LEADER (LEvocetirizine And DEsloratadine in 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 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Krassimir Mitchev, MD, PhD, Study Director, Affiliation: UCB
Summary
Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in
patients suffering from Allergic Rhinitis (AR)
Clinical Details
Official title: A Multicentre, Double-Blind, Parallel, Randomized, Placebo-Controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment
Secondary outcome: Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 2-year history of Allergic Rhinitis that became symptomatic during the annual
grass pollen season.
- A skin test for grass pollens positive:
- Have rhinitis symptoms of such severity that the mean T4SS over the baseline period
must be 6.
Exclusion Criteria:
- Have an associated asthma requiring corticosteroid treatment,
- Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the
administration of oral or topical corticosteroids,
Locations and Contacts
Additional Information
Starting date: April 2005
Ending date: September 2005
Last updated: March 6, 2008
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