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

This study has been completed.

First Received on August 24, 2007. Last Updated on September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00521131

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 IV

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:

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Number of confortable 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

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

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00521131 History of Changes
Other Study ID Numbers:	A00333
Study First Received:	August 24, 2007
Last Updated:	September 9, 2009
Health Authority:	France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by UCB, Inc.:

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 February 09, 2012