LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

This study has been completed.

First Received on September 8, 2005. Last Updated on 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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
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: Desloratadine 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00160589 History of Changes
Other Study ID Numbers:	A00401, EudraCT2004-002823-42, LEADER
Study First Received:	September 8, 2005
Last Updated:	September 9, 2009
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:

Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Levocetirizine
Cetirizine

Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012