COMPARISON OF NEDOCROMIL SODIUM AT 2 DOSAGE FREQUENCIES WITH PLACEBO IN THE MANAGEMENT OF CHRONIC ASTHMA

Nedocromil sodium (4 mg b.d. or q.i.d.) was added to the therapy of 76chronic asthmatic patients in a four-centre, double-blind cross- over,placebo-controlled trial. Patients had troublesome symptoms uncontrolled by high doses of inhaled corticosteroids (mean 1450 μg). In 54 patients who completed the study, nedocromil sodium was significantly more efficacious than placebo (P < 0·01) in relieving morning chest-tightness and cough, in reducing total diary card score and nocturnal bronchodilator usage, and in increasing morning and evening peak flow. Asthma severity at clinic visits decreased significantly (P=0·001) following treatment with nedocromil sodium, which was globally rated more effective than placebo (P<0·01). Treatment differences favoured q.i.d. over b.d. dosage but without statistical significance. There were no serious adverse effects. Although the pulmonary function changes were small, these findings suggest that the addition of nedocromil sodium may benefit asthmatic patients who are inadequately controlled by high doses of inhaled corticosteroids. © 1992, Baillière Tindall All rights reserved. All rights reserved.