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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00521131
First received: August 24, 2007
Last updated: December 13, 2013
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Rhinitis
Allergic
Perennial
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)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

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
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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014