A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
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
1 other identifier
interventional
596
1 country
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2008
Shorter than P25 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 6, 2009
CompletedJuly 16, 2020
July 1, 2020
3 months
February 11, 2008
June 18, 2009
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Over the total treatment period (14 days)
Secondary Outcomes (1)
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Study Arms (2)
Placebo
PLACEBO COMPARATORMatched placebo tablets once daily
LCTZ
EXPERIMENTAL5 mg levocetirizine dihydrochloride tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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
- % compliance on run in study medication and 80% compliance on completing the diary
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (26)
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Albany, Georgia, United States
Unknown Facility
Lilburn, Georgia, United States
Unknown Facility
Savannah, Georgia, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Metairie, Louisiana, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
New Braunfels, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
San Angelo, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Waco, Texas, United States
Related Publications (2)
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.
PMID: 20377116DERIVEDMansfield 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.
PMID: 20350147DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 22, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 16, 2020
Results First Posted
August 6, 2009
Record last verified: 2020-07