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Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma
Nemr S Eid1, Michael J Noonan, Bradley Chipps
1Pediatric Pulmonary Medicine, Childhood Asthma Care and Education Center, 571 S Floyd St, Suite 414, Louisville, KY 40202, USA. nseid@louisville.edu
Objective:
To assess efficacy/tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide pMDI (primary) and twice-daily budesonide/formoterol (secondary) in children/adolescents with asthma stabilized with twice-daily budesonide/formoterol.
Methods:
This 12-week multicenter, double-blind randomized controlled study (www.clinicaltrials.gov identifier NCT00646321) included 521 patients aged 6 to 15 years with mild/moderate persistent asthma. Patients stabilized during a 4- to 5-week run-in with twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily) received twice-daily budesonide/formoterol pMDI 40/4.5 microgx2 inhalations (160/18 microg daily), once-daily budesonide/formoterol pMDI 80/4.5 microgx2 inhalations (160/9 microg daily; evening), or once-daily budesonide pMDI 80 microgx2 inhalations (160 microg daily; evening).
Results:
Once- or twice-daily budesonide/formoterol was more effective than budesonide for evening peak expiratory flow (primary variable) at the end of the 24-hour once-daily dosing interval (P
Conclusions:
Once-daily budesonide/formoterol demonstrated significantly better efficacy than once-daily budesonide for most pulmonary-function variables. Twice-daily budesonide/formoterol (160/18 microg daily) maintenance therapy was generally more effective than stepping down to once-daily dosing (160/9 microg daily). Treatments were well tolerated, and there was no evident safety benefit for once- versus twice-daily dosing.
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