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A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
This study has been completed.

First Received on February 11, 2008.   Last Updated on August 30, 2011   History of Changes
Sponsor: UCB, Inc.
Information provided by (Responsible Party): UCB, Inc.
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
Drug Information available for: Levocetirizine Levocetirizine dihydrochloride
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) [ Time Frame: Over the total treatment period (14 days) ] [ Designated as safety issue: No ]
    Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.


Secondary Outcome Measures:
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score [ Time Frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days) ] [ Designated as safety issue: No ]
    The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.


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
Placebo Comparator: Placebo
Matched placebo tablets once daily
 Drug: placebo
0mg (matching oral tablet)for 14 days
Experimental: LCTZ
5 mg levocetirizine dihydrochloride tablet
 Drug: levocetirizine dihydrochloride
5mg daily (oral tablet) for 14 days
Other Name: Xyzal

  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: NCT00621959

Locations
United States, Arizona
Scottsdale, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
United States, Georgia
Albany, Georgia, United States
Lilburn, Georgia, United States
Savannah, 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
Austin, Texas, United States
Dallas, Texas, United States
EL Paso, Texas, United States
Fort Worth, Texas, United States
Katy, Texas, United States
New Braunfels, Texas, United States
Plano, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site
Product Information  This link exits the ClinicalTrials.gov site

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Segall N, Gawchik S, Georges G, Haeusler JM. Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Ann Allergy Asthma Immunol. 2010 Mar;104(3):259-67.
Mansfield LE, Hampel F, Haeusler JM, Georges G. Study of levocetirizine in seasonal allergic rhinitis. Curr Med Res Opin. 2010 Jun;26(6):1269-75.

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00621959     History of Changes
Other Study ID Numbers: A00430
Study First Received: February 11, 2008
Results First Received: June 18, 2009
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
levocetirizine
Xyzal
Seasonal Allergic Rhinitis
total symptom score
quality of life

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Levocetirizine
 Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012



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