LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

Overview

Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)

Full Title of Study: “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 Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double
• Study Primary Completion Date: September 2005

Interventions

• Drug: Levocetirizine

Clinical Trial Outcome Measures

Primary Measures

• Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

Secondary Measures

• Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety

Participating in This Clinical Trial

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,

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

• Lead Sponsor
  • UCB Pharma
• Overall Official(s)
  • UCB Clinical Trial Call Center, Study Director, UCB Pharma