Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis; Allergic; Perennial
Intervention: Levocetirizine dihydrochloride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic
Rhinitis to House Dust Mites
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Number of confortable days, as assessed by the subject
Secondary outcome: Sum of 4 and 5 rhinitis symptoms and safety
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2002
Ending date: May 2003
Last updated: March 6, 2008
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