Randomized placebo-controlled study comparing a leukotriene receptor antagonist and a nasal glucocorticoid in seasonal allergic rhinitis

Allergic rhinitis is an inflammatory disorder associated with local leukotr iene release during periods of symptoms. Therefore, it has been suggested t hat antileukotrienes may be beneficial in the treatment of this disease. Le ukotriene receptor antagonists have recently become available for asthma tr eatment, but little is known of their effects on allergic rhinitis. We have evaluated the effects of the leukotriene receptor antagonist zafirlukast v ersus placebo in patients with allergic rhinitis during the grass pollen se ason, using the nasal glucocorticoid beclomethasone dipropionate (BDP) as a positive treatment control. Thirty-three patients with seasonal allergic r hinitis were in a double-blind, double-dummy fashion randomized to treatmen ts with oral zafirlukast (20 mg twice a day), intranasal beclomethasone dip ropionate (200 mu g twice a day), or placebo. The treatment was Initiated 3 wk prior to the expected beginning of the grass pollen season. Patients co mpleted a daily symptom-score list for sneezing, rhinorrhea, nasal itch, an d nasal blockage during the 50-d treatment period. Nasal biopsies for quant ification of local tissue eosinophilia (immunohistochemistry; EG2) were tak en 1 mo before initiation of treatment and immediately after the peak of gr ass pollen season. Patients receiving treatment with zafirlukast had degree s of nasal symptoms similar to those in the placebo group, whereas the BDP group had significantly less symptoms compared with both treatments (p = 0. 01 and p = 0.005, respectively). The numbers of activated eosinophils in th e nasal tissue increased significantly during the pollen season in both the zafirlukast and the placebo groups, but not in the BDP group. These result s obtained with a limited number of patients do not support any clinical ef ficacy of regular treatment with an oral antileukotriene in seasonal allerg ic rhinitis but rather favor the use of a nasal glucocorticoid.