Efficacy and tolerability of nedocromil sodium versus placebo in chronic reversible obstructive airways disease

Abstract

In this 8-week, double-blind, comparative trial of nedocromil sodium (4 mg q.i.d.) versus placebo in 42 patients with chronic reversible obstructive airways disease, there was a trend in favor of nedocromil sodium compared to placebo in parameters assessed by patients (nocturnal symptom scores, evening PEFR values) and those assessed by clinicians (asthma severity scores) compared with baseline values. There was a statistically significant difference (p < 0.05) in favor of nedocromil sodium in the inhaled bronchodilator requirements in the last 2 weeks of treatment. Both patients' and clinicians' evaluation of the overall efficacy of treatment was significant in favor of nedocromil sodium (p < 0.01 and p < 0.05, respectively). The treatments were well tolerated by the majority of patients. From these data, it can be concluded that nedocromil sodium (4 mg q.i.d.) is of value in the preventive treatment of chronic reversible obstructive airways disease.