The study was funded by a departmental grant from the asthma and allergy research group and received no financial support from the pharmaceutical industry.
Effects of levocetirizine as add-on therapy to fluticasone in seasonal allergic rhinitis
Article first published online: 26 APR 2006
Clinical & Experimental Allergy
Volume 36, Issue 5, pages 676–684, May 2006
How to Cite
Barnes, M. L., Ward, J. H., Fardon, T. C. and Lipworth, B. J. (2006), Effects of levocetirizine as add-on therapy to fluticasone in seasonal allergic rhinitis. Clinical & Experimental Allergy, 36: 676–684. doi: 10.1111/j.1365-2222.2006.02478.x
- Issue published online: 26 APR 2006
- Article first published online: 26 APR 2006
- Submitted 19 August 2005; revised 6 January 2006; accepted 27 January 2006
- clinical relevance;
- fluticasone propionate;
- levocetirizine dihydrochloride;
- minimal clinically important difference;
- seasonal allergic rhinitis
Background Addition of H1 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.
Conclusion 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.