[Nedocromil sodium therapy in asthma patients. Therapeutic effect in addition to treatment with oral theophylline and inhaled bronchodilator agents]

Abstract

131 asthmatics aged 12-65 years, who still had symptoms despite inhaled or oral bronchodilators, were included in this double-blind group comparative study involving nedocromil sodium (2 puffs of 2 mg each twice daily) and placebo (2 puffs twice daily). The study was carried out at 8 centers over six weeks. Under nedocromil sodium, cough, dyspnea and severity of attacks were reduced significantly. Overall patient assessment also clearly favoured the active substance. Nedocromil sodium was also superior to placebo in terms of the improvement of lung function (FEV1, FVC and PEFR). 26 patients complained of unusual symptoms (12 under nedocromil sodium, 14 under placebo). Nedocromil sodium proved to be an effective, safe and well-tolerated drug in the antiinflammatory long-term treatment of reversible obstructive airways disease.