Study of levocetirizine in seasonal allergic rhinitis

Abstract

In this study, levocetirizine 5 mg QD was well tolerated but failed to show significant efficacy compared with placebo in a US adult population with SAR. This finding is inconsistent with all previous studies with levocetirizine and in contrast to a concurrently run, similarly designed US study. It reflects the importance of conducting duplicate studies as there is always a small but real risk of false negative results in clinical studies, irrespective of the methodologic quality.

Levocetirizine: Review of its Use in the Treatment of Seasonal Allergic Rhinitis

“…44 LCZ was superior to PLA in three studies 40,41,43 and equal in efficacy in one study. 42 RUP was superior to LCZ 46 and addition of LCZ to FLUT therapy was equal to FLUT monotherapy. 44 When all patients (antihistamine naïve or previously-exposed) received LCZ, there was a significant reduction in symptoms with greater satisfaction compared with previous therapy.…”

“…41 In two studies which reviewed effect of LCZ on T5SS, one found T5SS (except nasal congestion) was significantly improved with LCZ along with TNSS and TOSS vs. PLA, 43 whereas the other found nonsignificant reduction in T5SS by LCZ vs. PLA. 42 In the 6-week pediatric study reviewed, 40 LCZ relieved nasal congestion significantly better than PLA only at week 3, but had significant improvement in all T4SS (except ocular pruritus) over 6 weeks.…”

“…64 Eight studies, examining 3230 patients, were included in this review of efficacy and QOL of LCZ in patients with SAR. Four studies compared LCZ with PLA, [40][41][42][43] one study compared LCZ with RUP, 46 one study compared LCZ and DSL with PLA, 33 one study assessed LCZ in patients naïve to or were on previous antihistamine therapy, 45 and another study compared FLUT monotherapy with FLUT + LCZ. 44 LCZ was superior to PLA in three studies 40,41,43 and equal in efficacy in one study.…”

“…33,[40][41][42][43][44][45][46][47][48][49][50] deBlic et al 40 conducted a 6-week, randomized, multicenter, double-blind, placebo-controlled study in 41 centers in France and Germany in 177 children (66.1% males; 90.4% Caucasian; age range 6-13 years). The objective was to evaluate effect of LCZ 5 mg daily on T4SS in first two weeks of treatment.…”

“…Description of the assessments used in efficacy and quality of life studies. 33,[40][41][42][43][44][45][46][47][48][49][50]57 • each of the following rhinoconjunctival symptom is graded on 4-point scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) with scores ranging from 0-15. ○ Total 5 Symptom Score (T5SS: sneezing, rhinorrhea, nasal pruritus, ocular pruritus, and nasal congestion) ○ Total 4 Symptom Score (T4SS: sneezing, rhinorrhea, nasal pruritus, and ocular pruritus) ○ Total Symptom Score (TSS: rhinorrhea, nasal itching, sneezing, and nasal obstruction) ○ Total Nasal Score (TNS: sneezing, runny nose, nasal itching, nasal congestion) ○ Total Nasal Symptom Score (TNSS: of sneezing, rhinorrhea, nasal itching, nasal congestion, and postnasal drip) • QOL assessment tools ○ Juniper Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) ▪ RQLQ contains 7 domains (emotional function, eye symptoms, non-hay fever symptoms, nasal symptoms, practical problems, and sleep problems) with 28 items scored on 7-point scale (0 = not troubled/none of the time to 6 = extremely troubled/all the time) ○ mini-RQLQ ▪ Mini-RQLQ scores similar to RQLQ, but covers 5 domains (activities, practical problems, nose symptoms, eye symptoms, and other symptoms) with total of 14 items ○ Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire (PRQLQ)…”