TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol
Status:
Not yet recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
Background:
Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD) and it
contributes to the development of many other serious diseases. Acute exacerbations of COPD
(AECOPD) often lead to hospitalization. Severe hospitalization-requiring AECOPD carries very
high economic costs for the healthcare system, and personal costs for patients. Smoking
cessation in COPD for the healthcare system, and personal costs for patients. Smoking
cessation in COPD patients is known to improve survival and reduce the number of AECOPD.
However, smoking cessation interventions in these patients have only been successful for
consistent smoking abstinence in 12 months in approximately 15-20%. Thus, more effective
interventions are needed for this patient group.
Aims:
The aim of this study is to determine, among people with chronic obstructive pulmonary
disease (COPD), whether a "high-intensive" smoking cessation intervention in comparison to a
standard intervention can lead to permanent, >12 months, smoking cessation in a higher
proportion.
Methods:
This study is a randomized trial in active smokers with COPD and who have lost less than 50%
lung function. A total of 600 participants will be randomly assigned 1:1 to either a standard
treatment (guideline-based municipal smoking cessation programme, "low intensity" group), or
an intervention group ("high-intensity" group), which consists of group sessions, telephone
consultations, behavior design, hotline, "buddy-matching" (smoker matched with COPD patient
who stopped). Both groups will receive pharmacological smoking cessation.
Discussion:
The potential benefit of this project is to prevent smoking-related exacerbations of COPD and
thereby reduce logistics and costs of hospitalization and treatment 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 developing lung cancer and other smoking-related diseases.