Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis - Full Text View

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

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine Loratadine

U.S. FDA Resources

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.

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

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

Keywords provided by UCB:

levocetirizine dihydrochloride
Xyzal tablets

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Rhinitis
Cetirizine
Histamine
Hypersensitivity
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases

Respiratory Tract Infections
Loratadine
Levocetirizine
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009