title: Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients: a randomized controlled trial.
abstract: BACKGROUND
  Information surrounding the long-term safety of combination inhaled corticosteroid/long-acting β(2)-adrenergic agonist medications in African American asthmatic patients is limited.
  
  
  OBJECTIVE
  We sought to assess safety and asthma control with a budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus budesonide over 1 year in African American patients.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  In this population budesonide/formoterol pMDI was well tolerated over 12 months, with a safety profile similar to that of budesonide; the asthma exacerbation rate was reduced by 38.5% versus budesonide.
authors.affiliation: Center for Managing Chronic Disease, University of Michigan School of Public Health, Ann Arbor, MI 48109-2029, USA. docrbrown@gmail.com
authors.forename: Randall W
authors.initials: RW
authors.lastname: Brown
authors.forename: Christopher D
authors.initials: CD
authors.lastname: O'Brien
authors.forename: Ubaldo J
authors.initials: UJ
authors.lastname: Martin
authors.forename: Tom
authors.initials: T
authors.lastname: Uryniak
authors.forename: Kathy L
authors.initials: KL
authors.lastname: Lampl
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001741:Black or African American / Q000208:ethnology*; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy* / Q000208:ethnology / Q000276:immunology; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D012449:Safety; D016896:Treatment Outcome; D014481:United States
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate