Do asthmatic smokers benefit as much as non-smokers on budesonide/formoterol maintenance and reliever therapy? Results of an open label study

Onno C P van Schayck, John Haughney, Michel Aubier, Olof Selroos, Tommy Ekström, Juliette Ostinelli, Roland Buhl

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)


BACKGROUND: Studies with inhaled corticosteroids (ICS) in smoking asthmatics have mostly shown poorer treatment responses than in non-smoking asthmatics.

METHODS: EuroSMART, an open, randomised, 6-month study, compared budesonide/formoterol (Symbicort (®) Turbuhaler(®))(h) maintenance and reliever therapy (Symbicort SMART(®)) at two maintenance doses of budesonide/formoterol (160/4.5 μg), 1 × 2 and 2 × 2, in patients with asthma who were symptomatic despite treatment with ICS ± long-acting β(2)-agonists. The 8424 randomised patients included 886 smokers (11%; aged <40 years or with a smoking history <10 pack-years if older), who were compared with a propensity-matched group of non-smokers. At baseline, smokers had lower post-bronchodilator peak expiratory flow, lower peak flow reversibility and used more reliever medication per day. Severe asthma exacerbations were counted and changes in five-item Asthma Control Questionnaire (ACQ-5) scores from baseline calculated.

RESULTS: There were 48 and 47 exacerbations in smokers and non-smokers, respectively. Mean time to first severe exacerbation was not statistically different between the two groups. The mean change in ACQ-5 score was significantly greater in non-smokers. Considering the two treatment options there was a statistically significant prolonged time to first severe exacerbation with 2 × 2 versus 1 × 2 in the smokers, but not in the non-smokers. In smokers, the reductions in ACQ-5 scores, asthma symptoms, use of as-needed medication and awakenings were also all significant in favour of 2 × 2 with similar or greater changes than in smokers treated with 1 × 2.

CONCLUSION: Asthmatic patients with a limited smoking history benefit from treatment with budesonide/formoterol maintenance and reliever therapy with dosing 2 × 2 being superior to 1 × 2.

Original languageEnglish
Pages (from-to)189-196
Number of pages8
JournalRespiratory Medicine
Issue number2
Publication statusPublished - Feb 2012


  • administration, inhalation
  • adult
  • anti-asthmatic agents
  • asthma
  • bronchodilator agents
  • budesonide
  • disease progression
  • dose-response relationship, drug
  • drug administration schedule
  • drug therapy, combination
  • ethanolamines
  • female
  • formoterol fumarate
  • humans
  • male
  • peak expiratory flow rate
  • smoking
  • surveys and questionnaires
  • treatment outcome


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