A 3-month double-blind group comparative trial of nedocromil sodium (4 mg twice daily) and placebo was carried out in 30 adult asthmatic patients maintained on bronchodilator therapy. Fifteen patients received each treatment. Subjective (asthma symptoms and severity) and objective (lung function and use of concomitant medication) variables were measured to monitor the response to trial treatments. Significant differences in favour of nedocromil sodium for night-time asthma, daytime asthma, cough, daytime bronchodilator use and clinic assessment of forced expiratory volume during the first second of expiration were observed by week 4 of the trial. The diurnal variation in peak expiratory flow rate was reduced in the nedocromil sodium treated patients. There were no serious adverse reactions and no treatment related changes in haematological findings, blood biochemistry or urinalysis.

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