Chest
Volume 130, Issue 2, August 2006, Pages 334-342
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Original Research: COPD
Nurse-Conducted Smoking Cessation in Patients With COPD Using Nicotine Sublingual Tablets and Behavioral Support

https://doi.org/10.1378/chest.130.2.334Get rights and content

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 FEV1, 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.

Section snippets

Patients

Patients with COPD previously diagnosed by a physician were recruited from seven lung clinics using newspaper advertisements in some centers. The first patient was enrolled in February 2002, and the last patient was enrolled in June 2004. Patients enrolled were aged ≥ 18 years; were smoking one or cigarettes a day; had persistent airway obstruction with FEV1/FVC < 70% and FEV1 < 90% of predicted normal value; and were willing to follow the study protocol. Lung function testing was performed

Baseline Characteristics and Study Completion

A total of 370 COPD patients were enrolled in the four treatment arms (Table 1). Overall, the average age was 61.0 years and mean FEV1 was 55.8% of predicted. In terms of COPD severity, 9% of subjects had FEV1 > 80% of predicted, 53% had FEV1 50 to 80% of predicted, 30% had FEV1 30 to 50% of predicted, and 8% had FEV1 < 30% of predicted. At baseline, the study population smoked a mean of 19.6 cigarettes per day (mean, 42.7 pack-years). Fewer than one tenth of those enrolled smoked < 7

Efficacy of NRT for Smoking Cessation in COPD Patients

This is the first randomized, controlled trial to demonstrate the efficacy of NRT for smoking cessation in patients with all stages of COPD and also in smokers who consume < 15 cigarettes per day. The main finding was more than a doubling of sustained abstinence rates with nicotine sublingual tablets vs placebo in a group of COPD patients with mild, moderate, and severe reduction in lung function. The actual 1-year quit rate of 14% with the nicotine sublingual tablet is in the same range as

CONCLUSION

The results demonstrate that the use of sublingual nicotine tablets in conjunction with a nursing-run cessation program results in higher rates of smoking cessation compared to placebo. The quit rate achieved in our study was comparable to that achieved with NRT in “healthy smokers.” NRT should be offered to patients with COPD as part of a smoking cessation program.

At this time, data are insufficient to draw conclusions about the relative efficacy of different forms of NRT in COPD patients, but

ACKNOWLEDGMENT

We thank the nurses in all seven centers for their assistance in this study.

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

    Other recruiting pulmonary departments are Helsingør Sygehus; Odense University Hospital; Århus Kommunehospital; Bispebjerg Hospital; Nykøbing Falster Sygehus; Frederiksberg Hospital.

    The Danish Medical Research Council provided the major grant for this study ($375,000; No. 9900732 kg/mp). Pfizer Consumer Healthcare, Sweden, supplied the study drugs used in the trial and provided grant support ($25,000).

    Dr. Mikkelsen and Ms. Bremann have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. Dr. Tønnesen has served on advisory boards regarding smoking cessation agents, has participated in clinical trials with smoking cessation drugs, has received honorary for scientific talks and travel grants from Pfizer, GlaxoSmithKline, and Sanofi Aventis.

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