A Study Evaluating the Efficacy and Impact on Health-Related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00621959

Purpose

The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life

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

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Impact on Health-Related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Allergic Rhinitis

Further study details as provided by UCB:

Primary Outcome Measures:

The primary objective is to compare the efficacy of levocetirizine and placebo as measured by total symptom score [ Time Frame: over the total treatment period ]

Secondary Outcome Measures:

Efficacy [ Time Frame: at endpoint, defined as the last available post-baseline observation ]

Enrollment:	596
Study Start Date:	March 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Matched placebo tablets once daily	Drug: placebo matching placebo tablets P.O. once daily
2: Experimental 5 mg tablet	Drug: levocetirizine dihydrochloride Levocetirizine dihydrochloride 5 mg tablets P.O. once daily in the evening

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a history of SAR symptoms
A positive skin prick test at least one grass allergen
Moderate - severe SAR symptoms at baseline
Women of childbearing potential must use a medically acceptable form of contraception
80% compliance on run in study medication and 80%

Exclusion Criteria:

The presence of any clinically significant comorbid disease which may interfere with the study assessments
The presence of renal disease
Pregnant or breastfeeding
Subject is currently participating in another clinical trial
Known hypersensitivity to piperazines or any of the excipients
Intake of medications prohibited before the start of the trial
Subjects who started or changed the dose of immunotherapy
Rhinitis medicamentosa
Subjects with a recent history (within the last 2 years) of drug or alcohol abuse Summary of exclusion criteria for participant selection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621959

Locations

United States, Arizona

Scottsdale, Arizona, United States
United States, Arkansas

LITTLE ROCK, Arkansas, United States

HOT SPRINGS, Arkansas, United States
United States, California

Long Beach, California, United States

Huntington Beach, California, United States

MISSION VIEJO, California, United States

Los Angeles, California, United States
United States, Georgia

Albany, Georgia, United States

Savannah, Georgia, United States

Lilburn, Georgia, United States
United States, Kentucky

OWENSBORO, Kentucky, United States
United States, Louisiana

METARIE, Louisiana, United States
United States, North Carolina

Winston-Salem, North Carolina, United States
United States, Oklahoma

Tulsa, Oklahoma, United States
United States, South Carolina

Charleston, South Carolina, United States
United States, Tennessee

Knoxville, Tennessee, United States
United States, Texas

Dallas, Texas, United States

San Antonio, Texas, United States

DALLAS, Texas, United States

Austin, Texas, United States

Plano, Texas, United States

Katy, Texas, United States

New Braunfels, Texas, United States

San Angelo, Texas, United States

Waco, Texas, United States

EL Paso, Texas, United States

Fort Worth, Texas, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	A00430
Study First Received:	February 11, 2008
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00621959 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

levocetirizine
Xyzal
Seasonal Allergic Rhinitis
total symptom score
quality of life

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Quality of Life
Rhinitis
Anti-Allergic Agents
Cetirizine
Histamine
Hypersensitivity
Histamine Antagonists

Respiratory Tract Diseases
Respiratory Tract Infections
Levocetirizine
Rhinitis, Allergic, Seasonal
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
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 May 06, 2009