Effects of levocetirizine as add-on therapy to fluticasone in seasonal allergic rhinitis.
BACKGROUND
Addition of H(1) antagonists to intranasal corticosteroid treatment of allergic rhinitis (AR) is common in clinical practice and recommended by guidelines, despite some evidence that the additive benefits are negligible.


OBJECTIVE
To assess additional benefits of 5 mg levocetirizine dihydrochloride in seasonal AR patients using 200 mcg fluticasone propionate nasal spray once daily.


METHODS
In a double-blind placebo-controlled crossover study of 27 patients, following 2 weeks without treatment, subjects used fluticasone with levocetirizine or identical placebo for 2 weeks each. Assessments were the Juniper mini Rhinoconjunctivitis Quality-of-Life Questionnaire (mini-RQLQ), domiciliary peak nasal inspiratory flow (PNIF), total nasal symptoms (TNS) scores and nasal nitric oxide concentrations. Effects were interpreted and tested against minimal clinically important differences.


RESULTS
Add-on effects for levocetirizine vs. placebo excluded any clinically significant benefits: mean effects (one sided 95% confidence intervals) were mini-RQLQ -0.11 (-0.34), PNIF +0.57 (+5.23), and TNS -0.11 (-0.60). Numbers needed to treat (95% confidence intervals) by outcome were mini-RQLQ 14 (5 to 49), PNIF 4 (3-7), and TNS 3 (2-6). No significant within or between treatment effects were seen for nasal nitric oxide.


CONCLUSIONS
Contrary to current practice, the present results demonstrate that for the majority of patients, antihistamine add-on to effective nasal steroid treatment is inappropriate. Further work is required to confirm that this is also true in the most severe cases, and the available evidence needs to be put into guidelines and implemented.
Barnes
M L
ML
Asthma & Allergy Research Group, Department of Medicine and Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, UK.
Ward
J H
JH
Fardon
T C
TC
Lipworth
B J
BJ
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D017332:Cetirizine / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004804:Eosinophils / Q000737:chemistry; D005260:Female; D000068298:Fluticasone; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage*; D006801:Humans; D001239:Inhalation / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000032:analysis; D009666:Nose / Q000503:physiopathology; D010879:Piperazines / Q000008:administration & dosage*; D011058:Pollen / Q000276:immunology; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
D000730:Androstadienes; D018926:Anti-Allergic Agents; D039563:Histamine H1 Antagonists, Non-Sedating; D010879:Piperazines; D009569:Nitric Oxide; C472067:levocetirizine; D000068298:Fluticasone; D017332:Cetirizine