Very few previous studies of pharmacotherapy for smokers with COPD have been published. In one such study, as noted by Kotz and Schayck, smokers with COPD who had received bupropion achieved significantly higher continuous abstinence rates than smokers treated with placebo at 3 and 6 months,3 implying that the smokers treated with placebo in the varenicline COPD trial were deprived of an effective pharmacologic aid for smoking cessation as a positive control. However, the bupropion COPD trial, which included a follow-up period up to 1 year, failed to demonstrate a significant difference between bupropion and placebo in continuous abstinence rates at the end of the follow-up period. Consequently, it has not been convincingly demonstrated that bupropion is an effective pharmacologic aid for smoking cessation and sustained abstinence in smokers with COPD. In the absence of evidence that alternative pharmacologic aids for smoking cessation have long-term efficacy in smokers with COPD, we believe that the use of a placebo arm in the varenicline COPD trial (in which all subjects received the benefits of counseling) was justified in order to test the hypothesis that varenicline plus counseling is an effective treatment strategy for promoting long-term abstinence from smoking compared with counseling alone (ie, placebo medication plus counseling).