LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis) - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
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

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine

U.S. FDA Resources

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)

Further study details as provided by UCB:

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

Investigators

Study Director:

Krassimir Mitchev, MD, PhD

UCB

More Information

Study ID Numbers:	A00401, EudraCT2004-002823-42, LEADER
Study First Received:	September 8, 2005
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00160589
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:

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

Study placed in the following topic categories:

Pruritus
Otorhinolaryngologic Diseases
Rhinitis
Cetirizine
Desloratadine
Histamine
Hypersensitivity

Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Levocetirizine
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Immune System Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents

Cholinergic Agents
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Therapeutic Uses
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on January 16, 2009