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:	NCT00653224

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 dihydrochloride Levocetirizine

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-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:

The key secondary objective is to compare the effects of levocetirizine and placebo on rhinitis-related QoL [ Time Frame: at endpoint, defined as the last available post-baseline observation ]

Estimated Enrollment:	278
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Matched placebo tablets	Drug: placebo matching placebo tablet, taken orally, once daily
2: Experimental 5 mg tablet	Drug: levocetirizine dihydrochloride 5 mg tablet, P.O. , once daily

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% compliance on completing the diary

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653224

Show 38 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	A00431
Study First Received:	April 1, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00653224
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:

Otorhinolaryngologic Diseases
Quality of Life
Rhinitis
Cetirizine
Histamine
Hypersensitivity
Respiratory Tract Diseases

Respiratory Tract Infections
Levocetirizine
Rhinitis, Allergic, Seasonal
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 16, 2009