Long-term intervention in childhood asthma: the Dutch study results. Dutch Chronic Nonspecific Lung Disease Study Group

Abstract

In The Netherlands, a long-term multicentre intervention study was performed in asthmatic children, comparing different treatment regimens. The study consists of three integrated parts. Part 1, 116 children randomized to receive either 0.2 mg salbutamol plus 0.2 mg budesonide t.i.d. (steroid group) or 0.2 mg salbutamol plus placebo t.i.d. (placebo group). Endpoints were symptoms, airway calibre, expressed as forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF) before and after bronchodilation, and airway responsiveness (PD20 histamine). Part 2, steroid group follow-up of 28-36 months. The further course of endpoints and the remission (symptom-free during any 8 month period) rate were studied. Part 3, the effect of cessation of long-term administration of inhaled corticosteroid on FEV1 PD20 histamine and symptoms was investigated for 6 months in 28 steroid group children. Randomization (2:1) to either decrease and stop (after 2 months) corticosteroid (cessation group), or to continue treatment (continuous group). Part 1, withdrawals: placebo group 26/58; steroid group 3/58. This part of the study was stopped after a median follow-up period of 22 months. All endpoints improved in the steroid group and PD20 histamine continued to improve and remained unchanged in the placebo group. Part 2, symptoms tended to improve during the whole follow-up period. PD20 histamine plateaued after 22 months at a subnormal level. Thirty five patients (60%) achieved a remission during treatment; 23 (66%) relapsed. Part 3, 8/20 in the cessation group withdrew (symptoms increased, FEV1 and PD20 histamine decreased). In the continuous group no withdrawals occurred (FEV1 and PD20 histamine remained stable).(ABSTRACT TRUNCATED AT 250 WORDS)