Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis
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 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial
Allergic Rhinitis.
Clinical Details
Official title: A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: Total 5 Symptom Score (T5SS) rated by the investigator
Secondary outcome: Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI).
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male ore female, 16 to 60 years old (inclusive)
- two-year history of allergic rhinitis due to house dust mite
Exclusion Criteria:
- An ear, nose or throat (ENT) infection
- asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
- atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
- an associated ENT disease
- use of decongestants
- nasal or ocular topical treatment
- desensitivation
Locations and Contacts
Additional Information
Starting date: September 2003
Ending date: February 2004
Last updated: March 6, 2008
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