Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis

This study has been completed.

First Received: September 4, 2007 Last Updated: March 6, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00524836

Purpose

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.

Condition	Intervention	Phase
Rhinitis Allergic Perennial	Drug: levocetirizine dihydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.

Resource links provided by NLM:

Drug Information available for: Loratadine Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

Total 5 Symptom Score (T5SS) rated by the investigator [ Time Frame: 2 weeks ]

Secondary Outcome Measures:

Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI). [ Time Frame: 2 weeks ]

Enrollment:	71
Study Start Date:	September 2003
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male ore female, 16 to 60 years old (inclusive)
two-year history of allergic rhinitis due to house dust mite

Exclusion Criteria:

An ear, nose or throat (ENT) infection
asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
an associated ENT disease
use of decongestants
nasal or ocular topical treatment
desensitivation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524836

Sponsors and Collaborators

UCB

Investigators

Study Director:

Isabelle Campine

UCB

More Information

No publications provided

Study ID Numbers:	A00349
Study First Received:	September 4, 2007
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00524836 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by UCB:

levocetirizine dihydrochloride
Xyzal tablets

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Rhinitis
Anti-Allergic Agents
Cetirizine
Histamine
Hypersensitivity
Histamine Antagonists
Rhinitis, Allergic, Perennial

Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Levocetirizine
Hypersensitivity, Immediate
Histamine phosphate
Histamine H1 Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Cetirizine
Pharmacologic Actions
Nose Diseases

Hypersensitivity
Histamine Antagonists
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Levocetirizine
Therapeutic Uses
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009