Formoterol Plus Low-Dose Budesonide May Improve Asthma Control

Laurie Barclay, MD

December 31, 2008

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December 31, 2008 — Adding formoterol to low-dose budesonide treatment is more likely to be associated with well-controlled asthma vs a large increase in the dose of an inhaled corticosteroid (ICS), according to the results of a study reported in the December issue of Chest.

"Combination therapy with...ICSs and long-acting beta 2-agonists (LABAs), or treatment with high doses of ICSs alone improves asthma control when therapy with low-dose ICSs is not sufficient," write Paul M. O'Byrne, MB, FCCP, from McMaster University in Hamilton, Ontario, Canada, and colleagues. "However, it is not known which of these treatment options is more effective in sustaining asthma control."

The goal of this post hoc analysis was to compare the effect of increasing the ICS dosage vs adding long-acting beta2-agonists on the time spent with well-controlled or poorly controlled asthma. The Formoterol and Corticosteroid Establishing Therapy study compared the effects of a 4-fold increase in the budesonide dose with and without formoterol.

Adding formoterol, 24 µg/day, to therapy with budesonide, 200 µg/day, improved time with well-controlled asthma by 19% (95% confidence interval [CI], 3% - 35%; P = .017). Therapy with budesonide, 800 µg/day, alone improved time with well-controlled asthma by only 2% (95% CI, 9% to 12%), and this was not statistically significant (P = .76). By adding formoterol to therapy with budesonide, 800 µg/day, time with well-controlled asthma was further improved by 29% (95% CI, 13% - 47%; P < .001).

With use of the same interventions, time with poorly controlled asthma was significantly reduced by 43% (95% CI, 25% - 57%), 22% (95% CI, 7% - 44%), and 50% (95% CI, 30% - 64%), respectively. When compared with increasing the budesonide dose 4-fold, adding formoterol to budesonide was significantly more effective in increasing time with well-controlled asthma (increase, 16%; 95% CI, 1% - 33%; P = .035), with a trend toward a greater reduction in time with poor control (decrease, 21%; 95% CI, 5% to 42%).

"The addition of formoterol to therapy with low-dose budesonide increases the probability of well-controlled asthma compared to a substantial increase in the dose of an ICS," the study authors write. "This analysis demonstrates no benefit for increasing the ICS doses alone in achieving well-controlled asthma, although reductions in exacerbations and time with poor control were observed."

Limitations of this study include lack of a formoterol therapy–alone treatment group and inability to determine compliance.

"These findings support the early use of combination therapy when low doses of an ICS are not sufficient, in an effort to establish optimal asthma control," the study authors conclude.

AstraZeneca, the maker of formoterol and budesonide, supported the Formoterol and Corticosteroid Establishing Therapy study, employs 2 of the study authors, and has disclosed financial relationships with 3 other study authors.

Chest. 2008;134:1192-1199.

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