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LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160589
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
UCB Pharma

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

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Levocetirizine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 729 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : April 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

Secondary Outcome Measures :
  1. Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160589


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00160589    
Other Study ID Numbers: A00401
EudraCT2004-002823-42
LEADER
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Allergic Rhinits, Symptoms (sneezing, rhinorrhea, nasal/ocular pruritus, nasal congestion), LEADER, Xyzal, Levocetirizine
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Levocetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs