Double-blind crossover study of nedocromil sodium in partially reversible chronic obstructive airways disease.

Abstract

The efficacy of 8 weeks of treatment with 4 mg of nedocromil sodium 4 times daily in the management of partially reversible chronic airflow obstruction was evaluated in a randomized, double-blind, placebo-controlled crossover trial at Repatriation General Hospital, Western Australia. Sixty-seven patients with a mean forced expiratory volume in 1 s (FEV1) of 0.99 L, which improved by 21.8 percent after beta 2-adrenergic bronchodilator, took part in the full 24-week study. After a 4-week run-in period, in addition to their regular therapy comprised of inhaled or oral bronchodilators and steroids (which remained unchanged), patients were randomly allocated to receive treatment with nedocromil sodium or placebo for 8 weeks. This was followed by a 4-week washout, and then the patients were given the alternative test treatment to that given in the first period for another 8 weeks. Compared with placebo, patients receiving nedocromil sodium had improvement in their morning and evening peak flow rates, symptom scores for cough, sleep disturbance, and overall treatment efficacy. Hence, treatment with nedocromil sodium should be considered for patients with partially reversible chronic airflow obstruction not fully controlled with bronchodilators and steroids.