Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma

Abstract

Patients with moderate persistent asthma (n = 523; mean FEV1 77.4%) not fully controlled with inhaled corticosteroids (ICS; 400-1000 microg/day) were randomized to receive either once-daily budesonide/formoterol (160/4.5 microg, two inhalations); or twice-daily budesonide/formoterol (160/4.5 microg, one inhalation); or budesonide (400 microg) once-daily for 12 weeks. Once-daily dosing was administered in the evening and twice-daily dosing was administered in the morning and evening. All patients received twice-daily budesonide (200 microg) during a 2-week run-in. Compared with budesonide alone, change in mean morning and evening peak expiratory flow was greater in the once-daily budesonide/formoterol group (27 and 171 min(-1), respectively; P < 0.001) and twice-daily budesonide/formoterol group (23 and 24 l min(-1), respectively; P < 0.001). Night awakenings, symptom-free days, reliever-use-free days and asthma-control days were all improved during once-daily budesonide/formoterol therapy vs. budesonide (P < or = 0.05). Similar improvements were also seen with twice-daily budesonide/formoterol (P < or = 0.05). The risk of a mild exacerbation was reduced after once- and twice-daily budesonide/formoterol vs. budesonide (38% and 35%, respectively; P < 0.002). All treatments were well tolerated. Budesonide/formoterol, once- or twice-daily, in a single inhaler improved asthma symptoms and exacerbations compared with budesonide. In the majority of patients with moderate persistent asthma requiring ICS and long-acting beta-agonists, once-daily formoterol/budesonide provided sustained efficacy over 24 h, similar to twice-daily dosing.

Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over

“…Three trials were included in this comparison [239][240][241] (Table 56). All of them used parallel-group designs and were published between 2001 and 2006.…”

“…Buhl and colleagues 240 compared two regimens of BUD combined with FF against BUD. In one of the regimens patients took two inhalations (160/4.5 µg) once per day, whereas in the other they inhaled twice per day (160/4.5 µg) (a total daily dose of 320/9 µg).…”

“…Metered doses (ex-actuator) are reported for some arms and delivered doses (ex-valve) for others. This reflects changes in labelling, whereby the combination inhalers (Symbicort Turbuhaler, AZ -not explicitly stated in only one study, 240 but deduced from the text) express doses as delivered, compared with the separate inhalers (BUD: Pulmicort Turbuhaler, AZ -not explicitly stated in any of the three studies, but deduced from the text) for BUD/FF, which express doses as metered. An inhalation of BUD/FF 160/4.5 µg from the combination inhaler delivers the same quantity as a 200-µg metered inhalation of BUD and as a 6-µg metered inhalation of FF.…”

Risk of mortality associated with formoterol: a systematic review and meta-analysis

“…There were nine deaths due to asthma (table 1), and 33 deaths due to other causes, of which 18 were attributed to cardiac causes (table 2) [26,[28][29][30][31][32][33][34][35][36][37][38][39]. Among the patients who died from asthma, five out of the seven patients randomised to formoterol were prescribed ICS (either as randomised or background maintenance therapy), and one out of two patients randomised to non-LABA comparator treatment was prescribed ICS (either as randomised or background maintenance therapy).…”

Asthma management: Are GINA guidelines appropriate for daily clinical practice?

“…[54]. Alternative strategies to lower the C o p y r ig h t G e n e r a l P r a c t ic e A ir w a y s G r o u p R e p r o d u c t io n p r o h ib it e d total daily dose of ICS include the addition of longacting bronchodilators or leukotriene modifiers in people with moderate to severe asthma, but not in those patients with mild persistent asthma [55][56][57][58]. Such new agents and new strategies would potentially reduce both the incidence and fear of adverse events due to ICS -an important consideration in achieving patient adherence.…”