Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: A randomized controlled trial

The Journal of Allergy and Clinical Immunology, 04/30/2012

Brown RW et al. – Pulmonary function and asthma control measures generally favored budesonide/formoterol. In this population budesonide/formoterol pressurized metered–dose inhaler (pMDI) was well tolerated over 12months, with a safety profile similar to that of budesonide; the asthma exacerbation rate was reduced by 38.5% versus budesonide.


  • This 52-week, randomized, double-blind, parallel-group, multicenter, phase 3B safety study (NCT00419952) was conducted in 742 self-reported African American patients 12 years or older with moderate-to-severe asthma previously receiving medium- to high-dose inhaled corticosteroids.
  • After 2 weeks using a 320 μg twice-daily budesonide pMDI, patients were randomized 1:1 to 320/9 μg twice-daily budesonide/formoterol pMDI or 320 μg twice-daily budesonide pMDI.


  • Both treatments were well tolerated.
  • Asthma exacerbation incidence and rate (per patient-treatment year) were lower with budesonide/formoterol versus budesonide (incidence, 7.7% vs 14.0% [P = .006]; rate ratio, 0.615 [P = .002]).
  • Time to first asthma exacerbation was longer (P = .018) with budesonide/formoterol versus budesonide.
  • The most common adverse events, regardless of study drug relationship, were headache (9.5% and 7.7%), nasopharyngitis (6.9% and 8.0%), sinusitis (4.0% and 6.3%), and viral upper respiratory tract infection (5.8% and 4.4%) for budesonide/formoterol and budesonide, respectively.
  • Serious adverse events occurred in 12 and 15 patients, respectively; none were considered drug related.
  • No substantial or unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments.
  • Hospitalization caused by asthma exacerbation occurred in 0 and 4 patients in the budesonide/formoterol and budesonide groups, respectively.
  • Pulmonary function and asthma control measures generally favored budesonide/formoterol.

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