A placebo-controlled, blind comparison of nedocromil sodium and beclomethasone dipropionate in bronchial asthma

Abstract

A multi-centre, randomized, blind comparative group study was carried out in 202 adult patients, who had suffered from asthma for at least 2 years, to assess the effectiveness and tolerability of maintenance treatment with either 4 mg nedocromil sodium 4-times daily, 0.1 mg beclomethasone dipropionate 4-times daily or 2 puffs of placebo 4-times daily, given by inhalation. Lung function (FEV1 and sRaw) measurements were made at the beginning and end of a 2-week baseline period and then after 3 and 6 weeks of treatment: assessment were also made of asthma severity. Patients recorded daily on diary cards details of morning and evening PEFR, usage of inhaled bronchodilators, severity of dyspnoea, cough and morning tightness. The results showed that, compared with placebo, both nedocromil sodium and beclomethasone dipropionate-treated patients showed an improvement in FEV1 and a reduction in sRaw values: PEFR increased slightly in all three groups. There was an improvement in asthma severity, diminished rate of dyspnoea and cough, and reduced usage of inhaled bronchodilators in patients receiving active treatment but not in those on placebo. Overall assessment of treatment efficacy by both investigators and patients showed that opinions were significantly in favour of active treatment over placebo. Treatment was well tolerated and no serious side-effects were reported. It was concluded that at the dosages used nedocromil sodium was comparable with and equivalent to inhaled beclomethasone dipropionate in nearly all of the parameters assessed, and both drugs were superior to placebo in the maintenance treatment of asthma in adult patients.