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

This study has been completed.
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
First received: August 24, 2007
Last updated: December 13, 2013
Last verified: September 2009
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Condition Intervention Phase
Drug: Levocetirizine dihydrochloride
Phase 4

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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

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

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

Enrollment: 453
Study Start Date: September 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00521131

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00521131     History of Changes
Other Study ID Numbers: A00333 
Study First Received: August 24, 2007
Last Updated: December 13, 2013
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

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

ClinicalTrials.gov processed this record on May 25, 2016