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

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: placebo; Drug: levocetirizine dihydrochloride

• Registration Number: NCT00621959
• Lead Sponsor: UCB Pharma

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Study Start: 2008-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-06-18
• Results First Submitted QC: 2009-06-18
• Results First Posted: 2009-08-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matched placebo tablets once daily
LCTZ	levocetirizine dihydrochloride	5 mg levocetirizine dihydrochloride tablet

Primary Outcome Measures

Name	Time	Method
Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)	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 Outcome Measures

Name	Time	Method
Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score	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.