Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust...
Brief Summary
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”
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: May 2003
Intervention(s) in this Clinical Trial
- Drug: Levocetirizine dihydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- Number of confortable days, as assessed by the subject
- Time Frame: 30 days
- Time Frame: 30 days
Secondary Measures
- Sum of 4 and 5 rhinitis symptoms and safety
- Time Frame: Week 1 and over 30 days
- Time Frame: Week 1 and over 30 days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521131
Study ID Number: A00333
ClinicalTrials.gov Identifier: NCT00521131
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00521131
