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Trial record 1 of 1 for:    NCT00621959
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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

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ClinicalTrials.gov Identifier: NCT00621959
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : August 6, 2009
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: levocetirizine dihydrochloride Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
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
Study Start Date : March 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

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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
Metairie, 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
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00621959    
Other Study ID Numbers: A00430
First Posted: February 22, 2008    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by UCB Pharma:
Seasonal Allergic Rhinitis
total symptom score
quality of life
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs