The acceptability, tolerability and safety of nedocromil sodium in long-term clinical use

The safety and efficacy of nedocromil sodium 4 mg four times daily, when added to routine therapy, in the long-term treatment of asthma was investigated in an open study of 55 patients over a 12-month period. The patients recorded pulmonary function (PEFR, morning and evening), use of concomitant medication and severity of asthma on daily diary cards. At 4-weekly clinic visits a full physical examination was made. The use of concomitant medication (oral bronchodilators) was significantly reduced (p < 0.001) compared with baseline levels from month 4 to the end of treatment. Pulmonary function was improved from month 1 and this improvement continued throughout the treatment period. Symptom scores improved from month 3 onwards, an improvement which continued to the end of the trial. Nedocromil sodium was well tolerated by most patients and no serious adverse effects were seen.