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

UCB

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: placebo; Drug: levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653224

A00431

Details and patient eligibility

About

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.

Enrollment: 580 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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580 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matched placebo tablets

Treatment:

Drug: placebo

LCTZ

Experimental group

Description:

5 mg tablet

Treatment:

Drug: levocetirizine dihydrochloride