A Study Evaluating the Efficacy and Impact on Health-Related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: levocetirizine dihydrochloride (Drug); placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: UCB

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Overall contact:
UCB Clinical Trial Call Center, Phone: 1 877 822 9493

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

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: The primary objective is to compare the efficacy of levocetirizine and placebo as measured by total symptom score

Secondary outcome: Efficacy

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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%

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 Summary of exclusion criteria for participant selection.

UCB Clinical Trial Call Center, Phone: 1 877 822 9493

Scottsdale, Arizona, United States; Recruiting

LITTLE ROCK, Arkansas, United States; Recruiting

HOT SPRINGS, Arkansas, United States; Not yet recruiting

MISSION VIEJO, California, United States; Recruiting

San Diego, California, United States; Not yet recruiting

Huntington Beach, California, United States; Recruiting

Orange, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Vista, California, United States; Recruiting

Port Charlotte, Florida, United States; Recruiting

Albany, Georgia, United States; Recruiting

Savannah, Georgia, United States; Recruiting

Lilburn, Georgia, United States; Recruiting

OWENSBORO, Kentucky, United States; Recruiting

METARIE, Louisiana, United States; Recruiting

Winston-Salem, North Carolina, United States; Recruiting

Tulsa, Oklahoma, United States; Not yet recruiting

Charleston, South Carolina, United States; Recruiting

SPARTANBURG, South Carolina, United States; Not yet recruiting

Simpsonville, South Carolina, United States; Recruiting

Knoxville, Tennessee, United States; Recruiting

Bristol, Tennessee, United States; Recruiting

Dallas, Texas, United States; Recruiting

EL PASO, Texas, United States; Recruiting

San Antonio, Texas, United States; Not yet recruiting

DALLAS, Texas, United States; Recruiting

Austin, Texas, United States; Recruiting

Fort Worth, Texas, United States; Recruiting

Katy, Texas, United States; Recruiting

New Braunfels, Texas, United States; Recruiting

San Angelo, Texas, United States; Recruiting

Waco, Texas, United States; Recruiting

EL Paso, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Plano, Texas, United States; Recruiting

Starting date: March 2008
Ending date: June 2008
Last updated: June 12, 2008