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Original Research: ASTHMA |

The Effects of Inhaled Budesonide on Lung Function in Smokers and Nonsmokers With Mild Persistent Asthma

Paul M. O'Byrne, MB, FCCP; Carl Johan Lamm, PhD; William W. Busse, MD; Wan C. Tan, MD, FCCP; Søren Pedersen, MD; the START Investigators Group
Author and Funding Information

Affiliations: From the Department of Medicine (Dr. O'Byrne), McMaster University, Hamilton, ON, Canada; AstraZeneca R&D (Dr. Lamm), Lund, Sweden; University of Wisconsin (Dr. Busse), Madison, WI; University of British Columbia (Dr. Tan), Vancouver, BC, Canada; and the Department of Pediatrics (Dr. Pedersen), University of Odense, Kolding Hospital, Kolding, Denmark.

Correspondence to: Paul O'Byrne, MB, FCCP, Department of Medicine, McMaster University Medical Center, 1200 Main St West, Hamilton, ON, Canada L8N 3Z5; e-mail: obyrnep@mcmaster.ca


Funding/Support: The START study was funded by AstraZeneca, Lund, Sweden.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).


© 2009 American College of Chest Physicians


Chest. 2009;136(6):1514-1520. doi:10.1378/chest.09-1049
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Background:  Previous studies have suggested a reduced benefit from therapy with inhaled corticosteroids (ICSs) in asthmatic patients who smoke. The objective of this post hoc study was to study the effects of low-dose inhaled budesonide on lung function in smokers and nonsmokers with mild persistent asthma.

Methods:  Adult patients (age, ≥ 18 years) in the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study, a 3-year, randomized, placebo-controlled, double-blind study, were stratified according to their smoking habits. The effects on lung function of therapy with budesonide vs placebo were compared in 492 asthmatic patients who smoked habitually and 2,432 nonsmokers.

Results:  When treated with placebo, newly diagnosed asthmatic patients who smoke had a greater 3-year decline in post-bronchodilator therapy FEV1, the change being −263.9 mL (SE, 21.8), when compared with nonsmokers on placebo, which was −180.8 mL (SE, 10.6), the mean difference being −83.1 mL (p < 0.001). Budesonide treatment was associated with a statistically significant 3-year increase in post-bronchodilator therapy FEV1 in both groups. The effect of budesonide vs placebo was 71.5 mL (p = 0.011) in smokers and 46.5 mL (p = 0.001) in nonsmokers. The corresponding effect in pre-bronchodilator therapy FEV1 was 118.1 mL (p = 0.002) in smokers and 72.9 mL (p < 0.001) in nonsmokers.

Conclusions:  Asthmatic patients who smoke, and are not treated with ICSs, have a greater decline in lung function than asthmatic patients who do not smoke. The benefits of therapy with inhaled budesonide on preventing lung function decline are similar in smokers and nonsmokers with mild persistent asthma.

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