Safety and effectiveness of budesonide and formoterol fumarate dihydrate in asthma patients 12 years of age and older have been established in studies up to 12 months. In the two 12-week, double-blind, placebo-controlled US pivotal studies 25 patients 12 to 17 years of age were treated with budesonide and formoterol fumarate dihydrate twice daily [see Clinical Studies (14.1)]. Efficacy results in this age group were similar to those observed in patients 18 years and older. There were no obvious differences in the type or frequency of adverse events reported in this age group compared with patients 18 years of age and older. 

The safety and effectiveness of budesonide and formoterol fumarate dihydrate 80/4.5 in asthma patients 6 to less than 12 years of age have been established in studies of up to 12-week duration [see Clinical Studies (14.1)]. The safety profile in these patients was consistent to that observed in patients 12 years of age and older who also received budesonide and formoterol fumarate dihydrate [see Adverse Reactions (6.1)].

The safety and effectiveness of budesonide and formoterol fumarate dihydrate in asthma patients less than 6 years of age have not been established.

Controlled clinical studies have shown that orally inhaled corticosteroids including budesonide, a component of budesonide and formoterol fumarate dihydrate, may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effect of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final height are unknown. The potential for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. 

In a study of asthmatic children 5 to 12 years of age, those treated with budesonide DPI 200 mcg twice daily (n=311) had a 1.1 centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. By the end of 4 years, children treated with budesonide DPI and children treated with placebo had similar growth velocities. Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study. 

The growth of pediatric patients receiving orally inhaled corticosteroids, including budesonide and formoterol fumarate dihydrate, should be monitored. If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including budesonide and formoterol fumarate dihydrate, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see Dosage and Administration (2)].