A multicenter trial of nedocromil sodium, 1% nasal solution, compared with cromolyn sodium and placebo in ragweed seasonal allergic rhinitis.

This study was a double-blind, parallel-group study to evaluate a new medication, nedocromil sodium, 1%, in comparison with placebo and cromolyn sodium, 4%, for treatment of ragweed seasonal allergic rhinitis. Two hundred thirty-three patients (aged 12 to 65 years) from eight centers were randomized to treatment, one spray per nostril, four times daily, with nedocromil sodium, cromolyn sodium, or matched placebo (80, 76, and 77 patients, respectively). All patients had at least a 2-year history of ragweed seasonal allergic rhinitis. Treatment was for 8 weeks during the ragweed season, and daily pollen counts were used to identify the peak 3-week period. Clinic examinations were made before and after the 1-week baseline and after 1, 3, 5, and 8 weeks of treatment. Rhinitis symptoms were recorded each day by the patients. Nedocromil sodium was more effective than placebo (p less than 0.05) in relieving symptoms as recorded by the patients. Cromolyn sodium was also more effective than placebo, but the difference was not usually significant. Similarly, the active treatments were both better than placebo for clinical parameters measured at visits and for global opinions of treatment, and more rescue therapy was used by the placebo-treated group. There was no significant difference between the two active treatments, but the trend throughout was in favor of nedocromil sodium. Our findings demonstrated nedocromil sodium to be at least as effective as an established therapy (cromolyn sodium) in reducing symptoms of rhinitis during the peak ragweed pollen season.

RCT Entities:   Population Interventions Outcomes