PMID- 20350147
OWN - NLM
STAT- MEDLINE
DCOM- 20100908
LR  - 20140730
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 6
DP  - 2010 Jun
TI  - Study of levocetirizine in seasonal allergic rhinitis.
PG  - 1269-75
LID - 10.1185/03007991003745233 [doi]
AB  - OBJECTIVE: To evaluate the efficacy of levocetirizine 5 mg once daily in reducing 
      seasonal allergic rhinitis (SAR) symptoms in US adults. RESEARCH DESIGN AND 
      METHODS: This multicenter, randomized, double-blind, placebo-controlled, 
      parallel-group study enrolled adults aged 18 to 65 years with SAR symptoms in the 
      spring in the US. After a single-blind placebo run-in period, subjects received 
      levocetirizine 5 mg or placebo once daily over 14 days. ClinicalTrials.gov 
      registry no.: NCT00621959. MAIN OUTCOME MEASURES: Primary efficacy variable was 
      the Total 5-Symptom Score (T5SS). Secondary variables included 
      Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Work Productivity and 
      Activity Impairment-Allergy Specific (WPAI-AS) questionnaire, and Epworth 
      Sleepiness Scale (ESS). Safety assessments were based on adverse events (AEs). 
      RESULTS: The intent-to-treat population comprised 596 subjects (levocetirizine, n 
      = 301; placebo, n = 295). Comparison of mean T5SS over the total treatment period 
      showed a nonsignificant between-group difference (levocetirizine, 8.90 +/- 0.19; 
      placebo, 9.04 +/- 0.19; adjusted mean difference, -0.14; p = 0.546). 
      Levocetirizine showed numerical (mean RQLQ, WPAI-AS, ESS) and statistically 
      superior differences (two domains within WPAI-AS) compared with placebo upon 
      analysis of secondary efficacy variables. The incidence of treatment-emergent AEs 
      was similar (levocetirizine, 23.9%; placebo, 24.4%). As the lack of efficacy was 
      inconsistent with all previous levocetirizine studies, post hoc analyses were 
      performed to assess the influence of pollen counts, geography, and other factors; 
      however, no conclusive explanation could be identified. CONCLUSIONS: 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.
FAU - Mansfield, Lyndon E
AU  - Mansfield LE
AD  - Texas Tech University School of Medicine, El Paso, TX 79905, USA. 
      immunman@gmail.com
FAU - Hampel, Frank
AU  - Hampel F
FAU - Haeusler, Jean-Marc C
AU  - Haeusler JM
FAU - Georges, George
AU  - Georges G
LA  - eng
SI  - ClinicalTrials.gov/NCT00621959
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Histamine H1 Antagonists, Non-Sedating)
RN  - 6U5EA9RT2O (levocetirizine)
RN  - YO7261ME24 (Cetirizine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cetirizine/pharmacology/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Histamine H1 Antagonists, Non-Sedating/pharmacology/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Rhinitis, Allergic, Seasonal/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/03/31 06:00
MHDA- 2010/09/09 06:00
CRDT- 2010/03/31 06:00
PHST- 2010/03/31 06:00 [entrez]
PHST- 2010/03/31 06:00 [pubmed]
PHST- 2010/09/09 06:00 [medline]
AID - 10.1185/03007991003745233 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 Jun;26(6):1269-75. doi: 10.1185/03007991003745233.