A double-blind comparative trial of nedocromil sodium and placebo in the management of bronchial asthma in patients routinely using oral bronchodilators.

The efficacy and tolerability of nedocromil sodium, 4 mg four times daily, were investigated in a 4-week, randomized, placebo-controlled, double-blind trial in 54 asthmatic patients. Significant improvements were seen in the nedocromil sodium treated patients with respect to asthma severity (recorded by patients on diary cards); lung function (assessed by PEFR); daytime and night-time asthma (patients' diary cards), and morning and evening peak flow rates (measured by patients at home). Unusual symptoms were few and of a minor nature, differing little between active and placebo treatment. Nedocromil sodium, at the dosage used in this study, was well tolerated and provided a useful addition to asthma therapy.

RCT Entities:   Population Interventions Outcomes