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Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

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ClinicalTrials.gov Identifier: NCT00521131
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
Study Start Date : September 2002
Primary Completion Date : May 2003
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Number of comfortable days, as assessed by the subject [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week 1 and over 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female ≥ 12 years
  • suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
  • positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
  • the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion Criteria:

  • seasonal allergic rhinitis likely to change significantly the symptoms of the subject
  • an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
  • asthma requiring corticosteroid treatment
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
  • associated ENT disease

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): NCT00521131


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
ClinicalTrials.gov Identifier: NCT00521131     History of Changes
Other Study ID Numbers: A00333
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents