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Completed

NCT Number: NCT00621959

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

levocetirizine dihydrochloride

Drug

5mg daily (oral tablet) for 14 days

Other names: Xyzal

Placebo

Drug

0mg (matching oral tablet)for 14 days

Primary outcomes

  1. Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)

    Time frame: Over the total treatment period (14 days)

    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.

Secondary outcomes

  1. Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score

    Time frame: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)

    The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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