TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol-a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of "high-intensity" vs. "low-intensity" smoking cessation intervention in active smokers with chronic obstructive pulmonary disease

Mohamad Isam Saeed, Pradeesh Sivapalan, Josefin Eklöf, Charlotte Suppli Ulrik, Charlotta Pisinger, Therese Lapperre, Philip Tønnesen, Nils Hoyer, Julie Janner, Marie Lavesen Karlsson, Charlotte Sandau Bech, Kristoffer Marså, Nina Godtfredsen, Eva Brøndum, Birgit Munk, Merete Raaschou, Andrea Browatzski, Pernille Lütken, Jens-Ulrik Stæhr Jensen, Mohamad Isam Saeed, Pradeesh Sivapalan, Josefin Eklöf, Charlotte Suppli Ulrik, Charlotta Pisinger, Therese Lapperre, Philip Tønnesen, Nils Hoyer, Julie Janner, Marie Lavesen Karlsson, Charlotte Sandau Bech, Kristoffer Marså, Nina Godtfredsen, Eva Brøndum, Birgit Munk, Merete Raaschou, Andrea Browatzski, Pernille Lütken, Jens-Ulrik Stæhr Jensen

Abstract

Background: Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.

Methods: This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, "low intensity" group) or an intervention ("high-intensity" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and "buddy-matching" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months.

Discussion: The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases.

Trial registration: ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.

Keywords: COPD; Exacerbations; Randomized controlled trial; Smoking cessation; Varenicline.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure: overview of assessments that each participant will undergo and the time schedule for the project

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