To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Phase 3CompletedNCT00525278

UCB Pharma67 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rhinitis Allergic Seasonal

Interventions

Levocetirizine dihydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, 18 to 60 years old, inclusive * two-year history of allergic rhinitis due to tree, grass or weed pollen * sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5) 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

Outcomes

Primary Outcomes

Investigator rated T5SS (Total 5 symptom Score) over 2 weeks

Time frame: 2 weeks

Secondary Outcomes

Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI).

Time frame: 2 weeks

Data from ClinicalTrials.gov

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