A randomised trial of the initiation of asthma treatment

Abstract

Objective: To compare the effectiveness of four classes of anti-asthma medication as initial treatment in a randomised open study in an asthma clinic setting. Design and subjects: Eighty-six patients aged 16-70 years were recruited into an open trial following informed consent. The diagnosis of asthma was established by either a 15% diurnal variability in peak expiratory flow (PEF) or a > 15% bronchodilation to inhaled salbutamol. Patients were randomised to one of the following drug classes: a short-acting β2-agonist (n = 21); an inhaled steroid (n = 25); nedocromil sodium 4 mg qds (n = 22); and oral theophylline (n = 18). Symptoms and daily PEF measurements were recorded on a diary record card. Results: Baseline characteristics of the four groups were similar. Mean FEV1 (predicted) and FVC were 2.61 (82%) and 3.61 (91%), respectively. Wheeze, cough and expectoration were present on 4.2, 3.8 and 2.8 days per week. At one month, the greatest improvement in number of symptom-free days was seen in the group taking the inhaled steroids. Mean days per week with wheeze fell by 1.3 (p < 0.05), cough by 0.5 (NS) and expectoration by 1.5 (p < 0.05). Nedocromil sodium produced a mean decrease in symptom days of 0.8, 0.3 and 0.8, respectively (NS). Other modalities of treatment produced no significant change in symptoms. Mean improvement in FEV1 was greatest in the steroid group (11%; p < 0.02) followed by nedocromil sodium (9%; p < 0.02). There was no change with short-acting β2-agonists or theophylline. Conclusions: Initiation of treatment with antiinflammatory therapy produces the greatest symptomatic and physiological improvement in mild asthma.