LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

This study has been completed.

First Received: September 8, 2005 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00160589

Purpose

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

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: Levocetirizine	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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)

Resource links provided by NLM:

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	729
Study Start Date:	April 2005
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160589

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A00401, EudraCT2004-002823-42, LEADER
Study First Received:	September 8, 2005
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00160589 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health

Keywords provided by UCB, Inc.:

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Cholinergic Agents
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Levocetirizine
Therapeutic Uses
Otorhinolaryngologic Diseases

Immune System Diseases
Histamine Agents
Anti-Allergic Agents
Cetirizine
Desloratadine
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010