Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects

This study has been completed.

First Received: October 15, 2007 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00544388

Purpose

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

Condition	Intervention	Phase
Rhinitis, Allergic, Seasonal	Drug: levocetirizine dihydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Cetirizine Cetirizine hydrochloride Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary Outcome Measures:

Mean change from baseline in MSC score over each 2-hour interval.

Enrollment:	570
Study Start Date:	April 2004
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male/Female, aged >= 16 years
seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
documented seasonal allergy to ragweed pollen
total symptom score of at least 18 points.

Exclusion Criteria:

nasal anatomic deformities ? 50% obstruction
acute sinusitus within 30 days of Period 2
initiatedor advanced an immunotherapy regimen
immunotherapy injections within 48 hours of pollen exposure
impaired hepatic function
history of malignancy
intolerance to histamines
astma requiring medication more than occasional

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544388

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A00379
Study First Received:	October 15, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00544388 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by UCB, Inc.:

Levocetirizine dihydrochloride
Xyzal tablet

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

ClinicalTrials.gov processed this record on February 08, 2010