| Sumario: | Smokers who continue to smoke despite being diagnosed with chronic obstructive pulmonary disease (COPD) may have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might provide an alternative strategy for patients who are not ready or are unable to quit immediately, providing either a strategy for risk reduction or a pathway for later cessation. OBJECTIVES: The purpose of this study was to determine whether LT-NRT compared with standard smoking cessation (SSC) would reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates. METHODS: Smokers with clinically diagnosed COPD (n = 398) were randomly assigned to receive either (1) SSC consisting of cessation counseling at baseline, with 4 follow-up counseling calls and 10 weeks of combination NRT provided to support those who set a quit date; or (2) LT-NRT with up to 12 months of combination NRT and 4 counseling calls and 3 in-person sessions focused on titrating their NRT dosage to reduce cigarette consumption before setting a quit date and to support quitting and abstinence maintenance 6 months post quitting. Follow-up at 3, 6, and 12 months assessed smoking status, exposure to carbon monoxide (CO), a smoking-related carcinogen (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol [NNAL]), functional status, and smoking-related hospitalizations. The primary outcome was 7-day, CO-verified (<10 ppm), point prevalence abstinence at 12 months. Input into the design and conduct of the study was provided by patients and community stakeholders. RESULTS: Groups were similar at baseline; participants were 60% female and, on average, 56 (SD, 9.28) years old with a COPD history of 6.9 (SD, 7.52) years, who smoked an average of 23.1 (SD, 12.26) cigarettes per day (CPD). At 12 months, CO-verified, 7-day point prevalence abstinence was 11.7% and 12.2% in the SSC and LT-NRT groups, respectively (P = .88). The continuing smokers in the SSC and LT-NRT arms, respectively, reduced their self-reported cigarette consumption by 12.4 and 14.5 CPD, exhaled CO by 5.5 and 7.8 ppm, and mean urinary NNAL by 21.7% and 23.0%. Over the course of the 12-month follow-up, these changes were significantly different from baseline but did not differ significantly between treatment arms. Respiratory symptoms, functional status, and hospitalizations and emergency department visits were also not significantly different between the 2 groups over the 12-month follow-up period. LT-NRT recipients had more gastrointestinal and skin-related side effects of treatment; major adverse cardiac events were similar in the 2 groups. CONCLUSIONS: Smokers with COPD treated with either SSC or LT-NRT had similar reductions in tobacco exposure and similar, modest rates of cessation. Because SSC has a shorter duration of treatment and fewer side effects, it appears to be the preferred treatment for smokers ready to quit. LT-NRT leads to comparable results and would appear to be an option for smokers who are not immediately willing to make a quit attempt. LIMITATIONS AND SUBPOPULATION CONSIDERATIONS: Most participants in the SSC arm (96%) were willing to set a quit date; findings might be different in actual clinical practice, which might include more smokers not interested in quitting in the immediate future. Low rates of cessation overall limited the potential for analyses of differential effects in subpopulations.
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