Combination Therapy Safe, Effective for Patients with Asthma

A recent FDA-mandated study suggests that a combination therapy is safe and effective in treating patients with moderate-to-severe asthma.

Investigators did not find any increased risk of serious adverse events in patients taking a combination of a long-acting beta antagonist, formoterol, and an inhaled glucorticoid, budesonide.

“A large number of studies have shown that this type of combination therapy really helps asthma control and decreases symptoms,” said lead author of the study Stephen Peters, MD, PhD. “Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients.”

In a study published by the New England Journal of Medicine, investigators examined whether adding formoterol to budesonide maintenance therapy increased asthma-related adverse events. Included in the study were 11,693 patients age 12 or older with persistent asthma, who received daily treatment.

Patients included also had 1 to 4 exacerbations in the previous 12 months. Asthma-related exacerbations are typically caused by inflammatory eosinophil cells recruited to the lungs during an allergic reaction, which then participates in the reaction.

Investigators found that 43 patients receiving the combination therapy, and 40 patients receiving budesonide monotherapy had an asthma-related event during the study period. There were 2 patients receiving the combination therapy who died during the study, compared with none from the other group; however, this finding was not statistically significant.

They also found a 16.5% decrease in exacerbations among patients receiving the combination therapy compared with patients receiving the monotherapy, according to secondary findings.

Investigators concluded the combination therapy with budesonide with formoterol lowered the risk of asthma exacerbations compared with budesonide monotherapy, while having a similar risk of asthma-related events.