A double‐blind, placebo‐controlled comparison of treatment with fluticasone propionate and levocabastine in patients with seasonal allergic rhinitis

Abstract

Fluticasone propionate aqueous nasal spray (FPANS) is a topically active glucocorticoid which has been successfully used for the treatment of seasonal allergic rhinitis (SAR). Topical levocabastine is a highly selective H1 antagonist which has been proposed as an alternative treatment of SAR. The purpose of this study was to compare the clinical efficacy of two topical nasal treatments, FPANS and levocabastine, in the treatment of SAR. Additionally, the effect of treatments on nasal inflammation was examined during natural pollen exposure. A group of 288 adolescent and adult patients with at least a 2-year history of SAR to seasonal pollens participated in a multicenter, doubleblind, double-dummy, and placebo-controlled study. Patients were treated with either FPANS 200 microg, once daily (n = 97), or topical levocabastine, 200 microg, given twice daily (n = 96), or matched placebo (n = 95) for a period of 6 weeks, starting from the expected beginning of the pollen season. Clinically relevant pollens included Parietaria, olive, and grass. Assessment of efficacy was based on scores of daily nasal symptoms and on nasal cytology of nasal lavage. Nasal lavage was performed immediately before, during, and at the end of treatment in 39 patients. FPANS significantly increased the percentage of symptom-free days for nasal obstruction on waking and during the day, rhinorrhea, sneezing, and itching. FPANS provided a better control for night and day nasal obstruction (P<0.02 and P<0.01) and rhinorrhea (P<0.01) than levocabas tine. In addition, fewer patients treated with FPANS used rescue medication (P<0.025). The percentage of eosinophils in nasal lavage was reduced only during treatment with FPANS. The results of this study indicate that FPANS 200 microg, once daily, provides a better clinical effect than levocabastine 200 microg, twice daily, in patients with SAR. Unlike levocabastine, FPANS significantly attenuates nasal eosinophilia during pollen exposure, a feature which may explain its therapeutic efficacy.

Are intranasal corticosteroids all equally consistent in managing ocular symptoms of seasonal allergic rhinitis?

“…The fourth study, Ortolani et al, 1999, investigated the efficacy and safety of FP nasal spray 200 mg once daily, levocabastine 200 mg twice daily, and placebo in 288 patients (aged 13-64 years) with SAR. Efficacy data from this study, as assessed via patient-recorded symptom scores (four-point scale), showed that the median percentage of days without eye symptoms in the FP 200 mg once daily treatment group was not statistically significantly different compared with placebo-treated patients (58.5 days vs. 56.1 days, respectively, p-value not reported) 47 .…”

Evaluation of serum s-IgE/total IgE ratio in predicting clinical response to allergen-specific immunotherapy

“…12,13 The response to ASI was determined clinically by asking the patient the following: ''Do you feel better than you did before therapy?'' The answer could be one of the following:…”

Intranasal Steroids in the Treatment of Allergy-Induced Rhinorrhea

“…INS have been associated with reduced expression of histamine, a number of cytokines, and other inflammatory mediators produced and/or released by mast cells and basophils during the inflammatory cascade, as well as reduced expression of several proinflammatory cells involved in the pathogenesis of AR (lymphocytes, eosinophils, basophils, mast cells, Langerhans cells, and epithelial cells) (Table 3) [29,[34][35][36][37][38][39][40][41][42].…”