Effectiveness of various regimens of maintaining anti-inflammatory therapy in mild to moderate asthmatic children: results of the prospective multicenter randomized trial

摘要

Currently advantages and disadvantages of different regimens of maintaining therapy in children with the controlled BA are unknown when the desired level of control over the disease has been achieved with the low doses of ICS.Objective: to compare the effectiveness of transition to nedocromil sodium (NS) and three variants of fluticasone propionate (FP) usage in the dose of 100 mcg / day in children with mild persistent / moderate bronchial asthma (BA) receiving low doses of inhaled corticosteroids (ICS) and achieved criteria of the controlled course of the disease.Materials and Methods: 157 children were chosen to participate in the study, 152 patients were randomized. After a monthly introductory period (FP 125 mcg 2 times / day) patients were randomized into 4 groups to receive drugs for 3 months: NS, FP 50 mcg 2 times / day (FP*50); FP 100 mcg 1 time / day daily (FP* 100); FP 100 mcg 1 time / day 4 days a week (FP* 100A). In the study the patient pays the doctor three more planned visits - after 1, 2, and 3 months after initiation of treatment in the randomized group.Results: Overall asthma control was significantly better for FP50BID but not for FP100QD regimes, as compared to NS. There were significantly fewer symptom-free days and more rescue salbutamol administration in NS, but not in FP groups in 4 wks of treatment. There weren't significant differences between the treatment regimes in asthma control and exacerbations, lung function, and quality of life.Conclusions: Once asthma control is achieved with FP 125 mcg bid (FP125BID) safe "stepping-down" to FP50BID but not to NS or FP100QD may be used to maintain control within the next 12 wks in mild-to-moderate asthmatic children. Cyclical administration of ICS with 3-day breaks is not less efficient than their daily use and may be offered to some patients with mild persistent asthma as an intermediate step to the withdrawal of controller medication if their disease is well controlled by regular treatment with ICS.