Phase 4 N=596 Randomized Quadruple-blind Treatment

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

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT00621959 ↗

Enrolled (actual)

596

Serious AEs

0.3%

Results posted

Aug 2009

Primary outcome: Primary: Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) — 8.96; 8.77 points on a scale — p=0.546

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: levocetirizine dihydrochloride (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB Pharma
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)	8.96; 8.77	0.546
SECONDARY Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score	-1.07; -1.12	0.442

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00621959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.