A double-blind multicenter group comparative study of the efficacy and safety of nedocromil sodium in the management of asthma

To determine the efficacy of nedocromil sodium in adult asthma patients using bronchodilators alone to control their disease, a consecutive sample of 127 patients with long-term asthma was studied for 16 weeks. The patients were maintained on sustained release theophylline preparations (SRT) and inhaled and oral beta-adrenergic bronchodilators (β₂). One hundred sixteen patients (90 percent) completed the study; one placebo-treated patient withdrew owing to throat irradiation and wheezing. Nedocromil sodium provided an additional benefit to adult patients receiving SRT and inhaled β₂-agonists. With the exception of night-time asthma, nedocromil sodium maintained this improvement for the final 12 weeks of the study despite a reduction in concomitant bronchodilator therapy.