Nedocromil sodium and placebo in the treatment of bronchial asthma. A multicenter, double-blind, parallel-group comparison.

Abstract

The efficacy of nedocromil sodium (4 mg twice daily by inhalation) in treating bronchial asthma was assessed by double-blind, placebo-controlled group comparison in 69 adults from three centers. The patients (34 active, 35 placebo) had a history of bronchial asthma with at least 15 percent reversibility. Inhaled corticosteroids, used by 22 and 24 subjects in the active and placebo groups respectively, were discontinued before the study, in which a two-week baseline was followed by six weeks of treatment. Two-weekly clinic assessments of lung function, symptoms and final opinions of treatment were significantly (p less than 0.05 p less than 0.001) in favor of nedocromil sodium. Daily diary cards showed a similar trend with significant drug effects seen after the third week. Blood and urine samples showed no abnormalities and the majority of patient withdrawals (five from nedocromil sodium and six from placebo treatment) were due to worsening asthma. Overall, we found nedocromil sodium to be well tolerated and effective in the management of bronchial asthma.