Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
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

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

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

Further study details as provided by UCB:

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

Investigators

Study Director:

Marie-Etienne Pinelli, MD

UCB

More Information

Study ID Numbers:	A00324
Study First Received:	October 10, 2007
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00542607
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by UCB:

Levocetirizine dihydrochloride
Xyzal tablets

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Rhinitis
Cetirizine
Histamine
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

Levocetirizine
Rhinitis, Allergic, Seasonal
Fexofenadine
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 15, 2009