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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621959
First Posted: February 22, 2008
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) [ Time Frame: Over the total treatment period (14 days) ]
    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) ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00621959     History of Changes
Other Study ID Numbers: A00430
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: January 15, 2015
Last Verified: January 2015

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

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