Long-term Safety and Systemic Effects of Budesonide and Formoterol Administered via One Pressurized Metered-Dose Inhaler (pMDI) in Children With Asthma

Abstract

RationaleTo assess the long-term safety of budesonide/formoterol pMDI in children with persistent asthma.MethodsThis was a 26-week, multicenter, randomized, open-label study (SD-039-0719) of children 6-11 years with asthma requiring treatment with inhaled corticosteroids (ICSs). After 1 week on their usual ICS therapy, patients received twice-daily budesonide/formoterol pMDI 160/4.5μg ×2 inhalations (320/9μg; n = 123) or budesonide DPI 160μg ×2 inhalations (320μg; n = 63). Assessments included AEs and changes from baseline to end of treatment (EOT) in height (cm) and to week 12 and EOT in 24-hour urinary cortisol (nmol/24 h).ResultsThe percentage of patients reporting ≥1 AE was similar with budesonide/formoterol (84.6%) and budesonide (85.7%); most were mild or moderate in intensity. Drug-related AE incidence was low and similar with budesonide/formoterol (4.9%) and budesonide (6.3%). During treatment, 3 patients experienced serious AEs (2/123 in the budesonide/formoterol group [asthma; pneumonia] and 1/63 in the budesonide group [sickle cell anemia]); none were drug-related or led to discontinuation. Two patients in each treatment group experienced AEs leading to discontinuation (DAEs); one in each group was an asthma DAE. No significant differences in changes in height were observed between the budesonide/formoterol (2.51 cm) and budesonide (2.10 cm) groups. Decreases in 24-hour urinary cortisol were numerically, but not significantly, smaller with budesonide/formoterol versus budesonide; the percentage of patients with shifts from baseline normal to low at EOT was small in both groups (4.1% and 7.9%, respectively).ConclusionsIn patients 6-11 years with persistent asthma, budesonide/formoterol pMDI was well tolerated over 26 weeks, with a safety profile similar to budesonide. RationaleTo assess the long-term safety of budesonide/formoterol pMDI in children with persistent asthma. To assess the long-term safety of budesonide/formoterol pMDI in children with persistent asthma. MethodsThis was a 26-week, multicenter, randomized, open-label study (SD-039-0719) of children 6-11 years with asthma requiring treatment with inhaled corticosteroids (ICSs). After 1 week on their usual ICS therapy, patients received twice-daily budesonide/formoterol pMDI 160/4.5μg ×2 inhalations (320/9μg; n = 123) or budesonide DPI 160μg ×2 inhalations (320μg; n = 63). Assessments included AEs and changes from baseline to end of treatment (EOT) in height (cm) and to week 12 and EOT in 24-hour urinary cortisol (nmol/24 h). This was a 26-week, multicenter, randomized, open-label study (SD-039-0719) of children 6-11 years with asthma requiring treatment with inhaled corticosteroids (ICSs). After 1 week on their usual ICS therapy, patients received twice-daily budesonide/formoterol pMDI 160/4.5μg ×2 inhalations (320/9μg; n = 123) or budesonide DPI 160μg ×2 inhalations (320μg; n = 63). Assessments included AEs and changes from baseline to end of treatment (EOT) in height (cm) and to week 12 and EOT in 24-hour urinary cortisol (nmol/24 h). ResultsThe percentage of patients reporting ≥1 AE was similar with budesonide/formoterol (84.6%) and budesonide (85.7%); most were mild or moderate in intensity. Drug-related AE incidence was low and similar with budesonide/formoterol (4.9%) and budesonide (6.3%). During treatment, 3 patients experienced serious AEs (2/123 in the budesonide/formoterol group [asthma; pneumonia] and 1/63 in the budesonide group [sickle cell anemia]); none were drug-related or led to discontinuation. Two patients in each treatment group experienced AEs leading to discontinuation (DAEs); one in each group was an asthma DAE. No significant differences in changes in height were observed between the budesonide/formoterol (2.51 cm) and budesonide (2.10 cm) groups. Decreases in 24-hour urinary cortisol were numerically, but not significantly, smaller with budesonide/formoterol versus budesonide; the percentage of patients with shifts from baseline normal to low at EOT was small in both groups (4.1% and 7.9%, respectively). The percentage of patients reporting ≥1 AE was similar with budesonide/formoterol (84.6%) and budesonide (85.7%); most were mild or moderate in intensity. Drug-related AE incidence was low and similar with budesonide/formoterol (4.9%) and budesonide (6.3%). During treatment, 3 patients experienced serious AEs (2/123 in the budesonide/formoterol group [asthma; pneumonia] and 1/63 in the budesonide group [sickle cell anemia]); none were drug-related or led to discontinuation. Two patients in each treatment group experienced AEs leading to discontinuation (DAEs); one in each group was an asthma DAE. No significant differences in changes in height were observed between the budesonide/formoterol (2.51 cm) and budesonide (2.10 cm) groups. Decreases in 24-hour urinary cortisol were numerically, but not significantly, smaller with budesonide/formoterol versus budesonide; the percentage of patients with shifts from baseline normal to low at EOT was small in both groups (4.1% and 7.9%, respectively). ConclusionsIn patients 6-11 years with persistent asthma, budesonide/formoterol pMDI was well tolerated over 26 weeks, with a safety profile similar to budesonide. In patients 6-11 years with persistent asthma, budesonide/formoterol pMDI was well tolerated over 26 weeks, with a safety profile similar to budesonide.