Overview

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

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma
Treatments:
Cetirizine
Levocetirizine
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