion Criteria:
- male or female ≥ 12 years
- suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
- positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
- the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
Exclusion Criteria:
- seasonal allergic rhinitis likely to change significantly the symptoms of the subject
- an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
- asthma requiring corticosteroid treatment
- atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
- associated ENT disease
Sites / Locations
Outcomes
Primary Outcome Measures
Number of comfortable days, as assessed by the subject
Secondary Outcome Measures
Sum of 4 and 5 rhinitis symptoms and safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521131
Brief Title
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Official Title
Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis 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, Perennial
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
453 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levocetirizine dihydrochloride
Primary Outcome Measure Information:
Title
Number of comfortable days, as assessed by the subject
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Sum of 4 and 5 rhinitis symptoms and safety
Time Frame
Week 1 and over 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female ≥ 12 years
suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
Exclusion Criteria:
seasonal allergic rhinitis likely to change significantly the symptoms of the subject
an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
asthma requiring corticosteroid treatment
atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
associated ENT disease
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
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
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