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Budesonide/formoterol inhaler may benefit African-Americans with asthma

A long-term study found budesonide/formoterol pressurized metered-dose inhalers to be safe and effective, and it reduced asthma exacerbation for African-American patients.

Researchers monitored the effects of a budesonide/formoterol inhaler on African-American patients (n=742) in a double blind, yearlong phase 3B safety study. Eligible participants were aged 12 years and older and previously were treated for moderate-to-severe asthma with inhaled corticosteroids.

All patients began using a 320 mcg pressurized metered-dose inhaler (pMDI) of budesonide twice daily. After 2 weeks, the patients were split into two groups: one group (n=365) continued to use the budesonide inhaler twice daily; the other group (n=377) began twice-daily treatments of 320/9 mcg budesonide/formoterol combination inhaler.

Results showed that both treatment methods were well-tolerated, however, the budesonide/formoterol combination inhaler produced lower rates of asthma exacerbation than the budesonide (7.7% vs. 14%; P=.006). The combination inhaler also prolonged the time to patients’ first incidence of asthma exacerbation (P5.018) compared with patients who received budesonide.

Researchers said the most common adverse effects among all patients were headache (8.6%), nasopharyngitis (7.4%), sinusitis (5.1%) and viral upper respiratory tract infection (5.1%).

“Budesonide/formoterol pMDI was well-tolerated over 12 months, with a safety profile similar to that of budesonide,” researchers wrote. “The asthma exacerbation rate was reduced by 38.5% versus budesonide.”

Disclosure: See the study for a full list of relevant disclosures.