title: Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma.
abstract: OBJECTIVE
  There are significant health disparities between Māori and non-Māori with asthma, a pattern seen between other ethnic populations. This study investigates outcomes for Māori in a randomized controlled trial (RCT) of combination budesonide/formoterol inhaler therapy in asthma.
  
  
  METHODS
  This 24-week multicentre RCT recruited 303 adult asthma patients, 44 of whom were Māori. Participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ('SMART') regimen or 'standard' regimen (combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever). Outcomes included patterns of beta-agonist inhaler use including 'high use' of reliever therapy (>8 actuations of budesonide/formoterol in excess of four maintenance doses per day for SMART and >16 actuations per day of salbutamol for standard). Differences in outcomes for Māori versus non-Māori were assessed using an interaction term between ethnicity and treatment.
  
  
  RESULTS
  With adjustment for ethnicity, the SMART group had fewer days of high use (relative rate (RR) 0.57 (95% confidence interval (CI): 0.38-0.85)), days of high use without medical review within 48 h (RR 0.49 (95% CI: 0.32-0.75)) and severe exacerbations (RR 0.54 (95% CI: 0.36-0.81)) compared with standard. The magnitude of the benefit from the SMART regimen was similar in Māori and non-Māori. Regardless of treatment regimen, Māori demonstrated more days of high use, high use without medical review and underuse of maintenance therapy.
  
  
  CONCLUSIONS
  The SMART regimen has a favourable risk/benefit profile in Māori. Days of high use, days of high use without medical review and underuse of maintenance treatment were greater in Māori, regardless of treatment regimen.
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.forename: Mitesh
authors.initials: M
authors.lastname: Patel
authors.forename: Ann
authors.initials: A
authors.lastname: Smith
authors.forename: Cheryl
authors.initials: C
authors.lastname: Davies
authors.forename: Alison
authors.initials: A
authors.lastname: Pritchard
authors.forename: Justin
authors.initials: J
authors.lastname: Travers
authors.forename: Peter
authors.initials: P
authors.lastname: Black
authors.forename: Mark
authors.initials: M
authors.lastname: Weatherall
authors.forename: Richard
authors.initials: R
authors.lastname: Beasley
authors.forename: Matire
authors.initials: M
authors.lastname: Harwood
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000208:ethnology*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009520:New Zealand; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000420:Albuterol; D000068759:Formoterol Fumarate
keywords: Māori; asthma; health disparity; randomized controlled trial; single combination budesonide/formoterol inhaler as maintenance and reliever therapy