title: Budesonide/formoterol pressurized metered-dose inhaler versus budesonide: a randomized controlled trial in black patients with asthma.
abstract: OBJECTIVE
  Concerns exist that responses to long-acting β(2)-adrenergic agonists in black patients may differ from the general population. The efficacy and safety of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus budesonide dry powder inhaler (BUD DPI) were evaluated in adolescent and adult black asthma patients.
  
  
  METHODS
  This 12-week, randomized, double-blind, multicenter, phase IV US study was conducted in 311 self-reported black patients aged ≥12 years with moderate to severe persistent asthma, previously receiving medium- to high-dose inhaled corticosteroid. After 2 weeks on BUD 90 μg × 2 inhalations twice daily (bid), symptomatic patients were randomized to BUD/FM 160/4.5 μg × 2 inhalations bid or BUD 180 μg × 2 inhalations bid.
  
  
  RESULTS
  Improvement in predose forced expiratory volume in 1 second from baseline to the treatment mean (primary variable) was greater with BUD/FM versus BUD (0.16 vs. 0.07 L; p = .008); this effect was also observed at weeks 2, 6, and end of treatment (p ≤ .032). Greater improvements (p < .001) in peak expiratory flow with BUD/FM versus BUD were seen at first measurement and maintained during 12 weeks (morning: 25.34 vs. 7.53 L/minute, respectively; evening: 21.61 vs. 7.67 L/minute, respectively); greater improvements in daily asthma symptom score and rescue medication use were also observed (p ≤ .039). Both treatments were well tolerated, with similar safety profiles.
  
  
  CONCLUSIONS
  In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.
authors: California Allergy & Asthma Medical Group, Los Angeles, CA 90025, USA. spector@calallergy.com
authors: Sheldon L
authors: SL
authors: Spector
authors: Ubaldo J
authors: UJ
authors: Martin
authors: Tom
authors: T
authors: Uryniak
authors: Christopher D
authors: CD
authors: O'Brien
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data*; D000368:Aged; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology*; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D015999:Multivariate Analysis; D012016:Reference Values; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate