A trial comparing nedocromil sodium (Tilade) and placebo in the management of bronchial asthma

Abstract

In a double-blind group comparative trial nedocromil sodium (Tilade) at a dose of 4 mg four times daily was compared with placebo in the management of out-patients with bronchial asthma. Treatments were delivered by pressurized aerosol over a period of 28 days following a 2-week base-line during which patients continued on their usual therapy. Twenty-one patients entered the nedocromil sodium group and twenty entered the placebo group. All were using beclomethasone dipropionate aerosol as maintenance steroid therapy plus intermittent use of a bronchodilator taken by inhalation. The dose of steroid was reduced for all patients after 2 weeks of treatment and again for approximately half the patients after 3 weeks trial treatment. Patients in the nedocromil sodium treatment group improved in respect of Diary Card symptom scores and peak expiratory flow rate (PEFR), and in their requirements for inhaled bronchodilators. Patients in the placebo group were worse, particularly in respect of daytime asthma symptoms (P less than 0.01), bronchodilator use (P less than 0.05) and morning PEFR during the third week of trial treatment (P less than 0.05). More patients in the nedocromil sodium group than in the placebo group thought their treatment had been effective (P less than 0.05). Nedocromil was well tolerated. Despite the short duration of treatment imposed at this stage in the clinical evaluation of a new compound, our results were sufficiently encouraging to prompt further evaluation of nedocromil sodium over the longer period required (3-12 months) for the clinical assessment of a new treatment for chronic asthma.