Context: Few studies have examined the effect of nicotine replacement therapy (NRT) in COPD patients.

Study objective: To evaluate the efficacy of nicotine sublingual tablets and two levels of support for smoking cessation in COPD patients.

Design: Double-blind, multicenter, placebo-controlled smoking cessation trial.

Setting: Pulmonary outpatient clinics.

Patients: Three hundred seventy COPD patients who smoked a mean of 19.6 cigarettes per day (mean, 42.7 pack-years; mean FEV(1), 56% of predicted).

Interventions: Nicotine sublingual tablet or placebo for 12 weeks combined with either low support (four visits plus six telephone calls) or high support (seven visits plus five telephone calls) provided by nurses.

Measurements: Carbon monoxide-verified abstinence rates and St. George Respiratory Questionnaire (SGRQ) assessed at 6 months and 12 months.

Results: Two hundred eighty-eight of 370 patients were evaluable for the final study end points. Smoking cessation rates were statistically significantly superior with sublingual nicotine vs placebo for all measures of abstinence: 6-month point prevalence, 23% vs 10%; 12-month point prevalence, 17% vs 10%. There was no significant difference in effect between low vs high behavioral support. The SGRQ score improved significantly in abstainers vs nonabstainers; the changes in mean scores were -10.9 vs - 2.9 for total score, and - 28.6 vs - 2.3 for symptom score, respectively.

Conclusions: This trial demonstrated the long-term efficacy of NRT for cessation for the general population of COPD smokers, regardless of daily cigarette consumption. Cessation success rates were in the same range as in healthy smokers, and abstinence improved SGRQ scores. NRT should be used to aid cessation in all smokers with COPD, regardless of disease severity and number of cigarettes smoked.