LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

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

Completed

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Key information

Conditions

Rhinitis, Allergic, Perennial Airway Obstruction Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinorrhea Signs and Symptoms Signs and Symptoms, Respiratory Sneezing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Levocetirizine

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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)

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Sep 12, 2005
Registry last updated: Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed