title: Effect of smoking status on the efficacy of the SMART regimen in high risk asthma.
abstract: The optimal management of people with asthma with a significant smoking history is uncertain. The aim of this study was to determine whether the efficacy/safety profile of single combination inhaled corticosteroid (ICS)/long acting beta-agonist (LABA) inhaler maintenance and reliever therapy is influenced by smoking status.
  
  
  
  We undertook secondary analyses from an open-label 24-week randomized study of 303 high risk adult asthma patients randomized to budesonide/formoterol 200/6-µg-metred dose inhaler for maintenance (two actuations twice daily) and either budesonide/formoterol 200/6-µg-metred dose inhaler one actuation ('single ICS/LABA maintenance and reliever therapy (SMART)' regimen) or salbutamol 100 µg 1-2 actuations for symptom relief ('Standard' regimen). Smoking status was classified in to three groups, as 'current', 'ex' or 'never', and a smoking/treatment interaction term tested for each outcome variable. The primary outcome variable was number of participants with at least one severe exacerbation.
  
  
  
  There were 59 current, 97 ex and 147 never smokers included in the analyses. The smoking status/treatment interaction term was not statistically significant for any of the outcome measures. With adjustment for smoking status, the number of participants with severe exacerbations was lower with the SMART regimen (OR 0.45, 95% CI: 0.26-0.77, P = 0.004; P value for interaction between smoking status and treatment 0.29).
  
  
  
  We conclude that the favourable safety/efficacy profile of the SMART regimen applies to patients with high risk asthma, irrespective of smoking status.
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital & Coast District Health Board, Wellington, New Zealand.
authors.forename: Janine
authors.initials: J
authors.lastname: Pilcher
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital & Coast District Health Board, Wellington, New Zealand.|Nottingham Respiratory Research Unit, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Mitesh
authors.initials: M
authors.lastname: Patel
authors.affiliation: Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.
authors.forename: Helen K
authors.initials: HK
authors.lastname: Reddel
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Alison
authors.initials: A
authors.lastname: Pritchard
authors.affiliation: University of Auckland, Auckland, New Zealand.
authors.forename: Peter
authors.initials: P
authors.lastname: Black
authors.affiliation: Nottingham Respiratory Research Unit, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Dominick
authors.initials: D
authors.lastname: Shaw
authors.affiliation: Clinicanz, Tauranga, New Zealand.
authors.forename: Shaun
authors.initials: S
authors.lastname: Holt
authors.affiliation: Capital & Coast District Health Board, Wellington, New Zealand.|University of Otago, Wellington, New Zealand.
authors.forename: Mark
authors.initials: M
authors.lastname: Weatherall
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital & Coast District Health Board, Wellington, New Zealand.
authors.forename: Richard
authors.initials: R
authors.lastname: Beasley
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D000068759:Formoterol Fumarate / Q000008:administration & dosage*; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D012306:Risk; D012907:Smoking / Q000503:physiopathology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D019819:Budesonide; D000420:Albuterol; D000068759:Formoterol Fumarate
keywords: adult; asthma; medication adherence; randomized controlled trial; smoking