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 (Drug)

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-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: The key secondary objective is to compare the effects of levocetirizine and placebo on rhinitis-related QoL

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% 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

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

Tucson, Arizona, United States; Recruiting

Bakersfield, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Sacramento, California, United States; Recruiting

San Diego, California, United States; Recruiting

San Francisco, California, United States; Recruiting

San Jose, California, United States; Recruiting

Denver, Colorado, United States; Recruiting

Colorado Springs, Colorado, United States; Recruiting

Miami, Florida, United States; Recruiting

Miami Beach, Florida, United States; Recruiting

Ocala, Florida, United States; Recruiting

Stockbridge, Georgia, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Gainesville, Georgia, United States; Recruiting

Lawrenceville, Georgia, United States; Recruiting

Normal, Illinois, United States; Recruiting

Louisville, Kentucky, United States; Recruiting

Harvard, Massachusetts, United States; Recruiting

North Dartmouth, Massachusetts, United States; Recruiting

Novi, Michigan, United States; Recruiting

Minneapolis, Minnesota, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Berlin, New Jersey, United States; Recruiting

Skillman, New Jersey, United States; Recruiting

Verona, New Jersey, United States; Recruiting

Rochester, New York, United States; Recruiting

Asheville, North Carolina, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Wilmington, North Carolina, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Edmond, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Portland, Oregon, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Upland, Pennsylvania, United States; Recruiting

Lincoln, Rhode Island, United States; Recruiting

Germantown, Tennessee, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

South Burlington, Vermont, United States; Recruiting

Arlington, Virginia, United States; Recruiting

Seattle, Washington, United States; Recruiting

Milwaukee, Wisconsin, United States; Recruiting

Starting date: April 2008
Ending date: July 2008
Last updated: June 12, 2008