The Efficacy and Safety of Nedocromil Sodium 1% Nasal Solution in the Treatment of Ragweed Seasonal Allergic Rhinitis

Abstract

The safety and efficacy of nedocromil sodium 1% nasal solution in the treatment of patients with ragweed seasonal allergic rhinitis was assessed in a double-blind group-comparative study. After a 1-week baseline period that coincided with the start of the ragweed season, patients were randomized to receive either nedocromil sodium 1% nasal solution or matched placebo (1 spray per nostril q.i.d.) for 8 weeks. The primary efficacy variable was the mean daily diary card symptom score for the 3-week peak pollen period. During this time, patients treated with nedocromil sodium showed a significant decrease in sneezing, runny nose symptoms, and sleep disturbances compared with the placebo group. Furthermore, the patient's and physician's assessments of the drug efficacy showed significant differences favoring the nedocromil sodium treatment. No serious adverse experiences were reported during the study. Both groups reported transient minor adverse experiences including sneezing and nasal irritation. Nedocromil sodium was effective in relieving symptoms associated with seasonal allergic rhinitis during peak ragweed seasonal challenge without significant adverse effects.