Effectiveness of nedocromil sodium versus placebo as additions to routine asthma maintenance therapy: a multicentre, double-blind, group comparative trial.

A total of 117 subjects took part in a double-blind, placebo-controlled trial of nedocromil sodium (4 x 4 mg daily by inhalation) in the management of patients with moderately severe bronchial asthma. Treatment was randomly allocated and was continued for 12 weeks following a 2-week baseline period on routine asthma therapy. Statistically significant differences for nedocromil sodium versus placebo were found for diary card asthma severity scores, morning and evening peak flow measurements and daily bronchodilator usage. The clinicians' assessments of asthma severity and global opinions of treatment efficacy were also significantly in favour of nedocromil sodium. Overall, the clinical status of these asthmatic patients was improved by adding nedocromil sodium onto their existing therapy.