LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160589

Enrollment

729

Registered

2005-09-12

Start date

2005-04-30

Completion date

2005-09-30

Last updated

2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

Allergic Rhinits, Symptoms (sneezing, rhinorrhea, nasal/ocular pruritus, nasal congestion), LEADER, Xyzal, Levocetirizine

Brief summary

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

Interventions

DRUGLevocetirizine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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,

Design outcomes

Primary

Measure	Time frame
Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026