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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: April 1, 2008   Last Updated: December 23, 2009   History of Changes
Sponsor: UCB, Inc.
Information provided by: UCB, Inc.
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

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever Itching
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) Over the Total Treatment Period (14 Days) [ Time Frame: Over the total treatment period (14 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Total 5 Symptoms Score (T5SS) Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Total 5 Symptoms Score (T5SS) Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Total 4 Symptoms Score (T4SS) Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Total 4 Symptoms Score (T4SS) Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS) Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS) Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score (TOSS) Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score (TOSS) Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Sneezing Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Sneezing Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Sneezing Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Rhinorrhea Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Rhinorrhea Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Rhinorrhea Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Nasal Congestion Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Nasal Congestion Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Nasal Congestion Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Nasal Pruritus Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Nasal Pruritus Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Nasal Pruritus Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Post-nasal Drip Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Post-nasal Drip Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Post-nasal Drip Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Ocular Pruritus Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Ocular Pruritus Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Ocular Pruritus Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Ocular Itching/Burning Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Ocular Itching/Burning Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Ocular Tearing/Watering Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Ocular Tearing/Watering Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Ocular Redness Score Over the First Week [ Time Frame: Over week 1 ] [ Designated as safety issue: No ]
  • Ocular Redness Score Over the Second Week [ Time Frame: Over week 2 ] [ Designated as safety issue: No ]
  • Ocular Redness Score Over the Total Treatment Period (14 Days) [ Time Frame: Over total treatment period (14 days) ] [ Designated as safety issue: No ]
  • Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 [ Time Frame: Baseline and week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
  • Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period [ Time Frame: Baseline and at endpoint of the 2 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 580
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
Placebo: Placebo Comparator
Matched placebo tablets
Drug: placebo
0 mg daily (matching oral tablet) for 14 days
LCTZ: Experimental
5 mg tablet
Drug: levocetirizine dihydrochloride
5 mg daily (oral tablet) for 14 days

  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, 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

Responsible Party: UCB ( Study Director )
Study ID Numbers: A00431
Study First Received: April 1, 2008
Results First Received: July 28, 2009
Last Updated: December 23, 2009
ClinicalTrials.gov Identifier: NCT00653224     History of Changes
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:
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 February 08, 2010



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