Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

This study has been completed.

First Received: October 10, 2007 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00542607

Purpose

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Fexofenadine Levocetirizine Levocetirizine dihydrochloride Fexofenadine hydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcome Measures:

The change from baseline of the mean MSC score over time interval 3
the change from baseline of the mean MSC score over time intervals 1 and 4.

Enrollment:	94
Study Start Date:	September 2002
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults 18 to 55 years both inclusive
suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
positive RAST and/or positive skin prick test
comply with study restrictions

Exclusion Criteria:

known alcohol or drug addiction or abuse
known allergy/intollerance to lactose, cellullose, cornstarch
presence of nasal anatomical deformities leading to > 50% obstruction
ENT infection within 30 days of the study
use of disallowed medication
ongoing desensitivation
known cardiac, renal or hepatic dysfunction
presenting allergic bronchial asthma
use of cimetidine
intenting to donate blood during the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542607

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:	A00324
Study First Received:	October 10, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00542607 History of Changes
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by UCB, Inc.:

Levocetirizine dihydrochloride
Xyzal tablets

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
Fexofenadine
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010