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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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levocetirizine dihydrochloride
placebo
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

LCTZ

Arm Description

Matched placebo tablets once daily

5 mg levocetirizine dihydrochloride tablet

Outcomes

Primary Outcome Measures

Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
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
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.

Full Information

First Posted
February 11, 2008
Last Updated
July 15, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00621959
Brief Title
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
levocetirizine, Xyzal, Seasonal Allergic Rhinitis, total symptom score, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo tablets once daily
Arm Title
LCTZ
Arm Type
Experimental
Arm Description
5 mg levocetirizine dihydrochloride tablet
Intervention Type
Drug
Intervention Name(s)
levocetirizine dihydrochloride
Other Intervention Name(s)
Xyzal
Intervention Description
5mg daily (oral tablet) for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
0mg (matching oral tablet)for 14 days
Primary Outcome Measure Information:
Title
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
Description
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.
Time Frame
Over the total treatment period (14 days)
Secondary Outcome Measure Information:
Title
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
Description
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.
Time Frame
Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Mission Viejo
State/Province
California
Country
United States
City
Albany
State/Province
Georgia
Country
United States
City
Lilburn
State/Province
Georgia
Country
United States
City
Savannah
State/Province
Georgia
Country
United States
City
Owensboro
State/Province
Kentucky
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
New Braunfels
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Angelo
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Waco
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20377116
Citation
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. doi: 10.1016/j.anai.2009.12.003.
Results Reference
derived
PubMed Identifier
20350147
Citation
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. doi: 10.1185/03007991003745233.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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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