Effects of adding nedocromil sodium (Tilade) to the routine therapy of patients with bronchial asthma.
In a 12-week double-blind, group comparative trial, preceded by a 2-week baseline period, 38 asthmatic subjects of mixed aetiology and varying severity received either 4 mg nedocromil sodium by metered dose inhaler twice a day or a matching placebo preparation, in addition to their existing maintenance therapy of inhaled corticosteroids plus inhaled bronchodilators. Asthma severity and lung function were assessed at 4-weekly clinic visits, and symptomatology (morning tightness, daytime asthma, cough, night-time asthma), morning, afternoon and evening PEFR, and the use of inhaled bronchodilators were recorded on daily diary cards. Treatment with nedocromil sodium led to significant (P less than 0.05) improvements in clinic assessment of FEV1 and PEFR both before and after an inhaled bronchodilator from at least the eighth week onwards. Mid-study FVC was also significantly (P less than 0.05) improved. Daily PEFR increased throughout the study in the nedocromil sodium-treated subjects and the diurnal variation was reduced. Daily symptom severity was also reduced and these improvements occurred despite the similar or slightly reduced use of inhaled bronchodilators. However, none of these improvements in diary card parameters reached statistical significance. By the final week of the study subjects treated with nedocromil sodium predominantly had a mild form of asthma or no symptoms at all, and both patients and clinicians reported the effectiveness of nedocromil sodium; the subjects but not the clinicians finding it significantly more effective (P less than 0.05) than placebo. Nedocromil sodium was well tolerated although one patient was withdrawn owing to a persistent sore throat after 7 weeks of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)